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Muthu S, Vadranapu S. Variations in quantifying patient reported outcome measures to estimate treatment effect. World J Methodol 2025; 15:97078. [DOI: 10.5662/wjm.v15.i2.97078] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/22/2024] [Revised: 10/13/2024] [Accepted: 11/06/2024] [Indexed: 11/27/2024] Open
Abstract
In the practice of healthcare, patient-reported outcomes (PROs) and PRO measures (PROMs) are used as an attempt to observe the changes in complex clinical situations. They guide us in making decisions based on the evidence regarding patient care by recording the change in outcomes for a particular treatment to a given condition and finally to understand whether a patient will benefit from a particular treatment and to quantify the treatment effect. For any PROM to be usable in health care, we need it to be reliable, encapsulating the points of interest with the potential to detect any real change. Using structured outcome measures routinely in clinical practice helps the physician to understand the functional limitation of a patient that would otherwise not be clear in an office interview, and this allows the physician and patient to have a meaningful conversation as well as a customized plan for each patient. Having mentioned the rationale and the benefits of PROMs, understanding the quantification process is crucial before embarking on management decisions. A better interpretation of change needs to identify the treatment effect based on clinical relevance for a given condition. There are a multiple set of measurement indices to serve this effect and most of them are used interchangeably without clear demarcation on their differences. This article details the various quantification metrics used to evaluate the treatment effect using PROMs, their limitations and the scope of usage and implementation in clinical practice.
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Affiliation(s)
- Sathish Muthu
- Department of Orthopaedics, Orthopaedic Research Group, Coimbatore 641045, Tamil Nadu, India
- Department of Orthopaedics, Government Medical College, Karur 639004, Tamil Nadu, India
- Department of Biotechnology, Karpagam Academy of Higher Education, Coimbatore 641021, Tamil Nadu, India
| | - Srujun Vadranapu
- Department of Orthopaedics, Royal Care Super Speciality Hospital, Coimbatore 641062, Tamil Nadu, India
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Manoharan R, Srikandarajah N, Murray JC, Nielsen C, Singh S, Christie S, Yang MMH, Weber M, Larue B, Kelly A, Paquet J, Charest-Morin R, Hogan G, Glennie A, Anh H, Wai E, Dea N, Mason N, Thomas K, Fisher C, Hall H, Bailey C, Canizares M, Rampersaud YR. The impact of elective spine surgery in Canada for degenerative conditions on patient reported health-related quality of life outcomes. Sci Rep 2025; 15:19143. [PMID: 40450143 DOI: 10.1038/s41598-025-03613-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2024] [Accepted: 05/21/2025] [Indexed: 06/03/2025] Open
Abstract
The impact of spine surgery on Health-Related Quality-of-Life (HRQoL) outcomes across common spinal degenerative diagnoses is not well characterised. A prospective observational study of patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN) registry was performed. Baseline and 1-year post-operative Short Form-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were collated and compared to normative values from the Canadian General Population (CGP). The percentage of patients achieving the PCS Minimum Clinically Important Difference (MCID) was quantified. 5049 patients were included in the analysis. The mean pre-operative SF-12 PCS was 29.5 and MCS was 44.1. This improved to a mean PCS of 40.5 (p < 0.001) and MCS of 49.3 (p < 0.0001) at 1-year post-operatively. The mean pre-operative PCS was over 2 standard deviations (SD) lower than the normative mean of the CGP; this improved to being close to 1-SD from the normative CGP mean at 1-year post-operatively. Findings were similar across age- and sex-stratified subgroups. Across all conditions, 70-75% of patients achieved the PCS MCID. Fewer patients with cervical myelopathy achieved the PCS MCID (59%). In a surgical cohort, patients with degenerative spinal conditions demonstrate a profound reduction in PCS compared to their peers in the CGP. Spinal surgery was impactful in improving physical function HRQoL outcomes in the majority, but not typically to average population norms.
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Affiliation(s)
- Ragavan Manoharan
- University of Toronto Spine Program, Toronto Western Hospital, Toronto, ON, Canada
- Department of Neurosurgery, Royal North Shore Hospital, Sydney, Australia
| | - Nisaharan Srikandarajah
- University of Toronto Spine Program, Toronto Western Hospital, Toronto, ON, Canada
- Department of Neurosurgery, The Walton Centre, Liverpool, United Kingdom
- Faculty of Health and Life Sciences, University of Liverpool, Liverpool, England
| | - Jean-Christophe Murray
- Division of Orthopaedic Surgery, Department of Surgery, CHU de Québec - Université Laval Quebec City, Quebec, QC, Canada
| | - Christopher Nielsen
- Schroeder Arthritis Institute, Krembil Research Institute, Department of Surgery, Division of Orthopaedic Surgery, University Health Network, University of Toronto, Orthopaedics, Toronto, ON, Canada
| | - Supriya Singh
- London Health Science Centre Combined Orthopaedic and Neurosurgery Spine Program, Schulich School of Medicine, Western University, London, ON, Canada
| | - Sean Christie
- Department of Surgery, Division of Neurosurgery, Dalhousie University, Halifax, NS, Canada
| | - Michael M H Yang
- University of Calgary Spine Program, University of Calgary, Calgary, AB, Canada
| | - Michael Weber
- Department of Surgery, Division of Orthopaedics, Montreal General Hospital, McGill University, Montreal, QC, Canada
| | - Bernard Larue
- Département de Chirurgie, Faculté de Médecine et des Sciences de la Santé, Université de Sherbrooke, Sherbrooke, Québec, Canada
| | - Adrienne Kelly
- Sault Area Hospital, Northern Ontario School of Medicine, Sault Ste Marie, Sault Ste. Marie, ON, Canada
| | - Jerome Paquet
- Centre de Recherche CHU de Quebec, CHU de Quebec-Universite Laval, Quebec City, QC, Canada
| | - Raphaele Charest-Morin
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Vancouver, BC, Canada
| | - Guy Hogan
- Department of Orthopaedic Surgery, Health Sciences Centre, Newfoundland and Labrador, St. John's, Canada
| | - Andrew Glennie
- Department of Surgery, Division of Orthopedics, Dalhousie University, Halifax, NS, Canada
| | - Henry Anh
- Division of Orthopaedic Surgery, St. Michael's Hospital, Toronto, ON, Canada
| | - Eugene Wai
- Division of Orthopaedic Surgery, University of Ottawa, The Ottawa Hospital, Ottawa, ON, Canada
| | - Nicolas Dea
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Vancouver, BC, Canada
| | - Neil Mason
- Canada East Spine Centre, Division of Orthopaedic Surgery, Horizon Health Network, Zone 2, Saint John, New Brunswick, Canada
- Dalhousie University Faculty of Medicine, Halifax, NS, Canada
| | - Kenneth Thomas
- University of Calgary Spine Program, University of Calgary, Calgary, AB, Canada
| | - Charles Fisher
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Vancouver, BC, Canada
| | - Hamilton Hall
- Department of Surgery, University of Toronto, Toronto, ON, Canada
| | - Christopher Bailey
- London Health Science Centre Combined Orthopaedic and Neurosurgery Spine Program, Schulich School of Medicine, Western University, London, ON, Canada
| | - Mayilee Canizares
- Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, ON, Canada
| | - Yoga Raja Rampersaud
- Schroeder Arthritis Institute, Krembil Research Institute, Department of Surgery, Division of Orthopaedic Surgery, University Health Network, University of Toronto, Orthopaedics, Toronto, ON, Canada.
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Hepprich M, Fischer J, Cattaneo M, Ferreira A, Herzig D, Bally L, Donath M. Canakinumab for the treatment of postprandial hypoglycaemia: study protocol for a randomised, placebo-controlled, parallel-group, double-blind, multicentric, superiority trial-the CanpHy study. BMJ Open 2025; 15:e097981. [PMID: 40425249 PMCID: PMC12107589 DOI: 10.1136/bmjopen-2024-097981] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/14/2024] [Accepted: 03/18/2025] [Indexed: 05/29/2025] Open
Abstract
INTRODUCTION Postbariatric hypoglycaemia (PBH) is a complex medical condition with a significant impact on patients' quality of life. The underlying mechanisms remain to be elucidated. We have shown that food ingestion increases IL-1β and subsequently stimulates insulin secretion. We therefore hypothesised that overactivation of the IL-1β pathway could lead to PBH by promoting excessive insulin secretion after a meal. In a proof-of-concept study, we have shown that acute treatment with the IL-1 receptor antagonist anakinra can attenuate PBH after a single liquid mixed meal. This study aims to validate this therapeutic approach over a longer period of time using the long-acting anti-IL-1β antibody canakinumab. METHODS AND ANALYSIS In this prospective, randomised, double-blind, placebo-controlled, multicentre trial, we plan to enrol 62 adult patients after bariatric surgery with frequent, postprandial hypoglycaemia (ie, <3.0 mmol/L and at least five hypoglycaemic episodes per week). Eligible subjects will be randomised to receive either single-dose 150 mg canakinumab (Ilaris, Novartis) subcutaneously (s.c.) or matched placebo (1.0 mL physiologic saline). For 28 days, patients are required to wear a blinded continuous glucose monitoring device (CGMS, Dexcom G6) and use a diary to track their hypoglycaemic episodes. Primary outcomes include health-related quality of life, measured by the SF-36, as well as postprandial hypoglycaemic events (glucose <3.0 mmol/L). A significant improvement in any one of these outcomes will be considered sufficient to demonstrate the clinical superiority of canakinumab over placebo. Secondary outcomes include patient-oriented measures such as postprandial hypoglycaemic symptoms, hypoglycaemia unawareness, fear of hypoglycaemia, as well as metabolic measures and safety assessments. ETHICS AND DISSEMINATION The trial was approved by the Cantonal Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' in January 2022 (#2021-02325), as well as by Swissmedic in April 2022 (#701280). Current, approved protocol version 1.3 of 28.03.2023. The study is actively recruiting. Results will be published in a relevant scientific journal and communicated to participants and relevant institutions through dissemination activities. Individual data are accessible on request. TRIAL REGISTRATION The study is registered with the www. CLINICALTRIALS gov registry (NCT05401578) and the Swiss National Clinical Trials Portal (SNCTP) on www.kofam.ch (SNCTP000004838).
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Affiliation(s)
- Matthias Hepprich
- Division of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland
- Metabolic Center, Olten Cantonal Hospital, Olten, SO, Switzerland
- University of Basel, Basel, BS, Switzerland
| | - Justus Fischer
- Division of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland
- University of Basel, Basel, BS, Switzerland
| | - Marco Cattaneo
- Department of Clinical Research, University of Basel, Basel, BS, Switzerland
| | | | - David Herzig
- Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, Bern, Switzerland
| | - Lia Bally
- Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, Bern, Switzerland
| | - Marc Donath
- Division of Endocrinology, Diabetes and Metabolism, University Hospital Basel, Basel, Switzerland
- University of Basel, Basel, BS, Switzerland
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Liu P, Afzal I, Asopa V, Clement ND, Patel V. Changes and thresholds in the Oxford Shoulder Score following shoulder arthroplasty: Minimal clinically important difference, minimal important and detectable changes, and patient-acceptable symptom state. Shoulder Elbow 2024; 16:507-517. [PMID: 39479460 PMCID: PMC11520022 DOI: 10.1177/17585732231176423] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2022] [Revised: 04/24/2023] [Accepted: 05/01/2023] [Indexed: 11/02/2024]
Abstract
Background The minimal clinically important difference, minimal important change, minimal detectable change and patient-acceptable symptom state are poorly defined for the Oxford Shoulder Score following shoulder arthroplasty. The study's aim was to calculate their values. Methods One hundred patients underwent shoulder arthroplasty and completed pre and 1-year postoperative Oxford Shoulder Score. Patient satisfaction was assessed at 1-year using a visual analogue scale from 0 to 100: 'very satisfied' (>80), 'satisfied' (>60-80), and 'unsatisfied' (≤60). The difference between patients recording 'unsatisfied' (n = 11) and 'satisfied' (n = 16) was used to define the minimal clinically important difference. MICcohort was calculated as the change in Oxford Shoulder Score for those satisfied (>60). Receiver-operating characteristic curve analysis was used to determine the MICindividual and patient-acceptable symptom state. Distribution-based methodology was used for the minimal detectable change. Results The minimal clinically important difference was 6.9 (95% confidence interval 0.7-13.1, p = 0.039). The MICcohort was 11.6 (95% confidence interval 6.8-16.4) and MICindividual 13. The minimal detectable change was 6.6 and the patient-acceptable symptom state was defined as ≥29. Discussion The minimal clinically important difference and minimal important change can assess whether there is a clinical difference between two groups and whether a cohort/patient has had a meaningful change in their Oxford Shoulder Score, respectively. These were greater than measurement error (minimal detectable change), suggesting a real change. The patient-acceptable symptom state can be used as a marker of achieving satisfaction.
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Affiliation(s)
- Perry Liu
- South West London Elective Orthopaedic Centre, Epsom, UK
| | - Irrum Afzal
- South West London Elective Orthopaedic Centre, Epsom, UK
| | - Vipin Asopa
- South West London Elective Orthopaedic Centre, Epsom, UK
| | - Nick D Clement
- South West London Elective Orthopaedic Centre, Epsom, UK
- Department of Orthopaedics, Royal Infirmary of Edinburgh, Edinburgh, UK
| | - Vipul Patel
- South West London Elective Orthopaedic Centre, Epsom, UK
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Hendrickson NR, Haselhuhn JJ, Odland K, Sembrano JN, Martin CT, Jones KE, Polly DW. Sacropelvic Fixation with Porous Fusion/Fixation Screws: A Technical Note and Retrospective Review. World Neurosurg 2024; 190:172-180. [PMID: 38878891 DOI: 10.1016/j.wneu.2024.06.046] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2024] [Accepted: 06/09/2024] [Indexed: 08/06/2024]
Abstract
OBJECTIVE The goal of this study was to analyze our initial experience using a novel porous fusion/fixation screw (PFFS) for pelvic fixation and determine our rate of screw malposition requiring intraoperative repositioning. METHODS We reviewed 83 consecutive patients who underwent sacropelvic fixation with PFFS at our institution from June 1, 2022 to June 30, 2023 using intraoperative computed tomography-based computer-assisted navigation via an open posterior approach. Following PFFS insertion, intraoperative computed tomography scans were obtained to assess screw positioning. Demographic data were collected, and operative reports and patient images were reviewed to determine what implants were used and if any PFFS required repositioning. RESULTS Seventy-four patients (26M:48F) were included, and 57 (77.0%) had a prior sacroiliac joint or lumbar spine surgery. A stacked screw configuration was used in 62/74 cases (83.8%). A total of 235 PFFS were used and six (2.6%) were malpositioned. Of 88 cephalic screws placed in stacked configuration, 4 were malpositioned (4.5%) and 1/123 caudal screws were malpositioned (0.8%). One of 24 sacral-alar-iliac screws placed in a stand-alone configuration was malpositioned (4.2%). Malpositions included 4 medial, 1 lateral, and 1 inferior, and all were revised intraoperatively without major sequela. CONCLUSIONS Although PFFSs are larger than traditional sacropelvic fixation screws, stacked sacral-alar-iliac instrumentation can be done safely with computer-assisted navigation. We found a low malposition rate in our initial series of patients, the majority being the cephalad screw in a stacked configuration. This isn't surprising, as these are placed after the caudal screws, which reduces the available corridor size and increases the placement difficulty.
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Affiliation(s)
- Nathan R Hendrickson
- Departments of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
| | - Jason J Haselhuhn
- Departments of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA
| | - Kari Odland
- Departments of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA
| | - Jonathan N Sembrano
- Departments of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA
| | - Christopher T Martin
- Departments of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA
| | - Kristen E Jones
- Departments of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA; Departments of Neurosurgery, University of Minnesota, Minneapolis, Minnesota, USA
| | - David W Polly
- Departments of Orthopedic Surgery, University of Minnesota, Minneapolis, Minnesota, USA; Departments of Neurosurgery, University of Minnesota, Minneapolis, Minnesota, USA
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Coronado RA, Pennings JS, Master H, Brintz CE, Cole KR, Helmy J, Oleisky ER, Davidson C, Abtahi AM, Stephens BF, Archer KR. The Combined Influence of Sleep Disturbance and Depression on 12-month Outcomes After Lumbar Spine Surgery. Spine (Phila Pa 1976) 2024; 49:1339-1347. [PMID: 38605675 PMCID: PMC11384552 DOI: 10.1097/brs.0000000000005000] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2024] [Accepted: 03/21/2024] [Indexed: 04/13/2024]
Abstract
STUDY DESIGN Retrospective analysis of prospectively collected data. OBJECTIVE To examine the combined influence of preoperative sleep disturbance and depression on 12-month patient-reported outcomes after lumbar spine surgery (LSS). SUMMARY OF BACKGROUND DATA Psychological and behavioral factors are considered major risk factors for poor outcomes after LSS. However, there is a need to explore the combined effects of preoperative factors such as sleep disturbance and depression. Understanding the influence of sleep disturbance and depression can inform evidence-based preoperative assessment and shared-decision making of preoperative and postoperative treatment. METHODS Data from 700 patients undergoing LSS were analyzed. Preoperative sleep disturbance and depression were assessed with PROMIS subscales. Established thresholds defined patients with moderate/severe symptoms. Outcomes for disability (Oswestry Disability Index) and back and leg pain (Numeric Rating Scales) were assessed preoperatively and at 12 months. Separate multivariable linear regressions examined the influence of each factor on 12-month outcomes with and without accounting for the other and in combination as a 4-level variable: (1) moderate/severe sleep disturbance alone, (2) moderate/severe depression alone, (3) both moderate/severe sleep disturbance and depression, (4) no moderate/severe sleep disturbance or depression. RESULTS Preoperative sleep disturbance and depression were associated with 12-month disability and pain ( P <0.05). After accounting for depression, preoperative sleep disturbance remained associated with disability, while preoperative depression adjusting for sleep disturbance remained associated with all outcomes ( P <0.05). Patients reporting both moderate/severe sleep disturbance and moderate/severe depression had 12.6 points higher disability and 1.5 points higher back and leg pain compared with patients without moderate/severe sleep disturbance or depression. CONCLUSIONS The combination of sleep disturbance and depression impacts postoperative outcomes considerably. The high-risk group of patients with moderate/severe sleep disturbance and depression could benefit from targeted treatment strategies. LEVEL OF EVIDENCE Level II.
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Affiliation(s)
- Rogelio A. Coronado
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Jacquelyn S. Pennings
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Hiral Master
- Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Carrie E. Brintz
- Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Keith R. Cole
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Joseph Helmy
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Emily R. Oleisky
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Claudia Davidson
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Amir M. Abtahi
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Byron F. Stephens
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Kristin R. Archer
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
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Skolasky RL, Finkelstein JA, Schwartz CE. Associations of cognitive appraisal and patient activation on disability and mental health outcomes: a prospective cohort study of patients undergoing spine surgery. BMC Musculoskelet Disord 2024; 25:595. [PMID: 39069610 DOI: 10.1186/s12891-024-07709-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2023] [Accepted: 07/19/2024] [Indexed: 07/30/2024] Open
Abstract
BACKGROUND With the increased use of patient-reported outcomes measures (PROMs) to assess spine surgery outcomes, it is important to understand how patients interpret their health changes over time. The measurement of cognitive-appraisal processes enables the quantification of how individuals think about quality of life (QOL). This study examined how appraisal processes were associated with patients' views of their role in managing their health-patient activation. METHODS This longitudinal cohort study from August 2019 to January 2022 included 222 adults undergoing spine surgery for cervical (n = 107) and/or lumbar (n = 148) pathology at an academic medical center. PROMs assessed disability (Neck Disability Index for cervical or Oswestry Disability Index for lumbar) and mental health (PROMIS-29 v2.0), cognitive-appraisal processes (QOLAPv2-SF), and patient activation (Patient Activation Measure). ANOVA models were used to examine the relationships between QOL and cognitive appraisal processes before and after surgery, overall and stratified by patient-activation stage. Effect sizes facilitated interpretation. RESULTS There were significant improvements in pain-related disability and mental health following surgery. Cognitive appraisal processes explained substantial amounts of variance, particularly with changes in mental health (45% before surgery, 75% at three months, and 63%, at 12-months after surgery). With respect to physical disability, less disability was associated with a lesser focus on negative aspects of QOL. Appraisal explained the most variance before surgery for high-activation patients. At 12-months post-surgery, however, appraisal explained the most variance for the low-activation patients. Appraisal explained similar amounts of variance in mental health at baseline and three-months post-surgery for all activation groups, but substantially more variance in the low-activation group at 12-months post-surgery. There were differences in the direction of appraisal-outcome associations by activation group in selected appraisal items/domains. CONCLUSIONS Cognitive-appraisal processes demonstrate a significant relationship with QOL among spine surgery patients. These processes explain substantial variance in pain-related disability and mental health, especially among those high in activation before surgery and those low in activation at 12-months post-surgery. Our findings suggest that patients' ways of thinking about their health may be effective targets of motivational coaching, to help them become more engaged over the recovery trajectory.
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Affiliation(s)
- Richard L Skolasky
- Departments of Orthopaedic Surgery and Physical Medicine & Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline Street, Suite 5244, Baltimore, MD, 21287, USA.
| | - Joel A Finkelstein
- Department of Surgery, University of Toronto, Toronto, Canada
- Division of Orthopedic Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
- Division of Spine Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
| | - Carolyn E Schwartz
- DeltaQuest Foundation Inc, Concord, MA, USA
- Departments of Medicine and Orthopaedic Surgery, Tufts University Medical School, Boston, MA, USA
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Yuan S, Wang A, Fan N, Du P, Wang T, Li J, Zhu W, Zang L. Recompression after percutaneous transforaminal endoscopic decompression for degenerative lumbar spinal stenosis: risk factors and outcomes of two different reoperation procedures. Front Surg 2024; 11:1392215. [PMID: 38978988 PMCID: PMC11228264 DOI: 10.3389/fsurg.2024.1392215] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2024] [Accepted: 06/10/2024] [Indexed: 07/10/2024] Open
Abstract
Purpose To determine the risk factors for recompression after percutaneous transforaminal endoscopic decompression (PTED) for the treatment of degenerative lumbar spinal stenosis (DLSS) and compare the outcomes of PTED and posterior lumbar interbody fusion (PLIF) as revision surgery. Methods We retrospectively evaluated 820 consecutive DLSS patients who underwent PTED at our institution. 26 patients developed postoperative recompression and underwent reoperation. In total, 208 patients with satisfactory clinical outcomes were enrolled in the control group. The demographic and imaging data of each patient were recorded. Univariate and multivariate analyses were performed to assess risk factors for recompression. Additionally, patients with recompression were divided into PTED and PLIF groups according to the reoperation procedure. The clinical outcomes of the two groups were compared using independent-sample t-tests. Results The grade of surgical-level disc degeneration [odds ratio (OR): 2.551, p = 0.045] and the number of disc degeneration levels (OR: 11.985, p < 0.001) were independent risk factors for recompression after PTED. There was no significant difference in the visual analog score (VAS) and Oswestry disability index (ODI) two weeks postoperatively between the PTED and PLIF groups for surgical treatment. However, the mean VAS of back pain (14.1 vs. 20.5, p = 0.016) and ODI (16.0 vs. 21.8, p = 0.016) of patients in the PLIF group were smaller than those in the PTED group at the final follow-up. Conclusion More severe degeneration and degenerated levels indicate a higher recompression rate after PTED. Although both PTED and PLIF could achieve immediate relief postoperatively in the treatment of recompression, the final follow-up results showed that the outcome of PLIF appeared better than that of PTED.
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Affiliation(s)
- Shuo Yuan
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
| | - Aobo Wang
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
| | - Ning Fan
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
| | - Peng Du
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
| | - Tianyi Wang
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
| | - Jian Li
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
| | - Wenyi Zhu
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
| | - Lei Zang
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
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Fedorchuk CA, Fedorchuk CG, Lightstone DF. Improvement in Pain, Quality of Life, and Urinary Dysfunction following Correction of Lumbar Lordosis and Reduction in Lumbar Spondylolistheses Using Chiropractic BioPhysics ® Structural Spinal Rehabilitation: A Case Series with >1-Year Long-Term Follow-Up Exams. J Clin Med 2024; 13:2024. [PMID: 38610790 PMCID: PMC11012333 DOI: 10.3390/jcm13072024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2024] [Revised: 03/24/2024] [Accepted: 03/27/2024] [Indexed: 04/14/2024] Open
Abstract
(1) Background: Lumbar spondylolisthesis affects ~20% of the US population and causes spine-related pain and disability. (2) Methods: This series reports on three patients (two females and one male) aged 68-71 years showing improvements in back pain, quality of life (QOL), and urinary dysfunction following correction of lumbar spondylolistheses using CBP® spinal rehabilitation. Pre-treatment radiographs showed lumbar hyperlordosis (-49.6°, ideal is -40°) and anterolisthesis (14.5 mm, ideal is 0 mm). Pre-treatment patient-reported outcome measures (PROMs) included a numeric rating scale (NRS) for back pain (7.3/10, ideal is 0), urinary urgency (8/10, ideal is 0), and SF-36 physical (PCS) and mental component score (MCS) (29.8 and 46.6, ideal is 46.8 and 52.8). Patients underwent 2-3 CBP® sessions per week to correct lumbar hyperlordosis and lumbar anterolistheses. (3) Results: Post-treatment radiographs showed improvements in lumbar curvature (-42.8°) and anterolisthesis (4.2 mm). Post-treatment PROMs showed improvements in NRS for back pain (1/10), urinary urgency (2.3/10), and SF-36 PCS and MCS (50.2 and 57.7). Long-term follow-up radiographs and PROMs showed maintained improvements. (4) Conclusions: This series documents the first-recorded long-term corrections of lumbar spondylolisthesis and concomitant improvements in back pain, urinary urgency, and QOL using CBP®. This series provides evidence for CBP® as a non-surgical approach to lumbar spinal rehabilitation and the possible impacts of spinal alignment on pain, urinary dysfunction, and QOL.
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Affiliation(s)
| | | | - Douglas F. Lightstone
- Institute of Spinal Health and Performance, Cumming, GA 30041, USA; (C.A.F.); (C.G.F.)
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10
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Razzouk J, Cheng D, Carter D, Mehta S, Ramos O, Cheng W. Clinical and Radiographic Outcomes of Anterior Lumbar Interbody Fusion With Anterior Plate Fixation. Cureus 2024; 16:e55139. [PMID: 38558573 PMCID: PMC10979760 DOI: 10.7759/cureus.55139] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/28/2024] [Indexed: 04/04/2024] Open
Abstract
BACKGROUND Reports on the outcomes following instrumented anterior lumbar interbody fusion (ALIF) with anterior plate fixation are limited. The aim of this study was to assess the clinical and radiographic outcomes of patients undergoing ALIF with anterior plate fixation. Methods: Medical records and radiographic imaging were reviewed for 100 patients who received ALIF with anterior plate fixation between 2008 to 2021 and completed at least one year of follow-up and postoperative imaging. Prospectively collected patient data included indication for surgery, BMI, age, number and location of levels treated, complications, reoperation rates, fusion rate, and measurements of global lordosis, disc space height, and segmental angulation. Results: A total of 100 patients were included in this study. The mean length of follow-up was 81.37 months. Changes in preoperative-to-postoperative Oswestry Disability Index (ODI) and Visual Analog Score (VAS) demonstrated improvements of 30.86% and 18.56%, respectively. Major vascular injuries occurred in 3% of the cases. A hardware failure rate of 5% was observed. The reoperation rate was 10%. The radiographic fusion rate derived from computed tomography (CT) and plain film was 95.45% and 88.87%, respectively. Postoperative global lordosis demonstrated a 6.08% increase. Postoperative segmental angulation measurements increased by 57.74%. No statistically significant differences in clinical or radiographic outcomes were observed based on the spine level of fusion or the number of fusions performed. Conclusions: ALIF with anterior plate fixation achieved an adequate fusion rate with improvements in ODI and VAS scores meeting minimal clinically important difference thresholds. Postoperative disc space heights demonstrated significant improvements compared to preoperative measurements.
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Affiliation(s)
- Jacob Razzouk
- Orthopaedic Surgery, School of Medicine, Loma Linda University, Loma Linda, USA
| | - Daniel Cheng
- Biological Sciences, University of Southern California, Los Angeles, USA
| | - Davis Carter
- Orthopaedic Surgery, School of Medicine, Loma Linda University, Loma Linda, USA
| | - Shaurya Mehta
- Orthopaedics, School of Medicine, University of California Riverside, Riverside, USA
| | - Omar Ramos
- Spine Surgery, Twin Cities Spine Center, Minneapolis, USA
| | - Wayne Cheng
- Orthopaedic Surgery, Jerry L. Pettis VA Medical Center, Loma Linda, USA
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11
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Cho SS, Farber SH, DiDomenico JD, Teng CW, Park MT, Chang SW, Snyder LA, Mirzadeh Z, Uribe JS, Turner JD. Radiographic and Clinical Outcomes After Stand-Alone Anterior Lumbar Interbody Fusion for Symptomatic L5-S1 Retrolisthesis. Oper Neurosurg (Hagerstown) 2023:01787389-990000000-00979. [PMID: 38038471 DOI: 10.1227/ons.0000000000001001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/10/2023] [Accepted: 10/06/2023] [Indexed: 12/02/2023] Open
Abstract
BACKGROUND AND OBJECTIVES Degenerative lumbar spondylolisthesis is associated with significant pain and disability. The literature on the treatment options and clinical outcomes for lumbar anterolisthesis is robust, but very few reports specifically evaluate lumbar retrolisthesis. This study investigated surgical outcomes for symptomatic L5-S1 retrolisthesis treated with stand-alone L5-S1 anterior lumbar interbody fusion (ALIF). METHODS All patients with symptomatic L5-S1 retrolisthesis treated with stand-alone L5-S1 ALIF at a single institution over a 7-year period were identified. Exhaustive nonoperative management had failed for all patients. Patients with previous lumbar fusion were excluded. Preoperative and postoperative radiographic images and patient-reported outcome measures for 20 patients (14 males and 6 females; mean [SD] age, 50.3 [13.7] years) were analyzed. RESULTS The mean (SD) follow-up was 43.0 (23.7) months (range, 12.1-102.5 months). Patients experienced postoperative improvements in L5-S1 retrolisthesis (P = .048), L5-S1 disk height and angle (P < .001), L5 foraminal height (P < .001), L5-S1 lordosis (P < .001), and lumbar lordosis (P = .01). There were no significant changes in spinopelvic parameters. At the most recent follow-up, minimal clinically important differences in Oswestry Disability Index score, 36-Item Short-Form Survey (SF-36), and numerical rating scale score for leg pain were achieved in 11 of 20 (55%), 7 of 14 (50%), and 7 of 13 (54%) patients, respectively. All patients demonstrated fusion with no graft subsidence at up to 32 months. No patient experienced intraoperative complications, was readmitted, or required a subsequent posterior decompression or fusion because of refractory symptoms. CONCLUSION In our cohort, stand-alone L5-S1 ALIF was associated with radiographic and clinical improvement in patients with symptomatic L5-S1 retrolisthesis.
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Affiliation(s)
- Steve S Cho
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - S Harrison Farber
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - Joseph D DiDomenico
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - Clare W Teng
- Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Marian T Park
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - Steve W Chang
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - Laura A Snyder
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - Zaman Mirzadeh
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - Juan S Uribe
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
| | - Jay D Turner
- Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
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Issa TZ, Lee Y, Toci GR, Lambrechts MJ, Kalra A, Pipa D, Canseco JA, Hilibrand AS, Vaccaro AR, Schroeder GD, Kepler CK. The role of socioeconomic factors as barriers to patient reported outcome measure completion following lumbar spine fusion. Spine J 2023; 23:1531-1539. [PMID: 37209966 DOI: 10.1016/j.spinee.2023.05.003] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2023] [Revised: 04/19/2023] [Accepted: 05/02/2023] [Indexed: 05/22/2023]
Abstract
BACKGROUND CONTEXT Although incorporating patient reported outcomes (PROMs) into practice allows healthcare systems to evaluate the value of care provided, research and policy reflecting PROMs can only be valid if they represent all patients. Few studies have evaluated socioeconomic barriers to PROM completion, and none have done so in a spine patient population. PURPOSE To identify patient barriers to PROM completion one year following lumbar spine fusion. STUDY DESIGN/SETTING Retrospective single-institution cohort study. PATIENT SAMPLE A total of 2,984 patients undergoing lumbar fusion between 2014 and 2020 OUTCOME MEASURES: Completion of Mental Component Score (MCS-12) and Physical Component Score (PCS-12) of Short Form-12 questionnaire 1 year postoperatively. METHODS A retrospective review was conducted of all patients undergoing 1-3-level lumbar fusion at a single urban tertiary center. PROMs were queried from our prospectively managed electronic outcomes database. Patients were considered to have complete PROMs if 1-year outcomes were available. Community-level characteristics were collected from patients' zip codes using the Economic Innovation Group Distressed Communities Index. Bivariate analyses were performed to assess factors associated with PROM incompletion along with multivariate logistic regression to control for confounders. RESULTS A total of 1,968 (66.0%) had incomplete 1-year PROMs. Patients with incomplete PROMs were more likely to be Black (14.5% vs 9.3%, p<.001), Hispanic (2.9% vs 1.6%, p=.027), reside in a distressed community (14.7% vs 8.5%, p<.001), and be active smokers (22.4% vs 15.5%, p<.001). On multivariate regression, Black race (OR: 1.46, p=.014, Hispanic ethnicity (OR: 2.19, p=.027), distressed community status (OR: 1.47, p=.024), workers' compensation status (OR: 2.82, p=.001), and active smoking (OR:1.31, p=.034) all were independently associated with PROM incompletion. Surgical characteristics, including primary surgeon, revision status, approach, and levels fused were not associated with PROM incompletion. CONCLUSIONS Social determinants of health impact completion of PROMs. Patients completing PROMs are overwhelmingly White, non-Hispanic, and reside in wealthier communities. Efforts should be taken to provide better education regarding PROMs and ensure closer follow-up of certain subgroups of patients to avoid furthering disparities in PROM research.
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Affiliation(s)
- Tariq Z Issa
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA; Feinberg School of Medicine, Northwestern University, 420 E Superior St, Chicago, IL 60611, USA.
| | - Yunsoo Lee
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Gregory R Toci
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Mark J Lambrechts
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Andrew Kalra
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - David Pipa
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Jose A Canseco
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Alan S Hilibrand
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Alexander R Vaccaro
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Gregory D Schroeder
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
| | - Christopher K Kepler
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107, USA
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Kim D, Kim ES, Lee YJ, Lee JY, Park KS, Jung SY, Yang C, Han CH, Ha IH. A Pilot Study for Effectiveness of Non-Pharmacological versus Pharmacological Treatment Strategies for Lumbar Disc Herniation: A Pragmatic Randomized Controlled Trial. J Pain Res 2023; 16:3197-3216. [PMID: 37744184 PMCID: PMC10516209 DOI: 10.2147/jpr.s421148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2023] [Accepted: 08/12/2023] [Indexed: 09/26/2023] Open
Abstract
Purpose We aimed to compare the efficacy, safety, and cost-effectiveness of non-pharmacological- and pharmacological treatment strategies for Lumbar disc herniation (LDH) in pragmatic clinical settings. Patients and Methods This study was a pilot, two-armed, parallel pragmatic randomized controlled trial. Thirty patients aged 19-70 years with a numeric rating scale (NRS) score ≥5 for sciatica and confirmed LDH on magnetic resonance imaging (MRI) were included. Participants were assigned in a 1:1 ratio to non-pharmacological (non-Phm) or pharmacological (Phm) treatment group. They were treated for 8 weeks and a total follow-up period was 26 weeks after randomization. Non-Phm treatment included acupuncture, spinal manual therapy, etc., Phm included medication, injection, nerve block, etc., The primary outcome was a numeric rating scale (NRS) of radiating leg pain. NRS for low back pain, Oswestry disability index, visual analog scale, Fear-Avoidance Beliefs Questionnaire, patient global impression of change, Short Form-12 Health Survey, version 2, 5-level European Quality of Life-5 dimensions (EQ-5D) were also measured. Linear mixed model was used to evaluated the difference in change of outcomes from baseline between two groups. An economic evaluation was conducted using incremental cost-effectiveness ratios. Results There was no significant difference between the two groups in the intervention period, but non-Phm group showed significantly greater degree of improvement in follow-up of Week 14. Difference in the NRS for sciatica and ODI were 1.65 (95% CI 0.59 to 2.71, p=0.003) and 8.67 (95% CI 1.37 to 15.98, p=0.21), respectively in Week 14. The quality-adjusted life year (QALY) value calculated by EQ-5D and Short Form-6 Dimension were 0.006 (95% CI -0.012 to 0.024, p=0.472) and 0.015 (95% CI -0.008 to 0.038, p=0.195) higher in non-Phm group than in Phm group. The cost was lower in non-Phm group than in Phm group (Difference: -682, 95% CI -3349 to 1699, p=0.563). Conclusion We confirmed that the non-Phm treatment could be more cost-effective treatments than Phm treatments and feasibility of a large-scale of main study in future.
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Affiliation(s)
- Doori Kim
- Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, 06110, Republic of Korea
| | - Eun-San Kim
- Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, 06110, Republic of Korea
| | - Yoon Jae Lee
- Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, 06110, Republic of Korea
| | - Jee Young Lee
- Department of Korean Internal Medicine, Integrative Cancer Center, Cha Ilsan Medical Center, Goyang-si, Gyeonggi-do, Republic of Korea
| | - Kyong Sun Park
- Jaseng Hospital of Korean Medicine, Seoul, 06110, Republic of Korea
| | - So Young Jung
- Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea
| | - Changsop Yang
- Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
| | - Chang-Hyun Han
- Korean Convergence Medical Science, University of Science & Technology (UST), School of Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea
- KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea
| | - In-Hyuk Ha
- Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, 06110, Republic of Korea
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Power JD, Perruccio AV, Canizares M, McIntosh G, Abraham E, Attabib N, Bailey CS, Charest-Morin R, Dea N, Finkelstein J, Fisher C, Glennie RA, Hall H, Johnson MG, Kelly AM, Kingwell S, Manson N, Nataraj A, Paquet J, Singh S, Soroceanu A, Thomas KC, Weber MH, Rampersaud YR. Determining minimal clinically important difference estimates following surgery for degenerative conditions of the lumbar spine: analysis of the Canadian Spine Outcomes and Research Network (CSORN) registry. Spine J 2023; 23:1323-1333. [PMID: 37160168 DOI: 10.1016/j.spinee.2023.05.001] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/06/2022] [Revised: 04/24/2023] [Accepted: 05/02/2023] [Indexed: 05/11/2023]
Abstract
BACKGROUND CONTEXT There is significant variability in minimal clinically important difference (MCID) criteria for lumbar spine surgery that suggests population and primary pathology specific thresholds may be required to help determine surgical success when using patient reported outcome measures (PROMs). PURPOSE The purpose of this study was to estimate MCID thresholds for 3 commonly used PROMs after surgical intervention for each of 4 common lumbar spine pathologies. STUDY DESIGN/SETTING Observational longitudinal study of patients from the Canadian Spine Outcomes and Research Network (CSORN) national registry. PATIENT SAMPLE Patients undergoing surgery from 2015 to 2018 for lumbar spinal stenosis (LSS; n = 856), degenerative spondylolisthesis (DS; n = 591), disc herniation (DH; n = 520) or degenerative disc disease (DDD n = 185) were included. OUTCOME MEASURES PROMs were collected presurgery and 1-year postsurgery: the Oswestry Disability Index (ODI), and back and leg Numeric Pain Rating Scales (NPRS). At 1-year, patients reported whether they were 'Much better'/'Better'/'Same'/'Worse'/'Much worse' compared to before their surgery. Responses to this item were used as the anchor in analyses to determine surgical MCIDs for benefit ('Much better'/'Better') and substantial benefit ('Much better'). METHODS MCIDs for absolute and percentage change for each of the 3 PROMs were estimated using a receiving operating curve (ROC) approach, with maximization of Youden's index as primary criterion. Area under the curve (AUC) estimates, sensitivity, specificity and correct classification rates were determined. All analyses were conducted separately by pathology group. RESULTS MCIDs for ODI change ranged from -10.0 (DDD) to -16.9 (DH) for benefit, and -13.8 (LSS) to -22.0 (DS,DH) for substantial benefit. MCID for back and leg NPRS change were -2 to -3 for each group for benefit and -4.0 for substantial benefit for all groups on back NPRS. MCID estimates for percentage change varied by PROM and pathology group, ranging from -11.1% (ODI for DDD) to -50.0% (leg NPRS for DH) for benefit and from -40.0% (ODI for DDD) to -66.6% (leg NPRS for DH) for substantial benefit. Correct classification rates for all MCID thresholds ranged from 71% to 89% and were relatively lower for absolute vs percent change for those with high or low presurgical scores. CONCLUSIONS Our findings suggest that the use of generic MCID thresholds across pathologies in lumbar spine surgery is not recommended. For patients with relatively low or high presurgery PROM scores, MCIDs based on percentage change, rather than absolute change, appear generally preferable. These findings have applicability in clinical and research settings, and are important for future surgical prognostic work.
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Affiliation(s)
- J Denise Power
- Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, 399 Bathurst St, Toronto, Ontario, M5T 2S8, Canada
| | - Anthony V Perruccio
- Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, 399 Bathurst St, Toronto, Ontario, M5T 2S8, Canada; Orthopaedics, Department of Surgery, University of Toronto, 149 College St, Toronto, Ontario, M5T 1P5, Canada; Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, 155 College St 4(th) floor, Toronto, Ontario, M5T 3M6, Canada
| | - Mayilee Canizares
- Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, 399 Bathurst St, Toronto, Ontario, M5T 2S8, Canada
| | - Greg McIntosh
- Canadian Spine Outcomes and Research Network, 10 Armstrong Cresent, Markdale, Ontario N0C 1H0, Canada
| | - Edward Abraham
- Canada East Spine Center and Horizon Health Network, 400 University Avenue, 3C South, Saint John, New Brunswick, E2L 4L4, Canada
| | - Najmedden Attabib
- Canada East Spine Centre, Division of Neurosurgery, Zone 2, Horizon Health Network, 400 University Avenue, 3B North, Saint John, New Brunswick E2L 4L4, Canada
| | - Christopher S Bailey
- London Health Science Centre Combined Orthopaedic and Neurosurgery Spine Program, Schulich School of Medicine, Western University, 1151 Richmond Street, London, Ontario N6A 5C1, Canada
| | - Raphaële Charest-Morin
- Combined Neurosurgery and Orthopaedic Spine Program, University of British Columbia, 5959 Student Union Blvd, Vancouver, British Columbia V6T 1K2, Canada
| | - Nicholas Dea
- Combined Neurosurgery and Orthopaedic Spine Program, University of British Columbia, 5959 Student Union Blvd, Vancouver, British Columbia V6T 1K2, Canada
| | - Joel Finkelstein
- Spine Program, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, Ontario M4N 3M5, Canada
| | - Charles Fisher
- Combined Neurosurgery and Orthopaedic Spine Program, University of British Columbia, 5959 Student Union Blvd, Vancouver, British Columbia V6T 1K2, Canada
| | - R Andrew Glennie
- Department of Surgery, Division of Orthopedics, Dalhousie University, 6230 Coburg Rd, Halifax, Nova Scotia B3H 4J5, Canada
| | - Hamilton Hall
- Department of Surgery, University of Toronto, 149 College Street, Room 508-A, Toronto, Ontario M5T 1P5, Canada
| | - Michael G Johnson
- Winnipeg Spine Program Health Sciences Centre, University of Manitoba, 820 Sherbrook Street, Winnipeg, Manitoba R3A 1R9, Canada
| | - Adrienne M Kelly
- Sault Area Hospital, Northern Ontario School of Medicine, 750 Great Northern Rd, Sault Ste. Marie, Ontario P6B 0A8, Canada
| | - Stephen Kingwell
- Division of Orthopaedic Surgery, University of Ottawa, 145 Jean-Jacques-Lussier Private, Ottawa, Ontario K1N 6N5, Canada
| | - Neil Manson
- Canada East Spine Center and Horizon Health Network, 400 University Avenue, 3C South, Saint John, New Brunswick, E2L 4L4, Canada
| | - Andrew Nataraj
- Division of Neurosurgery, University of Alberta, 8440 112 St NW, Edmonton, Alberta T6G 2B7, Canada
| | - Jérôme Paquet
- Hôpital de L'Enfant-Jésus, Laval University, 401 18E Rue, Quebec City, Quebec G1J 1Z4, Canada
| | - Supriya Singh
- London Health Science Centre Combined Orthopaedic and Neurosurgery Spine Program, Schulich School of Medicine, Western University, 1151 Richmond Street, London, Ontario N6A 5C1, Canada
| | - Alex Soroceanu
- University of Calgary Spine Program, University of Calgary, 2500 University Dr, NW, Calgary, Alberta T2N 1N4, Canada
| | - Kenneth C Thomas
- University of Calgary Spine Program, University of Calgary, 2500 University Dr, NW, Calgary, Alberta T2N 1N4, Canada
| | - Michael H Weber
- Division of Orthopaedics, McGill University Health Centre, 3650 Rue Saint-Urbain Bureau K 124, Montreal, Quebec H2X 2P4, Canada
| | - Y Raja Rampersaud
- Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, 399 Bathurst St, Toronto, Ontario, M5T 2S8, Canada; Orthopaedics, Department of Surgery, University of Toronto, 149 College St, Toronto, Ontario, M5T 1P5, Canada.
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15
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Grin A, Lvov I, Talypov A, Smirnov V, Kordonskiy A, Lebedev V, Zuev A, Senko I, Pogonchenkova I, Krylov V. Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial. Trials 2023; 24:451. [PMID: 37430281 DOI: 10.1186/s13063-023-07486-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/26/2023] [Accepted: 06/29/2023] [Indexed: 07/12/2023] Open
Abstract
BACKGROUND The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ago focused on this problem. The key purpose of the current trial is to compare the long-term clinical results of the two surgical methods (decompression vs. decompression and fusion) in patients with single-level lumbar stenosis. METHODS This study is focused on the non-inferior clinical results of decompression compared with the standard fusion procedure. In the decompression group, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and corresponding parts of the vertebral arch are to be preserved intact. In the fusion group, decompression is to be supplemented with transforaminal interbody fusion. Participants meeting the inclusion criteria will be randomly divided into two equal groups (1:1), depending on the surgical method. The final analysis will include 86 patients (43 per group). The primary endpoint is Oswestry Disability Index dynamics at the end of the 24-month follow-up compared to the baseline level. Secondary outcomes included those estimated using the SF-36 scale, EQ-5D-5L, and psychological scales. Additional parameters will include sagittal balance of the spine, fusion results, total cost of surgery, and hospital stay followed by two-year treatment. Follow-up examinations will be performed at 3, 6, 12, and 24 months DISCUSSION: Authors suggest that this study will improve the evidence for application of various surgical techniques for lumbar spine stenosis surgery and verify the existing protocol for surgical management. TRIAL REGISTRATION ClinicalTrials.gov NCT05273879 . Registered on March 10, 2022.
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Affiliation(s)
- Andrey Grin
- Sklifosovsky Research Institute for Emergency Medicine, Moscow, Russia
| | - Ivan Lvov
- Sklifosovsky Research Institute for Emergency Medicine, Moscow, Russia.
| | - Aleksandr Talypov
- Sklifosovsky Research Institute for Emergency Medicine, Moscow, Russia
| | - Vladimir Smirnov
- Sklifosovsky Research Institute for Emergency Medicine, Moscow, Russia
| | - Anton Kordonskiy
- Sklifosovsky Research Institute for Emergency Medicine, Moscow, Russia
| | - Valeriy Lebedev
- Pirogov National Medical and Surgical Center, Moscow, Russia
| | - Andrey Zuev
- Pirogov National Medical and Surgical Center, Moscow, Russia
| | - Ilya Senko
- Federal State Budgetary Institution "Federal Center for Brain and Neurotechnologies" FMBA, Moscow, Russia
| | - Iren Pogonchenkova
- Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine, Moscow, Russia
| | - Vladimir Krylov
- Sklifosovsky Research Institute for Emergency Medicine, Moscow, Russia
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16
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Khashan M, Ofir D, Hochberg U, Schermann H, Regev GJ, Lidar Z, Salame K. Does Tobacco Smoking Affect the Postoperative Outcome of MIS Lumbar Decompression Surgery? J Clin Med 2023; 12:jcm12093292. [PMID: 37176733 PMCID: PMC10179248 DOI: 10.3390/jcm12093292] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2023] [Revised: 04/27/2023] [Accepted: 05/03/2023] [Indexed: 05/15/2023] Open
Abstract
BACKGROUND Tobacco smoking is a major cause of morbidity and mortality worldwide. Several authors reported a significant negative impact of smoking on the outcome of spinal surgeries. However, comparative studies on the effect of smoking on the outcome of minimally invasive (MIS) spinal decompression are rare with conflicting results. In this study, we aimed to evaluate clinical outcomes and postoperative complications following MIS decompression in current and former smoking patients compared to those of non-smoking patients. METHODS We used our prospectively collected database to retrospectively analyse the records of 188 consecutive patients treated with MIS lumbar decompression at our institution between November 2013 and July 2017. Patients were divided into groups of smokers (S), previous smokers (PS) and non-smokers (N). The S group and the PS group comprised 31 and 40 patients, respectively. The N group included 117 patients. The outcome measures included perioperative complications, revision surgery and length of stay. Patient-reported outcome measures included a visual analogue scale (VAS) for back pain and leg pain, as well as the Oswestry disability index (ODI) for evaluating functional outcomes. RESULTS Demographic variables, comorbidity and other preoperative variables were comparable between the three groups. A comparison of perioperative complications and revision surgery rates showed no significant difference between the groups. All groups showed significant improvement in their ODI and VAS scores at 12 and 24 months following surgery. As shown by a multivariate analysis, current smokers had lower chances of improvement, exceeding the minimal clinical important difference (MCID) in ODI and VAS for leg pain at 12 months but not 24 months postoperatively. CONCLUSIONS Our findings show that except for a possible delay in improvement in leg pain and disability, tobacco smoking has no substantial adverse impact on complications and revision rates following MIS spinal decompressions.
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Affiliation(s)
- Morsi Khashan
- Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6423906, Israel
| | - Dror Ofir
- Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6423906, Israel
| | - Uri Hochberg
- Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6423906, Israel
| | - Haggai Schermann
- Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6423906, Israel
| | - Gilad J Regev
- Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6423906, Israel
| | - Zvi Lidar
- Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6423906, Israel
| | - Khalil Salame
- Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6423906, Israel
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17
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Mittal S, Sudhakar PV, Ahuja K, Ifthekar S, Yadav G, Sinha S, Goyal N, Verma V, Sarkar B, Kandwal P. Deformity Correction with Interbody Fusion Using Lateral versus Posterior Approach in Adult Degenerative Scoliosis: A Systematic Review and Observational Meta-analysis. Asian Spine J 2023; 17:431-451. [PMID: 36642969 PMCID: PMC10151641 DOI: 10.31616/asj.2022.0040] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2022] [Revised: 03/21/2022] [Accepted: 03/22/2022] [Indexed: 01/17/2023] Open
Abstract
This study was designed to systematically review and meta-analyze the functional and radiological outcomes between lateral and posterior approaches in adult degenerative scoliosis (ADS). Both lateral (lumbar, extreme, and oblique) and posterior interbody fusion (posterior lumbar and transforaminal) are used for deformity correction in patients with ADS with unclear comparison in this cohort of patients in the existing literature. A literature search using three electronic databases was performed to identify studies that reported outcomes of lateral (group L) and posterior interbody fusion (group P) in patients with ADS with curves of 10°-40°. Group P was further subdivided into minimally invasive surgery (MIS-P) and open posterior (Op-P) subgroups. Data on functional, radiological, and operative outcomes, length of hospital stay (LOHS), fusion rates, and complications were extracted and meta-analyzed using the random-effects model. A total of 18 studies (732 patients) met the inclusion criteria. No significant difference was found in functional and radiological outcomes between the two groups on data pooling. Total operative time in the MIS-P subgroup was less than that of group L (233.86 minutes vs. 401 minutes, p <0.05). The total blood loss in group L was less than that in the Op-P subgroup(477 mL vs. 1,325.6 mL, p <0.05). Group L had significantly less LOHS than the Op-P subgroup (4.15 days vs. 13.5 days, p <0.05). No significant difference was seen in fusion rates, but complications were seen except for transient sensorimotor weakness (group L: 24.3%, group P: 5.6%; p <0.05). Complications, such as postoperative thigh pain (7.7%), visceral injuries (2%), and retrograde ejaculation (3.7%), were seen only in group L while adjacent segment degeneration was seen only in group P (8.6%). Lateral approach has an advantage in blood loss and LOHS over the Op-P subgroup. The MIS-P subgroup has less operative time than group L, but with comparable blood loss and LOHS. No significant difference was found in functional, radiological, fusion rates, pseudoarthrosis, and complications, except for transient sensorimotor deficits. Few complications were approach-specific in each group.
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Affiliation(s)
- Samarth Mittal
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | | | - Kaustubh Ahuja
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | - Syed Ifthekar
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | - Gagandeep Yadav
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | - Shivendra Sinha
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | - Nikhil Goyal
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | - Vishal Verma
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | - Bhaskar Sarkar
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
| | - Pankaj Kandwal
- Department of Orthopaedics, All India Institute of Medical Sciences Rishikesh, Rishikesh, India
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18
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Dandurand C, Mashayekhi MS, McIntosh G, Singh S, Paquet J, Chaudhry H, Abraham E, Bailey CS, Weber MH, Johnson MG, Nataraj A, Attabib N, Kelly A, Hall H, Rampersaud YR, Manson N, Phan P, Thomas K, Fisher C, Charest-Morin R, Soroceanu A, LaRue B, Dea N. Cost consequence analysis of waiting for lumbar disc herniation surgery. Sci Rep 2023; 13:4519. [PMID: 36934112 PMCID: PMC10024748 DOI: 10.1038/s41598-023-31029-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2022] [Accepted: 03/06/2023] [Indexed: 03/20/2023] Open
Abstract
The economic repercussions of waiting for lumbar disc surgery have not been well studied. The primary goal of this study was to perform a cost-consequence analysis of patients receiving early vs late surgery for symptomatic disc herniation from a societal perspective. Secondarily, we compared patient factors and patient-reported outcomes. This is a retrospective analysis of prospectively collected data from the CSORN registry. A cost-consequence analysis was performed where direct and indirect costs were compared, and different outcomes were listed separately. Comparisons were made on an observational cohort of patients receiving surgery less than 60 days after consent (short wait) or 60 days or more after consent (long wait). This study included 493 patients with surgery between January 2015 and October 2021 with 272 patients (55.2%) in the short wait group and 221 patients (44.8%) classified as long wait. There was no difference in proportions of patients who returned to work at 3 and 12-months. Time from surgery to return to work was similar between both groups (34.0 vs 34.9 days, p = 0.804). Time from consent to return to work was longer in the longer wait group corresponding to an additional $11,753.10 mean indirect cost per patient. The short wait group showed increased healthcare usage at 3 months with more emergency department visits (52.6% vs 25.0%, p < 0.032), more physiotherapy (84.6% vs 72.0%, p < 0.001) and more MRI (65.2% vs 41.4%, p < 0.043). This corresponded to an additional direct cost of $518.21 per patient. Secondarily, the short wait group had higher baseline NRS leg, ODI, and lower EQ5D and PCS. The long wait group had more patients with symptoms over 2 years duration (57.6% vs 34.1%, p < 0.001). A higher proportion of patients reached MCID in terms of NRS leg pain at 3-month follow up in the short wait group (84.0% vs 75.9%, p < 0.040). This cost-consequence analysis of an observational cohort showed decreased costs associated with early surgery of $11,234.89 per patient when compared to late surgery for lumbar disc herniation. The early surgery group had more severe symptoms with higher healthcare utilization. This is counterbalanced by the additional productivity loss in the long wait group, which likely have a more chronic disease. From a societal economic perspective, early surgery seems beneficial and should be promoted.
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Affiliation(s)
- Charlotte Dandurand
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Blusson Spinal Cord Center, 6th Floor, 818 West 10th Avenue, Vancouver, BC, V5Z 1M9, Canada.
| | - Mohammad Sadegh Mashayekhi
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Blusson Spinal Cord Center, 6th Floor, 818 West 10th Avenue, Vancouver, BC, V5Z 1M9, Canada
| | - Greg McIntosh
- Canadian Spine Outcomes and Research Network, Markdale, ON, Canada
| | - Supriya Singh
- London Health Science Centre Combined Neurosurgical and Orthopaedic Spine Program, Schulich School of Medicine, Western University, London, ON, Canada
| | - Jerome Paquet
- Centre de Recherche CHU de Quebec, CHU de Quebec-Universite Laval, Quebec City, QC, Canada
| | - Hasaan Chaudhry
- Sunnybrook Hospital, University of Toronto, Toronto, ON, Canada
| | - Edward Abraham
- Division of Orthopaedic Surgery, Zone 2, Horizon Health Network, Canada East Spine Centre, Saint John, NB, Canada
| | - Christopher S Bailey
- London Health Science Centre Combined Neurosurgical and Orthopaedic Spine Program, Schulich School of Medicine, Western University, London, ON, Canada
| | - Michael H Weber
- Department of Surgery, Division of Orthopaedics, Montreal General Hospital, McGill University, Montreal, QC, Canada
| | - Michael G Johnson
- Department of Surgery, Section of Orthopedics and Neurosurgery, University of Manitoba, Winnipeg, MB, Canada
| | - Andrew Nataraj
- Division of Neurosurgery, University of Alberta, Edmonton, AB, Canada
| | - Najmedden Attabib
- Division of Neurosurgery, Zone 2, Horizon Health Network, Canada East Spine Centre, Saint John, NB, Canada
| | - Adrienne Kelly
- Sault Area Hospital, Northern Ontario School of Medicine, Sault Ste Marie, ON, Canada
| | - Hamilton Hall
- Department of Surgery, University of Toronto, Toronto, ON, Canada
| | - Y Raja Rampersaud
- Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Orthopaedics, Department of Surgery, University of Toronto, Toronto, ON, Canada
| | - Neil Manson
- Division of Orthopaedic Surgery, Zone 2, Horizon Health Network, Canada East Spine Centre, Saint John, NB, Canada
| | - Philippe Phan
- Division of Orthopaedic Surgery, University of Ottawa, Ottawa Hospital, Ottawa, ON, Canada
| | - Ken Thomas
- University of Calgary Spine Program, University of Calgary, Calgary, AB, Canada
| | - Charles Fisher
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Blusson Spinal Cord Center, 6th Floor, 818 West 10th Avenue, Vancouver, BC, V5Z 1M9, Canada
| | - Raphaele Charest-Morin
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Blusson Spinal Cord Center, 6th Floor, 818 West 10th Avenue, Vancouver, BC, V5Z 1M9, Canada
| | - Alex Soroceanu
- Division of Orthopaedic Surgery, University of Ottawa, Ottawa Hospital, Ottawa, ON, Canada
| | - Bernard LaRue
- Départment de chirurgie, Faculté de Médecine et des Sciences de la Santé, Université de Sherbrooke, Sherbrooke, QC, Canada
| | - Nicolas Dea
- Combined Neurosurgical and Orthopedic Spine Program, Department of Orthopedics Surgery, University of British Columbia, Blusson Spinal Cord Center, 6th Floor, 818 West 10th Avenue, Vancouver, BC, V5Z 1M9, Canada
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19
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Leonova ON, Baikov ES, Krutko AV. Minimal clinically important difference as a method for assessing the effectiveness of spinal surgery using scales and questionnaires: non-systematic literature review. HIRURGIÂ POZVONOČNIKA (SPINE SURGERY) 2022. [DOI: 10.14531/ss2022.4.60-67] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
Objective. To analyze the literature data and to present recommendations on the use of the minimum clinically important difference (MCID) in the practice of spinal surgeon-researcher.Material and Methods. The article is a non-systematic review of the literature. A search was performed for sources, which describe the calculation and analysis of the MCID parameter on a cohort of patients with degenerative spinal diseases in the PubMed, Scopus and Web of Science databases. Further, the analysis of the literature was carried out on the application of MCID to assess the effectiveness of surgical treatment.Results. The MCID parameter is illustrated for the most common clinical scales used to assess the effectiveness of treatment in spinal surgery, with their detailed description and discussion of their benefits and drawbacks. The specific MCID values for cervical and lumbar pathologies, first of all degenerative ones, and follow-up periods, which can be used in assessing the results of the treatment, as well as in planning prospective comparative studies are presented.Conclusion. The MCID parameter is required for sample size calculation and for the analysis of treatment outcomes. The MCID reflects not just the change in the baseline indicator, but also the clinical significance for the patient.
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Affiliation(s)
- O. N. Leonova
- Priorov National Medical Research Center for Traumatology and Orthopedics
10 Priorova str., Moscow, 127299, Russia
| | - E. S. Baikov
- Priorov National Medical Research Center for Traumatology and Orthopedics
10 Priorova str., Moscow, 127299, Russia
| | - A. V. Krutko
- Priorov National Medical Research Center for Traumatology and Orthopedics
10 Priorova str., Moscow, 127299, Russia
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20
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Soliman MAR, Ruggiero N, Aguirre AO, Kuo CC, Khawar WI, Khan A, Jowdy PK, Starling RV, Mullin JP, Pollina J. Prone Transpsoas Lateral Lumbar Interbody Fusion for Degenerative Lumbar Spine Disease: Case Series With an Operative Video Using Fluoroscopy-Based Instrument Tracking Guidance. Oper Neurosurg (Hagerstown) 2022; 23:382-388. [PMID: 36227242 DOI: 10.1227/ons.0000000000000368] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2022] [Accepted: 05/26/2022] [Indexed: 11/07/2022] Open
Abstract
BACKGROUND Lateral lumbar interbody fusion has inherent limitations, such as the necessity to reposition the patient. To overcome this limitation, the prone transpsoas (PTP) approach for lateral lumbar interbody fusion has been developed. OBJECTIVE To report clinical and radiographic outcome measures of a series of patients who underwent PTP at our hospital. METHODS A retrospective chart review was conducted to identify patients who underwent PTP for degenerative lumbar spine disease between September 2019 and August 2021. A thorough analysis of clinical and radiographic outcome measures for these patients was conducted. RESULTS Our search resulted in the identification of 15 consecutive patients. Four patients were operated using the assistance of fluoroscopy-based instrument tracking. Overall, the mean follow-up duration was 11.9 ± 7.9 months. Radiographically, the PTP approach resulted in significant postoperative improvement of lumbar lordosis ( P = .03) and pelvic incidence minus lumbar lordosis ( P < .005). No significant difference was found postoperatively in other regional sagittal alignment parameters, including pelvic tilt, sacral slope, or pelvic incidence. Clinically, the patients' Oswestry Disability Indices ( P = .002) and Short Form Survey-12 Physical Scores improved significantly ( P = .01). The estimated mean blood loss for patients who underwent the PTP procedure was 137.7 ± 96.4 mL, the mean operative time was 212.5 ± 77.1 minutes, and the mean hospital stay was 2.7 ± 1.4 days. One patient each had superficial wound infection, transient paralytic ileus, transient pulmonary embolism, transient urinary retention, or required revision lumbar surgery. CONCLUSION This study demonstrates that the PTP approach is associated with significant improvement in radiographic and clinical outcomes.
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Affiliation(s)
- Mohamed A R Soliman
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
- Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
- Department of Neurosurgery, Faculty of Medicine, Cairo University, Cairo, Egypt
| | - Nicco Ruggiero
- Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
| | - Alexander O Aguirre
- Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
| | - Cathleen C Kuo
- Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
| | - Wasiq I Khawar
- Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
| | - Asham Khan
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
- Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
| | - Patrick K Jowdy
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
- Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
| | - Robert V Starling
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
- Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
| | - Jeffrey P Mullin
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
- Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
| | - John Pollina
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences at University at Buffalo, Buffalo, New York, USA
- Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
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21
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Ayling OGS, Rampersaud YR, Dandurand C, Yuan PHS, Ailon T, Dea N, McIntosh G, Christie SD, Abraham E, Bailey CS, Johnson MG, Bouchard J, Weber MH, Paquet J, Finkelstein J, Stratton A, Hall H, Manson N, Thomas K, Fisher CG. Surgical outcomes of patients who fail to reach minimal clinically important differences: comparison of minimally invasive versus open transforaminal lumbar interbody fusion. J Neurosurg Spine 2022; 37:376-383. [PMID: 35426818 DOI: 10.3171/2022.2.spine211210] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2021] [Accepted: 02/02/2022] [Indexed: 11/06/2022]
Abstract
OBJECTIVE Treatment of degenerative lumbar diseases has been shown to be clinically effective with open transforaminal lumbar interbody fusion (O-TLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Despite this, a substantial proportion of patients do not meet minimal clinically important differences (MCIDs) in patient-reported outcomes (PROs). The objectives of this study were to compare the proportions of patients who did not meet MCIDs after O-TLIF and MIS-TLIF and to determine potential clinical factors associated with failure to achieve MCID. METHODS The authors performed a retrospective analysis of consecutive patients who underwent O-TLIF or MIS-TLIF for lumbar degenerative disorders and had been prospectively enrolled in the Canadian Spine Outcomes and Research Network. The authors analyzed the Oswestry Disability Index (ODI) scores, physical and mental component summary scores of SF-12, numeric rating scale (NRS) scores for leg and back pain, and EQ-5D scores of the patients in each group who did not meet the MCID of ODI at 2 years postoperatively. RESULTS In this study, 38.8% (137 of 353) of patients in the O-TLIF cohort and 41.8% (51 of 122) of patients in the MIS-TLIF cohort did not meet the MCID of ODI at 2 years postoperatively (p = 0.59). Demographic variables and baseline PROs were similar between groups. There were improvements across the PROs of both groups through 2 years, and there were no differences in any PROs between the O-TLIF and MIS-TLIF cohorts. Multivariable logistic regression analysis demonstrated that higher baseline leg pain score (p = 0.017) and a diagnosis of spondylolisthesis (p = 0.0053) or degenerative disc disease (p = 0.022) were associated with achieving the MCID at 2 years after O-TLIF, whereas higher baseline leg pain score was associated with reaching the MCID after MIS-TLIF (p = 0.038). CONCLUSIONS Similar proportions of patients failed to reach the MCID of ODI at 2 years after O-TLIF or MIS-TLIF. Higher baseline leg pain score was predictive of achieving the MCID in both cohorts, whereas a diagnosis of spondylolisthesis or degenerative disc disease was predictive of reaching the MCID after O-TLIF. These data provide novel insights for patient counseling and suggest that either MIS-TLIF or O-TLIF does not overcome specific patient factors to mitigate clinical success or failure in terms of the intermediate-term PROs associated with 1- to 2-level lumbar fusion surgical procedures for degenerative pathologies.
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Affiliation(s)
- Oliver G S Ayling
- 1Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia
| | | | - Charlotte Dandurand
- 1Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia
| | - Po Hsiang Shawn Yuan
- 1Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia
| | - Tamir Ailon
- 1Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia
| | - Nicolas Dea
- 1Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia
| | | | - Sean D Christie
- 4Department of Surgery, Dalhousie University, Halifax, Nova Scotia
| | - Edward Abraham
- 5Department of Surgery, Canada East Spine Centre, Saint John, New Brunswick
| | | | - Michael G Johnson
- 7Departments of Orthopedics and Neurosurgery, University of Manitoba, Winnipeg, Manitoba
| | | | | | - Jerome Paquet
- 10Department of Surgery, Laval University, Quebec City, Quebec; and
| | | | | | - Hamilton Hall
- 2Department of Surgery, University of Toronto, Ontario
| | - Neil Manson
- 5Department of Surgery, Canada East Spine Centre, Saint John, New Brunswick
| | - Kenneth Thomas
- 7Departments of Orthopedics and Neurosurgery, University of Manitoba, Winnipeg, Manitoba
| | - Charles G Fisher
- 1Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia
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22
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Costa DA, Carvalho FM, Vieira NM, Falcão GGSC, Sarmento VA, Brites C, Lins-Kusterer L. Work ability and associated factors in people living with human T-cell leukemia virus type 1. Rev Soc Bras Med Trop 2022; 55:e0111. [PMID: 35946625 PMCID: PMC9344948 DOI: 10.1590/0037-8682-0111-2022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2022] [Accepted: 06/10/2022] [Indexed: 12/04/2022] Open
Abstract
Background: Infection with the human T-lymphotropic virus type 1 (HTLV-1) affects an
estimated 10-15 million people worldwide. However, knowledge of the impact
of HTLV-1 infection on work ability is lacking. This study aimed to measure
the frequency and identify factors associated with poor work ability in
patients living with HTLV-1. Methods: This cross-sectional study included 207 individuals infected with HTLV-1 who
attended the University Hospital in Salvador, Bahia, Brazil. HTLV-1
antibodies were detected in the participants’ blood by enzyme-linked
immunosorbent assay (ELISA) and confirmed by western blotting. Participants
answered a questionnaire on sociodemographic data, personal habits, clinical
data, health-related quality of life, and work ability, evaluated using the
work ability index questionnaire. A Poisson regression model with a robust
variance estimate was used to identify the factors associated with the
prevalence of poor work ability. Results: Patients mean age was 55.2, ranging from 19 to 84 years, 73.0% were females,
100% had monthly family income less than US$ 394, and 33.8% presented HTLV-1
associated myelopathy/tropical spastic paraparesis (HAM/TSP). No individual
was classified as having excellent work ability. Poor work ability
prevalence was strongly associated (prevalence ratio; 95% confidence
interval [CI]) with sedentarism (1.30; 1.03-1.65), neurological symptoms
(1.25; 1.02-1.52), and low physical (0.95; 0.94-0.96) and mental (0.98;
0.97-0.99) component summaries of health-related quality of life. Conclusions: Poor work ability among people living with HTLV-1 is associated with
sedentarism, neurologic symptoms, and low health-related quality of
life.
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Affiliation(s)
- Dayana Alves Costa
- Universidade Federal da Bahia, Programa de Pós-graduação em Medicina e Saúde, Salvador, BA, Brasil
| | | | - Nicolle Melo Vieira
- Universidade Federal da Bahia, Programa de Pós-graduação em Medicina e Saúde, Salvador, BA, Brasil
| | | | | | - Carlos Brites
- Universidade Federal da Bahia, Programa de Pós-graduação em Medicina e Saúde, Salvador, BA, Brasil
| | - Liliane Lins-Kusterer
- Universidade Federal da Bahia, Programa de Pós-graduação em Medicina e Saúde, Salvador, BA, Brasil
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23
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Kweh BTS, Tan T, Lee HQ, Hunn M, Liew S, Tee JW. Implant Removal Versus Implant Retention Following Posterior Surgical Stabilization of Thoracolumbar Burst Fractures: A Systematic Review and Meta-Analysis. Global Spine J 2022; 12:700-718. [PMID: 33926307 PMCID: PMC9109574 DOI: 10.1177/21925682211005411] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
STUDY DESIGN Systematic review and meta-analysis. OBJECTIVES To compare biomechanical and functional outcomes between implant removal and implant retention following posterior surgical fixation of thoracolumbar burst fractures. METHODS A search of the MEDLINE, EMBASE, Google Scholar and Cochrane Databases was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. RESULTS Of the 751 articles initially retrieved, 13 published articles pooling 673 patients were included. Meta-analysis revealed there was a statistically significant improvement in sagittal Cobb Angle by 16.48 degrees (9.13-23.83, p < 0.01) after surgical stabilization of thoracolumbar burst fractures. This correction decremented to 9.68 degrees (2.02-17.35, p < 0.01) but remained significant at the time of implant removal approximately 12 months later. At final follow-up, the implant removal group demonstrated a 10.13 degree loss (3.00-23.26, p = 0.13) of reduction, while the implant retention group experienced a 10.17 degree loss (1.79-22.12, p = 0.10). There was no statistically significant difference in correction loss between implant retention and removal cohorts (p = 0.97). Pooled VAS scores improved by a mean of 3.32 points (0.18 to 6.45, p = 0.04) in the combined removal group, but by only 2.50 points (-1.81 to 6.81, p = 0.26) in the retention group. Oswestry Disability Index scores also improved after implant removal by 7.80 points (2.95-12.64, p < 0.01) at 1 year and 11.10 points (5.24-16.96, p < 0.01) at final follow-up. CONCLUSIONS In younger patients with thoracolumbar burst fractures who undergo posterior surgical stabilization, planned implant removal results in superior functional outcomes without significant difference in kyphotic angle correction loss compared to implant retention.
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Affiliation(s)
- Barry Ting Sheen Kweh
- National Trauma Research
Institute, Melbourne, Victoria, Australia,Department of Neurosurgery, Royal
Melbourne Hospital, Parkville, Victoria, Melbourne,Department of Neurosurgery, The Alfred Hospital, Melbourne, Victoria, Australia,Barry Kweh, National Trauma Research
Institute, Melbourne, Victoria, Australia; Department of Neurosurgery, Royal
Melbourne Hospital, Parkville, Victoria, Melbourne; Department of Neurosurgery,
The Alfred Hospital, Melbourne, Victoria, Australia.
| | - Terence Tan
- National Trauma Research
Institute, Melbourne, Victoria, Australia,Department of Neurosurgery, The Alfred Hospital, Melbourne, Victoria, Australia
| | - Hui Qing Lee
- National Trauma Research
Institute, Melbourne, Victoria, Australia,Department of Neurosurgery, The Alfred Hospital, Melbourne, Victoria, Australia
| | - Martin Hunn
- Department of Neurosurgery, The Alfred Hospital, Melbourne, Victoria, Australia,Central Clinical School, Faculty of
Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria,
Australia
| | - Susan Liew
- Central Clinical School, Faculty of
Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria,
Australia,Department of Orthopaedics, The
Alfred Hospital, Melbourne, Victoria, Australia
| | - Jin Wee Tee
- National Trauma Research
Institute, Melbourne, Victoria, Australia,Department of Neurosurgery, The Alfred Hospital, Melbourne, Victoria, Australia,Central Clinical School, Faculty of
Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria,
Australia
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Sousa JM, Ribeiro H, Silva JL, Nogueira P, Consciência JG. Clinical outcomes, complications and fusion rates in endoscopic assisted intraforaminal lumbar interbody fusion (iLIF) versus minimally invasive transforaminal lumbar interbody fusion (MI-TLIF): systematic review and meta-analysis. Sci Rep 2022; 12:2101. [PMID: 35136081 PMCID: PMC8825843 DOI: 10.1038/s41598-022-05988-0] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2021] [Accepted: 01/20/2022] [Indexed: 12/23/2022] Open
Abstract
This meta-analysis aims to determine the clinical outcomes, complications, and fusion rates in endoscopic assisted intra-foraminal lumbar interbody fusion (iLIF) and minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) for lumbar degenerative diseases. The MEDLINE, Embase, and Cochrane Library databases were searched. The inclusion criteria were: five or more consecutive patients who underwent iLIF or MI-TLIF for lumbar degenerative diseases; description of the surgical technique; clinical outcome measures, complications and imaging assessment; minimum follow-up of 12 months. Surgical time, blood loss, and length of hospital stay were extracted. Mean outcome improvements were pooled and compared with minimal clinically important differences (MCID). Pooled and direct meta-analysis were evaluated. We identified 42 eligible studies. The iLIF group had significantly lower mean intra-operative blood loss, unstandardized mean difference (UMD) 110.61 mL (95%CI 70.43; 150.80; p value < 0.0001), and significantly decreased length of hospital stay (UMD 2.36; 95%CI 1.77; 2.94; p value < 0.0001). Visual analogue scale (VAS) back, VAS leg and Oswestry disability index (ODI) baseline to last follow-up mean improvements were statistically significant (p value < 0.0001), and clinically important for both groups (MCID VAS back > 1.16; MCID VAS leg > 1.36; MCID > 12.40). There was no significant difference in complication nor fusion rates between both cohorts. Interbody fusion using either iLIF or MI-TLIF leads to significant and clinically important improvements in clinical outcomes for lumbar degenerative diseases. Both procedures provide high rates of fusion at 12 months or later, without significant difference in complication rates. iLIF is associated with significantly less intraoperative blood loss and length of hospital stay.
Study registration: PROSPERO international prospective register of systematic reviews: Registration No. CRD42020180980, accessible at https://www.crd.york.ac.uk/prospero/ April 2020.
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Affiliation(s)
- José Miguel Sousa
- Orthopaedics Department, Centro Hospitalar Lisboa Ocidental, Estrada do Forte do Alto Duque, 1449-005, Lisbon, Portugal. .,Comprehensive Health Research Center, NOVA Medical School - Universidade NOVA de Lisboa, Campo Mártires da Pátria, 130, 1169-056, Lisbon, Portugal.
| | - Hugo Ribeiro
- Orthopaedics Department, Centro Hospitalar Lisboa Ocidental, Estrada do Forte do Alto Duque, 1449-005, Lisbon, Portugal
| | - João Luís Silva
- Orthopaedics Department, Centro Hospitalar Lisboa Ocidental, Estrada do Forte do Alto Duque, 1449-005, Lisbon, Portugal
| | - Paulo Nogueira
- Área Disciplinar Autónoma de Bioestatística (Laboratório de Biomatemática), Faculdade de Medicina, Instituto de Medicina Preventiva e Saúde Pública, Universidade de Lisboa, Avenida Professor Egas Moniz, 1649-028, Lisbon, Portugal
| | - José Guimarães Consciência
- Orthopaedics Department, Centro Hospitalar Lisboa Ocidental, Estrada do Forte do Alto Duque, 1449-005, Lisbon, Portugal.,Comprehensive Health Research Center, NOVA Medical School - Universidade NOVA de Lisboa, Campo Mártires da Pátria, 130, 1169-056, Lisbon, Portugal
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Severijns P, Overbergh T, Ackermans T, Beaucage-Gauvreau E, Brumagne S, Desloovere K, Scheys L, Moke L. The Function Assessment Scale for Spinal Deformity: Validity and Reliability of a New Clinical Scale. Spine (Phila Pa 1976) 2022; 47:E64-E72. [PMID: 34669676 DOI: 10.1097/brs.0000000000004266] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Cross-sectional study. OBJECTIVE The aim of this study was to develop and validate the Function Assessment scale for Spinal Deformity (FASD). SUMMARY OF BACKGROUND DATA Spinal malalignment impacts daily functioning. Standard evaluation of adult spinal deformity (ASD) is based on static radiography and patient-reported scores, which fail to assess functional impairments. A clinical scale, quantifying function and balance of patients with ASD, could increase our insights on the impact of ASD on functioning. METHODS To develop the FASD, 70 ASD patients and 20 controls were measured to identify the most discriminating items of the Balance Evaluation Systems Test and Trunk Control Measurement Scale. Discussions between experts on the clinical relevance of selected items led to further item reduction. The FASD's discriminative ability was established between 43 patients and 19 controls, as well as between three deformity subgroups. For its responsiveness to treatment, 10 patients were reevaluated 6 months postoperatively. Concurrent validity was assessed through correlation analysis with radiographic parameters (pelvic tilt; sagittal vertical axis [SVA]; pelvic incidence minus lumbar lordosis [PI-LL]; coronal vertical axis) and patient-reported scores [Oswestry Disability Index]; Scoliosis Research Society outcome questionnaire; Falls Efficacy Scale-International). Test-retest and interrater reliability were tested on two groups of ten patients using intraclass correlation coefficients (ICC). RESULTS Patients with ASD, mainly with sagittal malalignment, scored worse compared to controls on FASD (P < 0.001) and its subscales. No significant improvement was observed 6 months postoperatively (P = 0.758). FASD correlated significantly to all patient-reported scores and to SVA and PI-LL. Reliability between sessions (ICC = 0.97) and raters (ICC = 0.93) was excellent. Subscales also showed good to excellent reliability, except FASD 1 on "spinal mobility and balance" between sessions (ICC = 0.71). CONCLUSION FASD proved to be a valid and reliable clinical scale for evaluation of functional impairments in ASD. Objective information on function and balance might ultimately guide physiotherapeutic treatment toward improved functioning.Level of Evidence: 2.
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Affiliation(s)
- Pieter Severijns
- Institute for Orthopedic Research and Training (IORT), Department of Development and Regeneration, Faculty of Medicine, KU Leuven, Leuven, Belgium
- Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium
- Clinical Motion Analysis Laboratory (CMAL), University Hospitals Leuven, Leuven, Belgium
| | - Thomas Overbergh
- Institute for Orthopedic Research and Training (IORT), Department of Development and Regeneration, Faculty of Medicine, KU Leuven, Leuven, Belgium
| | - Thijs Ackermans
- Institute for Orthopedic Research and Training (IORT), Department of Development and Regeneration, Faculty of Medicine, KU Leuven, Leuven, Belgium
| | - Erica Beaucage-Gauvreau
- Institute for Orthopedic Research and Training (IORT), Department of Development and Regeneration, Faculty of Medicine, KU Leuven, Leuven, Belgium
| | - Simon Brumagne
- Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium
| | - Kaat Desloovere
- Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium
- Clinical Motion Analysis Laboratory (CMAL), University Hospitals Leuven, Leuven, Belgium
| | - Lennart Scheys
- Institute for Orthopedic Research and Training (IORT), Department of Development and Regeneration, Faculty of Medicine, KU Leuven, Leuven, Belgium
- Division of Orthopedics, University Hospitals Leuven, Leuven, Belgium
| | - Lieven Moke
- Institute for Orthopedic Research and Training (IORT), Department of Development and Regeneration, Faculty of Medicine, KU Leuven, Leuven, Belgium
- Division of Orthopedics, University Hospitals Leuven, Leuven, Belgium
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Soliman MAR, Khan A, Pollina J. Comparison of Prone Transpsoas and Standard Lateral Lumbar Interbody Fusion Surgery for Degenerative Lumbar Spine Disease: A Retrospective Radiographic Propensity Score-Matched Analysis. World Neurosurg 2022; 157:e11-e21. [PMID: 34464774 DOI: 10.1016/j.wneu.2021.08.097] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2021] [Revised: 08/19/2021] [Accepted: 08/20/2021] [Indexed: 10/20/2022]
Abstract
BACKGROUND Prone transpsoas lateral lumbar interbody fusion (PTP-LLIF) is a recently introduced modification to standard LLIF. To date, no study has compared the radiographic outcomes of standard LLIF and PTP-LLIF. We performed a radiographic parameter-based propensity score-matched analysis to compare postoperative clinical and radiographic outcomes between PTP-LLIF and standard LLIF for degenerative lumbar spine disease. METHODS A total of 30 consecutive patients met the inclusion criteria. The preoperative standing scoliosis radiographs were retrospectively reviewed for global and segmental sagittal alignment. Propensity score matching was calculated using the baseline radiographic parameters. One-to-one matching of patients who had undergone PTP-LLIF with those who had a similar propensity score but had undergone standard LLIF was performed to compare the radiographic (primary) and clinical (secondary) outcomes. RESULTS Propensity score matching resulted in 10 pairs of PTP-LLIF and standard LLIF patients. The PTP-LLIF group had had significantly better improvement in lumbar lordosis (P = 0.047). The difference in the improvement in pelvic incidence minus lumbar lordosis mismatch approached statistical significance for the PTP-LLIF group (P = 0.05). This led to better improvement in the short-form 12-item physical score (P = 0.03) and Oswestry disability index (P = 0.1) in the PTP-LLIF group. No significant differences were found between the 2 groups in the other clinical and radiographic outcomes. The PTP-LLIF group had a shorter operative time (P = 0.4) and hospital stay (P = 0.1), without a statistically difference, and shorter radiation exposure time (P = 0.5). The standard LLIF group had experienced less intraoperative bleeding, without a statistically significant difference (P = 0.3). The mean follow-up time was 10.2 ± 5.2 months in the PTP-LLIF group and 30.9 ± 17.2 months in the standard LLIF group (P < 0.05). CONCLUSIONS The PTP-LLIF group showed significantly better improvement in lumbar lordosis and short-form 12-item physical score.
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Affiliation(s)
- Mohamed A R Soliman
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA; Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA; Department of Neurosurgery, Faculty of Medicine, Cairo University, Cairo, Egypt
| | - Asham Khan
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA; Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA
| | - John Pollina
- Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA; Department of Neurosurgery, Buffalo General Medical Center, Kaleida Health, Buffalo, New York, USA.
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Clinical outcome following decompression and short or long instrumented fusion in lumbar degenerative spinal stenosis. A prospective case-control analysis. Clin Neurol Neurosurg 2021; 211:107038. [PMID: 34823153 DOI: 10.1016/j.clineuro.2021.107038] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2021] [Revised: 10/27/2021] [Accepted: 11/13/2021] [Indexed: 11/20/2022]
Abstract
OBJECTIVES There is limited data on the direct clinical comparison between short and long fusion following surgery for lumbar spinal stenosis. The hypothesis that regardless their baseline characteristics and morbidity, clinical outcome is similar in patients with lumbar stenosis treated with decompression plus posterior instrumented fusion in one or two versus three to five levels was tested. METHODS Subjects were divided into Group A and Group B corresponding to stenotic pathology and instrumented fusion in one or two levels and three to five levels, respectively. Primary outcome measures at one year were the change in SF-36 physical component (PCS) and Oswestry Disability Index (ODI). Secondary outcome measures included the EuroQol-5D (EQ-5D), the Visual Analog Scale (VAS), the mental component (MCS) of SF-36 scale and the Zung Self-Rating Depression Scale. RESULTS Seventy seven (77) patients were included (Group A, n = 42; Group B, n = 35). Patients in Group B were older, surgery lasted longer and intraoperative blood loss was greater than patients in Group A (p < 0.05). A significant clinical improvement was noted in both Groups on all scales (p < 0.01). Clinical outcome at one year was equally favorable in both Groups (p > 0.05). The evaluation of depression for Group A showed a significant improvement at one year (p = 0.02) compared to the preoperative status. CONCLUSIONS Older individuals are more likely to have multilevel stenosis and more co-morbidities and they were associated with longer instrumentation. However, complications are similar and clinical outcome is equally favorable compared to short instrumented fusion for fewer levels of disease.
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Stable Low-Grade Degenerative Spondylolisthesis Does Not Compromise Clinical Outcome of Minimally Invasive Tubular Decompression in Patients with Spinal Stenosis. Medicina (B Aires) 2021; 57:medicina57111270. [PMID: 34833488 PMCID: PMC8622409 DOI: 10.3390/medicina57111270] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2021] [Revised: 11/04/2021] [Accepted: 11/16/2021] [Indexed: 11/22/2022] Open
Abstract
Background and Objectives: In recent literature, the routine addition of arthrodesis to decompression for lumbar spinal stenosis (LSS) with concomitant stable low-grade degenerative spondylolisthesis remains controversial. The purpose of this study is to compare the clinical outcome, complication and re-operation rates following minimally invasive (MIS) tubular decompression without arthrodesis in patients suffering from LSS with or without concomitant stable low-grade degenerative spondylolisthesis. Materials and Methods: This study is a retrospective review of prospectively collected data. Ninety-six consecutive patients who underwent elective MIS lumbar decompression with a mean follow-up of 27.5 months were included in the study. The spondylolisthesis (S) group comprised 53 patients who suffered from LSS with stable degenerative spondylolisthesis, and the control (N) group included 43 patients suffering from LSS without spondylolisthesis. Outcome measures included complications and revision surgery rates. Pre- and post-operative visual analog scale (VAS) for both back and leg pain was analyzed, and the Oswestry Disability Index (ODI) was used to evaluate functional outcome. Results: The two groups were comparable in most demographic and preoperative variables. VAS for back and leg pain improved significantly following surgery in both groups. Both groups showed significant improvement in their ODI scores, at one and two years postoperatively. The average length of hospital stay was significantly higher in patients with spondylolisthesis (p-value< 0.01). There was no significant difference between the groups in terms of post-operative complications rates or re-operation rates. Conclusions: Our results indicate that MIS tubular decompression may be an effective and safe procedure for patients suffering from LSS, with or without degenerative stable spondylolisthesis.
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Beauchamp-Chalifour P, Flexman AM, Street JT, Fisher CG, Ailon T, Dvorak MF, Kwon BK, Paquette SJ, Dea N, Charest-Morin R. The impact of frailty on patient-reported outcomes after elective thoracolumbar degenerative spine surgery. J Neurosurg Spine 2021; 35:607-615. [PMID: 34359047 DOI: 10.3171/2021.2.spine201879] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2020] [Accepted: 02/02/2021] [Indexed: 11/06/2022]
Abstract
OBJECTIVE Frailty has been shown to be a risk factor of perioperative adverse events (AEs) in patients undergoing various types of spine surgery. However, the relationship between frailty and patient-reported outcomes (PROs) remains unclear. The primary objective of this study was to determine the impact of frailty on PROs of patients who underwent surgery for thoracolumbar degenerative conditions. The secondary objective was to determine the associations among frailty, baseline PROs, and perioperative AEs. METHODS This was a retrospective study of a prospective cohort of patients older than 55 years who underwent surgery between 2012 and 2018. Data and PROs (collected with EQ-5D, Physical Component Summary [PCS] and Mental Component Summary [MCS] of SF-12, Oswestry Disability Index [ODI], and numeric rating scales [NRS] for back pain and leg pain) of patients treated at a single academic center were extracted from the Canadian Spine Outcomes and Research Network registry. Frailty was calculated using the modified frailty index (mFI), and patients were classified as frail, prefrail, and nonfrail. A generalized estimating equation (GEE) regression model was used to assess the association between baseline frailty status and PRO measures at 3 and 12 months. RESULTS In total, 293 patients with a mean ± SD age of 67 ± 7 years were included. Of these, 22% (n = 65) were frail, 59% (n = 172) were prefrail, and 19% (n = 56) were nonfrail. At baseline, the three frailty groups had similar PROs, except PCS (p = 0.003) and ODI (p = 0.02) were worse in the frail group. A greater proportion of frail patients experienced major AEs than nonfrail patients (p < 0.0001). However, despite the increased incidence of AEs, there was no association between frailty and postoperative PROs (scores on EQ-5D, PCS and MCS, ODI, and back-pain and leg-pain NRS) at 3 and 12 months (p ≥ 0.05). In general, PROs improved at 3 and 12 months (with most patients reaching the minimum clinically important difference for all PROs). CONCLUSIONS Although frailty predicted postoperative AEs, mFI did not predict PROs of patients older than 55 years with degenerative thoracolumbar spine after spine surgery.
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Affiliation(s)
| | - Alana M Flexman
- 2Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia; and
| | - John T Street
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
| | - Charles G Fisher
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
| | - Tamir Ailon
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
| | - Marcel F Dvorak
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
| | - Brian K Kwon
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
| | - Scott J Paquette
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
| | - Nicolas Dea
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
| | - Raphaële Charest-Morin
- 3Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada
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Inculet C, Urquhart JC, Rasoulinejad P, Hall H, Fisher C, Attabib N, Thomas K, Ahn H, Johnson M, Glennie A, Nataraj A, Christie SD, Stratton A, Yee A, Manson N, Paquet J, Rampersaud YR, Bailey CS. Factors associated with using an interbody fusion device for low-grade lumbar degenerative versus isthmic spondylolisthesis: a retrospective cohort study. J Neurosurg Spine 2021; 35:299-307. [PMID: 34214985 DOI: 10.3171/2020.11.spine201261] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2020] [Accepted: 11/19/2020] [Indexed: 11/06/2022]
Abstract
OBJECTIVE Many studies have utilized a combined cohort of patients with degenerative spondylolisthesis (DS) and isthmic spondylolisthesis (IS) to evaluate indications and outcomes. Intuitively, these are very different populations, and rates, indications, and outcomes may differ. The goal of this study was to compare specific patient characteristics associated with the utilization of a posterior lumbar interbody device between cohorts of patients with DS and IS, as well as to compare rates of interbody device use and patient-rated outcomes at 1 year after surgical treatment. METHODS The authors included patients who underwent posterior lumbar interbody fusion or instrumented posterolateral fusion for grade I or II DS or IS and had been enrolled in the Canadian Spine Outcomes and Research Network registry from 2009 to 2016. The outcome measures were score on the Oswestry Disability Index, scores for back pain and leg pain on the numeric rating scale, and mental component summary (MCS) score and physical component summary score on the 12-Item Short-Form Health Survey. Descriptive statistics were used to compare spondylolisthesis groups, logistic regression was used to compare interbody device use, and the chi-square test was used to compare the proportions of patients who achieved a minimal clinically important difference (MCID) at 1 year after surgery. RESULTS In total, 119 patients had IS and 339 had DS. Patients with DS were more commonly women, older, less likely to smoke, and more likely to have neurogenic claudication and comorbidities, whereas patients with IS more commonly had radicular pain, neurological deficits, and worse back pain. Spondylolisthesis was more common at the L4-5 level in patients with DS and at the L5-S1 level in patients with IS. Similar proportions of patients had an interbody device (78.6% of patients with DS vs 82.4% of patients with IS, p = 0.429). Among patients with IS, factors associated with interbody device utilization were BMI ≥ 30 kg/m2 and increased baseline leg pain intensity. Factors associated with interbody device utilization in patients with DS were younger age, increased number of total comorbidities, and lower baseline MCS score. For each outcome measure, similar proportions of patients in the surgical treatment and spondylolisthesis groups achieved the MCID at 1 year after surgery. CONCLUSIONS Although the demographic and patient characteristics associated with interbody device utilization differed between cohorts, similar proportions of patients attained clinically meaningful improvement at 1 year after surgery.
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Affiliation(s)
- Clayton Inculet
- 1Division of Orthopaedics, Department of Surgery, Western University/London Health Sciences Centre, London, Ontario
| | | | - Parham Rasoulinejad
- 1Division of Orthopaedics, Department of Surgery, Western University/London Health Sciences Centre, London, Ontario
- 2Lawson Health Research Institute, London, Ontario
| | - Hamilton Hall
- 3Department of Surgery, University of Toronto, Ontario
| | - Charles Fisher
- 4Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia
| | - Najmedden Attabib
- 5Department of Surgery, Canada East Spine Centre, Saint John, New Brunswick
| | | | - Henry Ahn
- 3Department of Surgery, University of Toronto, Ontario
| | - Michael Johnson
- 7Department of Orthopedics and Neurosurgery, University of Manitoba, Winnipeg, Manitoba
| | - Andrew Glennie
- 8Department of Orthopedics and Neurosurgery, Dalhousie University, Halifax, Nova Scotia
| | - Andrew Nataraj
- 11Department of Surgery, University of Alberta, Edmonton, Alberta, Canada
| | - Sean D Christie
- 8Department of Orthopedics and Neurosurgery, Dalhousie University, Halifax, Nova Scotia
| | | | - Albert Yee
- 3Department of Surgery, University of Toronto, Ontario
| | - Neil Manson
- 5Department of Surgery, Canada East Spine Centre, Saint John, New Brunswick
| | - Jérôme Paquet
- 10Department of Surgery, Laval University, Quebec City, Quebec; and
| | | | - Christopher S Bailey
- 1Division of Orthopaedics, Department of Surgery, Western University/London Health Sciences Centre, London, Ontario
- 2Lawson Health Research Institute, London, Ontario
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Rappoport LH, Helsper K, Shirk T. Minimally invasive sacroiliac joint fusion using a novel hydroxyapatite-coated screw: final 2-year clinical and radiographic results. JOURNAL OF SPINE SURGERY 2021; 7:155-161. [PMID: 34296027 DOI: 10.21037/jss-20-627] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/23/2020] [Accepted: 02/22/2021] [Indexed: 11/06/2022]
Abstract
Background The proper diagnosis and treatment of sacroiliac joint (SIJ) pain remains a clinical challenge. Dysfunction of the SIJ can produce pain in the lower back, buttocks, and extremities. The present prospective clinical study is a follow-up report on a previous 1-year report on the use of a novel hydroxyapatite (HA)-coated titanium screw for the surgical treatment of SIJ dysfunction. Methods Data were prospectively collected on 32 consecutive patients who underwent minimally invasive SIJ fusion with a novel HA-coated screw. Clinical assessments and radiographs were collected and evaluated at 24 months postoperatively. Results Mean preoperative visual analog scale (VAS) back, left, and right leg pain scores decreased significantly to 20.0 (±18.4), 5.8 (±8.1), and 11.5 (±20.1) at 24-month follow-up, respectively. Oswestry Disability Index (ODI) scores significantly decreased to 27.5 (±18.8) points at 24 months (P<0.01). Two patients who required revision surgery reported improvement of their symptoms within 3 weeks and did not require subsequent surgery to be performed. Conclusions This study shows positive clinical and functional outcomes for patients who have undergone fusion using HA-coated screws for SIJ dysfunction. SIJ fusion using a HA-coated screw to treat SIJ dysfunction significantly decreased VAS back and leg pain and ODI scores at 2-year follow-up.
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Affiliation(s)
| | | | - Torrey Shirk
- Musculoskeletal Education and Research Center, A Division of Globus Medical, Inc., Audubon, PA, USA
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Clinically Meaningful Improvement Following Cervical Spine Surgery: 30% Reduction Versus Absolute Point-change MCID Values. Spine (Phila Pa 1976) 2021; 46:717-725. [PMID: 33337676 DOI: 10.1097/brs.0000000000003887] [Citation(s) in RCA: 23] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Retrospective analysis of prospectively collected registry data. OBJECTIVE The aim of this study was to compare the performance of 30% reduction to established absolute point-change values for measures of disability and pain in patients undergoing elective cervical spine surgery. SUMMARY OF BACKGROUND DATA Recent studies recommend using a proportional change from baseline instead of an absolute point-change value to define minimum clinically important difference (MCID). METHODS Analyses included 13,179 patients who underwent cervical spine surgery for degenerative disease between April 2013 and February 2018. Participants completed a baseline and 12-month follow-up assessment that included questionnaires to assess disability (Neck Disability Index [NDI]), neck and arm pain (Numeric Rating Scale [NRS-NP/AP], and satisfaction [NASS scale]). Participants were classified as met or not met 30% reduction from baseline in each of the respective measures. The 30% reduction in scores at 12 months was compared to a wide range of established absolute point-change MCID values using receiver-operating characteristic curves, area under the receiver-operating characteristic curve (AUROC), and logistic regression analyses. These analyses were conducted for the entire patient cohort, as well as for subgroups based on baseline severity and surgical approach. RESULTS Thirty percent reduction in NDI and NRS-NP/AP scores predicted satisfaction with more accuracy than absolute point-change values for the total population and ACDF and posterior fusion procedures (P < 0.05). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0-20%: 16.8%) and bed-bound disability (ODI 81%-100%: 16.6%) categories. For pain, there was a 1.9% to 11% and 1.6% to 9.6% AUROC difference for no/mild neck and arm pain (NRS 0-4), respectively, in favor of a 30% reduction threshold. CONCLUSION A 30% reduction from baseline is a valid method for determining MCID in disability and pain for patients undergoing cervical spine surgery.Level of Evidence: 3.
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Zervos TM, Asmaro K, Air EL. Contemporary Analysis of Minimal Clinically Important Difference in the Neurosurgical Literature. Neurosurgery 2021; 88:713-719. [PMID: 33369670 DOI: 10.1093/neuros/nyaa490] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2020] [Accepted: 09/09/2020] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Minimal clinically important difference (MCID) is determined when a patient or physician defines the minimal change that outweighs the costs and untoward effects of a treatment. These measurements are "anchored" to validated quality-of-life instruments or physician-rated, disease-activity indices. To capture the subjective clinical experience in a measurable way, there is an increasing use of MCID. OBJECTIVE To review the overall concept, method of calculation, strengths, and weaknesses of MCID and its application in the neurosurgical literature. METHODS Recent articles were reviewed based on PubMed query. To illustrate the strengths and limitations of MCID, studies regarding the measurement of pain are emphasized and their impact on subsequent publications queried. RESULTS MCID varies by population baseline characteristics and calculation method. In the context of pain, MCID varied based on the quality of pain, chronicity, and treatment options. CONCLUSION MCID evaluates outcomes relative to whether they provide a meaningful change to patients, incorporating the risks and benefits of a treatment. Using MCID in the process of evaluating outcomes helps to avoid the error of interpreting a small but statistically significant outcome difference as being clinically important.
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Marques MF, Fiere V, Obeid I, Charles YP, El-Youssef K, Lahoud A, Faddoul J, Ferrero E, Riouallon G, Silvestre C, Le Huec JC, Kieser D, Boissiere L. Pseudarthrosis in adult spine deformity surgery: risk factors and treatment options. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2021; 30:3225-3232. [PMID: 33950287 DOI: 10.1007/s00586-021-06861-w] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/04/2020] [Accepted: 04/27/2021] [Indexed: 10/21/2022]
Abstract
PURPOSE Highlight risk factors for pseudarthrosis in long-segment spinal fusions, collect the approaches carried to address this complication. METHODS Patients with ASD and fusion of ≥ 4 levels with minimum follow-up (FU) of ≥ 2 years were included. Full-body X-rays were done preoperatively, < 3 months and ≥ 2 years. Oswestry disability index (ODI), Scoliosis Research Society-22 and SF36 assessed pre- and postoperatively. The relationship between demographic, surgical and radiological variables with the development of pseudarthrosis was evaluated. RESULTS Out of 524 patients included, 65 patients (12.4%) developed pseudarthrosis and 53 underwent revision surgery. Notably, 88% of pseudarthrosis cases are associated with fusion length (OR = 1.17, 95% CI = 1.05-1.292, p = 0.004), osteotomy requirement (OR = 0.28, 95% CI = 0.09-0.85, p = 0.025), pelvic fixation (OR = 0.34, 95% CI = 0.13-0.88, p = 0.026) and combined approaches (OR = 3.29, 95% CI = 1.09-9.91, p = 0.034). Sagittal alignment is not related to the rate of pseudarthrosis. Health related and quality of life scores were comparable at last FU between patients revised for pseudarthrosis and those that didn't require revision surgery (ODI = 28% no revision and 30% revision group). CONCLUSIONS Pseudarthrosis is not related to malalignment, but with the surgical techniques employed for its treatment. Anterior approaches with anterior support decrease the rate by 30%, while long fusions, osteotomies and pelvic fixation increase its rate.
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Affiliation(s)
| | - Vincent Fiere
- Spinal Unit, Santy Orhopaedic Center and Mermoz Hospital Ramsay GDS, Lyon, France
| | - Ibrahim Obeid
- Bordeaux University Hospital, Department of Spinal Surgery Unit 1, C.H.U Tripode Pellegrin, Université de Bordeaux, Place Amélie Raba Léon, 33076, Bordeaux, France.,Clinique du Dos-Bordeaux and ELSAN Polyclinique Jean Villar, 33520, Bruges, France
| | - Yann-Philippe Charles
- Department of Spine Surgery, Strasbourg University Hospital, 1, place de l'Hôpital, BP 426, 67091, Strasbourg Cedex, France
| | - Khaled El-Youssef
- Chirurgie Orthopedique et Traumatologique - Clocheville, Centre Hospitalier Regional Universitaire de Tours, Tours, France
| | - Abi Lahoud
- Neurosurgery Department, Sainte-Anne Hospital, Paris, France
| | - Joe Faddoul
- Neurosurgery Department, Sainte-Anne Hospital, Paris, France
| | - Emmanuelle Ferrero
- Department of Orthopaedic Surgery, Hôpital Georges Pompidou, 75015, Paris, France
| | - Guillaume Riouallon
- Service de Chirurgie Orthopédique, Groupe Hospitalier Paris Saint-Joseph, 75014, Paris, France
| | | | - Jean-Charles Le Huec
- Orthopédie-Traumatologie Department, Polyclinique Bordeaux Nord Aquitaine, 33000, Bordeaux, France
| | - David Kieser
- Department of Orthopaedic Surgery and Musculoskeletal Medicine, University of Otago, 2 Riccarton Avenue, Christchurch, 8011, New Zealand.
| | - Louis Boissiere
- Bordeaux University Hospital, Department of Spinal Surgery Unit 1, C.H.U Tripode Pellegrin, Université de Bordeaux, Place Amélie Raba Léon, 33076, Bordeaux, France.,Clinique du Dos-Bordeaux and ELSAN Polyclinique Jean Villar, 33520, Bruges, France
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Lynch CP, Cha EDK, Jenkins NW, Parrish JM, Mohan S, Jadczak CN, Geoghegan CE, Singh K. The Minimum Clinically Important Difference for Patient Health Questionnaire-9 in Minimally Invasive Transforaminal Interbody Fusion. Spine (Phila Pa 1976) 2021; 46:603-609. [PMID: 33290370 DOI: 10.1097/brs.0000000000003853] [Citation(s) in RCA: 43] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Retrospective cohort. OBJECTIVE To investigate and establish minimum clinically important differences (MCID) for Patient Health Questionnaire-9 (PHQ-9) among patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). SUMMARY OF BACKGROUND Spine surgery is linked to postoperative improvements in anxiety, depression, and mental health. These improvements have been documented using patient-reported outcome measures such as PHQ-9. Few studies evaluated the clinical significance of PHQ-9 for lumbar spine surgery. METHODS Patients who underwent single-level, primary MIS TLIF from 2015 to 2017 were retrospectively reviewed in a prospective database. Patients with incomplete preoperative and 2-year postoperative PHQ-9 surveys were excluded. Demographic and perioperative characteristics were recorded. PHQ-9, 12-Item Short Form (SF-12), and Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) were collected at preoperative, 6-week, 12-week, 6-month, 1-year, and 2-year intervals. MCID was calculated using anchor and distribution-based methods. SF-12 served as an anchor. MCID was assessed using mean change methodology, four receiver operating characteristic curve assessments, and standard error measurement. Cutoff values were selected from receiver operating characteristic curve analysis. MCID achievement rates for all patient-reported outcome measures were calculated. RESULTS A total of 139 patients met inclusion criteria, with a mean age of 55 years and 39% females. The most common spinal pathology was radiculopathy (92%). MCID analysis revealed the following ranges of values: 2.0 to 4.8 (PHQ-9), 6.7 to 12.1 (SF-12 MCS), and 7.5 to 15.9 (VR-12 MCS). Final MCID thresholds were 3.0 (PHQ-9), 9.1 (SF-12 MCS), and 8.1 (VR-12 MCS). MCID achievement at 2-years for PHQ-9, SF-12 MCS, and VR-12 MCS was 89.2%, 85.6%, and 84.9% respectively. CONCLUSION Our 2-year postoperative MCID analysis is the first mental health calculation from an MIS TLIF cohort. We report a 2-year MCID value for PHQ-9 of 3.0 (2.0-4.8). MCID values for mental health instruments are important for determining overall success of lumbar spine surgery.Level of Evidence: 3.
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Affiliation(s)
- Conor P Lynch
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL
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Ayling OGS, Ailon T, Street JT, Dea N, McIntosh G, Abraham E, Jacobs WB, Soroceanu A, Johnson MG, Paquet J, Rasoulinejad P, Phan P, Yee A, Christie S, Nataraj A, Glennie RA, Hall H, Manson N, Rampersaud YR, Thomas K, Fisher CG. The Effect of Perioperative Adverse Events on Long-Term Patient-Reported Outcomes After Lumbar Spine Surgery. Neurosurgery 2021; 88:420-427. [PMID: 33009559 DOI: 10.1093/neuros/nyaa427] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2019] [Accepted: 06/28/2020] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Perioperative adverse events (AEs) lead to patient disappointment and greater costs. There is a paucity of data on how AEs affect long-term outcomes. OBJECTIVE To examine perioperative AEs and their impact on outcome after lumbar spine surgery. METHODS A total of 3556 consecutive patients undergoing surgery for lumbar degenerative disorders enrolled in the Canadian Spine Outcomes and Research Network were analyzed. AEs were defined using the validated Spine AdVerse Events Severity system. Outcomes at 3, 12, and 24 mo postoperatively included the Owestry Disability Index (ODI), 12-Item Short-Form Health Survey (SF-12) Physical (PCS) and Mental (MCS) Component Summary scales, visual analog scale (VAS) leg and back, EuroQol-5D (EQ5D), and satisfaction. RESULTS AEs occurred in 767 (21.6%) patients, and 85 (2.4%) patients suffered major AEs. Patients with major AEs had worse ODI scores and did not reach minimum clinically important differences at 2 yr (no AE: 25.7 ± 19.2, major: 36.4 ± 19.1, P < .001). Major AEs were associated with worse ODI scores on multivariable linear regression (P = .011). PCS scores were lower after major AEs (43.8 ± 9.5, vs 37.7 ± 20.3, P = .002). On VAS leg and back and EQ5D, the 2-yr outcomes were significantly different between the major and no AE groups (<0.01), but these differences were small (VAS leg: 3.4 ± 3.0 vs 4.0 ± 3.3; VAS back: 3.5 ± 2.7 vs 4.5 ± 2.6; EQ5D: 0.75 ± 0.2 vs 0.64 ± 0.2). SF12 MCS scores were not different. Rates of satisfaction were lower after major AEs (no AE: 84.6%, major: 72.3%, P < .05). CONCLUSION Major AEs after lumbar spine surgery lead to worse functional outcomes and lower satisfaction. This highlights the need to implement strategies aimed at reducing AEs.
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Affiliation(s)
- Oliver G S Ayling
- Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, Canada
| | - Tamir Ailon
- Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, Canada
| | - John T Street
- Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, Canada
| | - Nicolas Dea
- Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, Canada
| | | | - Edward Abraham
- Department of Surgery, Canada East Spine Centre, Saint John, Canada
| | - W Bradly Jacobs
- Department of Surgery, University of Calgary, Calgary, Canada
| | - Alex Soroceanu
- Department of Surgery, University of Calgary, Calgary, Canada
| | - Michael G Johnson
- Departments of Orthopedics and Neurosurgery, University of Manitoba, Winnipeg, Canada
| | - Jerome Paquet
- Department of Surgery, Laval University, Quebec City, Canada
| | | | - Phillipe Phan
- Department of Surgery, University of Ottawa, Ottawa, Canada
| | - Albert Yee
- Department of Surgery, University of Toronto, Toronto, Canada
| | - Sean Christie
- Department of Surgery, Dalhousie University, Halifax, Canada
| | - Andrew Nataraj
- Department of Surgery, University of Alberta, Edmonton, Canada
| | | | - Hamilton Hall
- Department of Surgery, University of Toronto, Toronto, Canada
| | - Neil Manson
- Department of Surgery, Canada East Spine Centre, Saint John, Canada
| | | | - Kenneth Thomas
- Department of Surgery, University of Calgary, Calgary, Canada
| | - Charles G Fisher
- Department of Surgery, Vancouver General Hospital/University of British Columbia, Vancouver, Canada
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Leonova ON, Cherepanov EA, Krutko AV. MIS-TLIF versus O-TLIF for single-level degenerative stenosis: study protocol for randomised controlled trial. BMJ Open 2021; 11:e041134. [PMID: 33674366 PMCID: PMC7938991 DOI: 10.1136/bmjopen-2020-041134] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/16/2023] Open
Abstract
INTRODUCTION Patients with symptomatic single-level combination of degenerative stenosis and low-grade spondylolisthesis are often treated by nerve root decompression and spinal fusion. The gold standard is traditional open decompression and fusion, but minimally invasive method is more and more prevailing. However, there is lack of high-quality studies comparing these two techniques in order to obtain the advantages and certain indications to use one of these methods. The current study includes clinical, safety and radiological endpoints to determine the effectiveness of minimally invasive decompression and fusion (MIS-TLIF) over the traditional open one (O-TLIF). METHODS AND ANALYSIS All patients aged 40-75 years with neurogenic claudication or bilateral radiculopathy caused by single-level combination of degenerative stenosis and low-grade spondylolisthesis, confirmed by MRI with these symptoms persisting for at least 3 months prior to surgery, are eligible. Patients will be randomised into MIS-TLIF or traditional O-TLIF. The primary outcome measure is Oswestry Disability Index at 3-month follow-up term. The secondary outcomes are patient-reported outcome measures by the number of clinical scales, radiological parameters including sagittal balance parameters, safety endpoints and cost-effectiveness of each method. All patients will be analysed preoperatively, as well as on the 14th day of hospital stay (or on the day of hospital discharge), 3 months, 6 months, 12 months and 24 months postoperatively. The study has the design of a parallel group to demonstrate the non-inferior clinical results of MIS-TLIF compared with the traditional O-TLIF. ETHICS AND DISSEMINATION The study will be performed according to Helsinki Declaration. The study protocol was approved by the Local Ethical Committee of Priorov National Medical Research Center of Traumatology and Orthopedics in August 2020. Preliminary and final results will be presented in peer-reviewed journals, especially orthopaedic and spine surgery journals, at national and international congresses. TRIAL REGISTRATION NUMBER NCT04594980.
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Affiliation(s)
- Olga N Leonova
- Neurosurgery Department, Novosibirsk Research Institute of Traumatology and Orthopaedics, Novosibirsk, Russian Federation
| | | | - Aleksandr V Krutko
- Neurosurgery Department, Priorov National Medical Research Center of Traumatology and Orthopedics, Mosсow, Russian Federation
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Budiono GR, McCaffrey MH, Parr WCH, Choy WJ, Singh T, Pelletier MH, Mobbs RJ. Development of a Multivariate Prediction Model for Successful Oswestry Disability Index Changes in L5/S1 Anterior Lumbar Interbody Fusion for Degenerative Disc Disease. World Neurosurg 2020; 148:e1-e9. [PMID: 33189919 DOI: 10.1016/j.wneu.2020.11.024] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2020] [Revised: 11/04/2020] [Accepted: 11/05/2020] [Indexed: 11/15/2022]
Abstract
OBJECTIVE Lower back pain associated with degenerative disc disease (DDD) is a leading cause of disability worldwide. Anterior lumbar interbody fusion (ALIF) has been shown to be effective for treating refractory DDD, but it remains unclear which patients may benefit most from the procedure. This study aims to develop a predictive model for clinical success in L5/S1 ALIF for DDD. METHODS A retrospective cohort study of 68 patients with refractory DDD who underwent L5/S1 ALIF was performed. Clinical success was defined as an improvement in Oswestry Disability Index (ODI) of 20 points postoperatively. Exploratory analyses were performed on 16 preoperative clinical and radiographic parameters, followed by a multivariate logistic regression. Evaluation of the predictive model was performed. RESULTS After exploratory analyses, 4 parameters were suitable for inclusion in the multivariate model. Workers' compensation status (odds ratio [OR], 0.02; 95% confidence interval [CI], 0.001-0.262; P = 0.004) and preoperative ODI (OR, 1.13; 95% CI, 1.05-1.23; P = 0.002) were statistically significant parameters. Furthermore, posterior disc height and disc depth contributed significantly to the model variance (OR, 0.69, 95% CI, 0.44-1.09 and OR, 0.97, 95% CI, 0.81-1.15, respectively). The model had a sensitivity of 81.5%, specificity of 83.3%, C-statistic of 0.921, and a calibration plot similar to the 45° reference line. CONCLUSIONS This analysis confirms workers' compensation and low preoperative ODI as risk factors for successful L5/S1 ALIF performed for DDD. It also identifies novel prognostic factors, namely posterior disc height and disc depth. This model can aid in patient counseling and selection in the management of L5/S1 DDD.
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Affiliation(s)
- Gideon R Budiono
- NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia; NeuroSpine Clinic, Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales (UNSW), Sydney, New South Wales, Australia.
| | - Miles H McCaffrey
- NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia; NeuroSpine Clinic, Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, New South Wales, Australia
| | - William C H Parr
- NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales (UNSW), Sydney, New South Wales, Australia; Surgical and Orthopaedic Research Laboratories, Prince of Wales Clinical School, Sydney, New South Wales, Australia; 3DMorphic Pty Ltd., Sydney, New South Wales, Australia
| | - Wen J Choy
- NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia; NeuroSpine Clinic, Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales (UNSW), Sydney, New South Wales, Australia
| | - Telvinderjit Singh
- NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia; NeuroSpine Clinic, Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales (UNSW), Sydney, New South Wales, Australia; Surgical and Orthopaedic Research Laboratories, Prince of Wales Clinical School, Sydney, New South Wales, Australia
| | - Matthew H Pelletier
- NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales (UNSW), Sydney, New South Wales, Australia; Surgical and Orthopaedic Research Laboratories, Prince of Wales Clinical School, Sydney, New South Wales, Australia
| | - Ralph J Mobbs
- NeuroSpine Surgery Research Group (NSURG), Prince of Wales Private Hospital, Sydney, New South Wales, Australia; NeuroSpine Clinic, Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales (UNSW), Sydney, New South Wales, Australia; Surgical and Orthopaedic Research Laboratories, Prince of Wales Clinical School, Sydney, New South Wales, Australia
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Massel DH, Mayo BC, Narain AS, Hijji FY, Louie PK, Jenkins NW, Parrish JM, Singh K. Improvements in Back and Leg Pain Following a Minimally Invasive Transforaminal Lumbar Interbody Fusion. Int J Spine Surg 2020; 14:745-755. [PMID: 33184122 DOI: 10.14444/7107] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/26/2023] Open
Abstract
BACKGROUND Improvement in patient-reported outcomes after minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) is poorly defined. As such, the purpose of this study was to quantify improvements in Visual Analogue Scale back and leg pain, Oswestry Disability Index (ODI), and Short Form-12 (SF-12) Mental and Physical Composite scores following MIS-TLIF. METHODS A surgical registry of patients who underwent primary 1-level MIS-TLIF during 2014-2015 was reviewed. Comparisons of Visual Analogue Scale back and leg pain, ODI, and Short Form-12 Mental and Physical Composite scores were performed using paired t tests from preoperative to each postoperative time point. Analysis of variance was used to estimate the degree of improvement in back and leg pain over the first postoperative year. Subgroup analysis was performed for patients presenting with predominant back (pBP) or leg (pLP) pain. Multivariate linear regression was performed to compare patient-reported outcome scores by subgroup. RESULTS A total of 106 patients were identified. Visual Analogue Scale back and leg scores, and ODI improved from preoperative scores at all postoperative time points (P < .05 for each). Patients with pBP (n = 68) and patients with pLP (n = 38) reported reductions in both back and leg pain over the first postoperative year (P < .05 for each). In the pBP cohort, patients experienced significant reductions in ODI after the first 6 postoperative weeks (P < .05 for each). In the pLP cohort, patients experienced significant reductions in ODI throughout the first postoperative year (P < .05 for each). Patients with pLP and pBP experienced similar reductions in back pain, whereas patients with pLP experienced significantly greater reductions in leg pain at all postoperative time points (P < .05 for each). CONCLUSIONS The current study suggests patients experience significant improvements in back and leg pain following MIS-TLIF regardless of predominant symptom. CLINICAL RELEVANCE These results can assist surgeons when counseling their patients on the magnitude of symptom improvement they may experience following MIS-TLIF.
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Affiliation(s)
- Dustin H Massel
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Benjamin C Mayo
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Ankur S Narain
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Fady Y Hijji
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Philip K Louie
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Nathaniel W Jenkins
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - James M Parrish
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Kern Singh
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
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Alvarez-Galovich L, Tome-Bermejo F, Moya AB, Mahillo-Fernandez I, PiÑera AR, Mengis CL, Gallego JM, GarzÓn FM, Rodriguez MG, Sanz S, Peiro-Garcia A. Safety and Efficacy With Augmented Second-Generation Perforated Pedicle Screws in Treating Degenerative Spine Disease in Elderly Population. Int J Spine Surg 2020; 14:811-817. [PMID: 33097578 DOI: 10.14444/7115] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/16/2023] Open
Abstract
BACKGROUND Degenerative spine disease is a common cause of low back pain in people age 65 years or older. Nonsurgical treatment is tried first, but if it is unsuccessful, surgery is advocated. This has special connotations for both underlying disease and the biomechanical characteristics of osteoporotic bone. We conducted an observational study to investigate the clinical and radiological outcome in patients in this age group with poor bone quality and degenerative lumbar instability treated with fusion using perforated pedicle screws augmented with polymethylmethacrylate (PMMA). METHODS We collected prospective data on treatment, outcome, and patient characteristics from our institution's database. The primary outcome was a change in pain and physical function measured by the visual analog scale, the Core Outcome Measures Index, and the Oswestry Disability Index. Control participants were also analyzed for secondary complications such as hardware mobilization, fusion (as apparent on radiographs), and adjacent fractures or adjacent degenerative disc disease. RESULTS We included 89 patients who underwent surgery between October 2015 and February 2018 at a mean age of 78 years (range, 67-88 years) and were then monitored for at least 12 months (range, 12-40 months). Findings on pain and function questionnaires showed improvement at 6 months after surgery, maintained at the final evaluation; 90% of patients had final score increases of ≥15 points. No patient developed clinical complications secondary to PMMA leakages. One patient had nonunion and screw breakage. No other patient had clinical or radiological nonunion. Of the control participants, 6 had adjacent disc disease, with 2 of them requiring instrumentation extension. Six deep infections required surgical revision without removal of material. CONCLUSION PMMA-augmented cannulated pedicle screw instrumentation in spine fusion effectively and safely treats degenerative lumbar disease in patients who are age 65 years or older with poor bone quality.
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Affiliation(s)
| | | | - Ana B Moya
- Spine Service, Fundación Jimenez Diaz, Madrid, Spain
| | | | | | | | | | | | | | - Sylvia Sanz
- Spine Service, Fundación Jimenez Diaz, Madrid, Spain
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The Effect of Preoperative Symptom Duration on Postoperative Outcomes After Minimally Invasive Transforaminal Lumbar Interbody Fusion. Clin Spine Surg 2020; 33:E263-E268. [PMID: 31503049 DOI: 10.1097/bsd.0000000000000881] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
STUDY DESIGN Retrospective. OBJECT This study aims to examine whether the time spanning from symptom onset to surgical intervention has an effect on postoperative clinical improvement in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). SUMMARY OF BACKGROUND DATA Evidence is limited regarding the influence of preoperative symptom duration on patient-reported outcomes (PROs). METHODS Patients undergoing a primary, single-level minimally invasive transforaminal lumbar interbody fusion were retrospectively reviewed and stratified according to preoperative symptom duration (<12 mo and ≥12 mo). Differences in PROs, including Oswestry Disability Index (ODI), 12-Item Short-Form Physical Component Score (SF-12 PCS), Visual Analogue Scale (VAS) back pain, and VAS leg pain, at each postoperative timepoint and were compared between duration of symptoms (DOS) cohorts using linear regression. Achievement of minimal clinically important difference (MCID) for PROs was compared using χ analysis. RESULTS A total of 248 patients were included: 96 had a DOS <12 months and 152 had a DOS >12 months. When comparing PROs preoperatively, the shorter DOS cohort had significantly worse ODI, VAS leg pain, and SF-12 PCS compared with patients with longer DOS. However, there was no preoperative difference in VAS back pain between cohorts. Postoperatively, there were no significant differences in improvement of PROs throughout the 12-month timepoint. The shorter DOS cohort had a comparable number of patients achieving MCID for ODI, VAS back pain, VAS leg pain, and SF-12 PCS relative to the longer DOS cohort. CONCLUSIONS In our study, patients with DOS <12 months exhibited significantly worse ODI and VAS leg pain scores at the time of surgery compared with patients with longer DOS. However, these patients demonstrated similar clinical improvement postoperatively regardless of preoperative symptom duration. These findings suggest that delayed surgical intervention may not lead to impaired functional recovery in patients with degenerative lumbar disease.
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Measuring clinically relevant improvement after lumbar spine surgery: is it time for something new? Spine J 2020; 20:847-856. [PMID: 32001385 DOI: 10.1016/j.spinee.2020.01.010] [Citation(s) in RCA: 40] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2019] [Revised: 01/22/2020] [Accepted: 01/23/2020] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Minimum clinically important difference (MCID) for patient-reported outcome measures is commonly used to assess clinical improvement. However, recent literature suggests that an absolute point-change may not be an effective or reliable marker of response to treatment for patients with low or high baseline patient-reported outcome scores. The multitude of established MCIDs also makes it difficult to compare outcomes across studies and different spine surgery procedures. PURPOSE To determine whether a 30% reduction from baseline in disability and pain is a valid method for determining clinical improvement after lumbar spine surgery. STUDY DESIGN Retrospective analysis of prospective data from a national spine registry, the Quality Outcomes Database. PATIENT SAMPLE There were 23,280 participants undergoing elective lumbar spine surgery for degenerative disease who completed a baseline and follow-up assessment at 12 months. OUTCOME MEASURES Patient-reported disability (Oswestry Disability Index [ODI]), back and leg pain (11-point Numeric Rating Scale [NRS]), and satisfaction (NASS scale). METHODS Patients completed baseline and a 12-month postoperative assessment to evaluate the outcomes of disability, pain, and satisfaction. The change in ODI and NRS pain scores was categorized as met (≥30%) or not met (<30%) percent reduction MCID. The 30% reduction from baseline was compared with a wide range of well-established absolute point-change MCID values. The relationship between 30% reduction and absolute change values and satisfaction were primarily compared using receiver operating characteristic (ROC) curves, area under the curve (AUROC), and logistic regression analyses. Analyses were conducted for overall scores and for disability and pain severity categories and by surgical procedure. RESULTS Thirty percent reduction in ODI and back and leg pain predicted satisfaction with more accuracy than absolute point-change values for the total population and across all procedure categories (p<.001), except for when compared with the highest absolute point-change threshold for leg pain (3.5-point reduction). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0-20%: 21.8%) and bed-bound disability (ODI 81%-100%: 13.9%) categories. For pain, there was a 3.4%-12.4% and 1.3%-9.8% AUROC difference for no/mild back and leg pain (NRS 0-4), respectively, in favor of a 30% reduction threshold. CONCLUSIONS A 30% reduction MCID either outperformed or was similar to absolute point-change MCID values. Results indicate that a 30% reduction (baseline to 12 months after surgery) in disability and pain is a valid method for determining clinically relevant improvement in a broad spine surgery population. Furthermore, a 30% reduction was most accurate for patients in the lowest and highest disability and lowest pain severity categories. A 30% reduction MCID allows for a standard cut-off for disability and pain that can be used to compare outcomes across various spine surgery procedures.
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Mouelhi Y, Jouve E, Castelli C, Gentile S. How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods. Health Qual Life Outcomes 2020; 18:136. [PMID: 32398083 PMCID: PMC7218583 DOI: 10.1186/s12955-020-01344-w] [Citation(s) in RCA: 266] [Impact Index Per Article: 53.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2019] [Accepted: 04/01/2020] [Indexed: 12/19/2022] Open
Abstract
Background The aim of this systematic review is to describe the different types of anchors and statistical methods used in estimating the Minimal Clinically Important Difference (MCID) for Health-Related Quality of Life (HRQoL) instruments. Methods PubMed and Google scholar were searched for English and French language studies published from 2010 to 2018 using selected keywords. We included original articles (reviews, meta-analysis, commentaries and research letters were not considered) that described anchors and statistical methods used to estimate the MCID in HRQoL instruments. Results Forty-seven papers satisfied the inclusion criteria. The MCID was estimated for 6 generic and 18 disease-specific instruments. Most studies in our review used anchor-based methods (n = 41), either alone or in combination with distribution-based methods. The most common applied anchors were non-clinical, from the viewpoint of patients. Different statistical methods for anchor-based methods were applied and the Change Difference (CD) was the most used one. Most distributional methods included 0.2 standard deviations (SD), 0.3 SD, 0.5 SD and 1 standard error of measurement (SEM). MCID values were very variable depending on methods applied, and also on clinical context of the study. Conclusion Multiple anchors and methods were applied in the included studies, which lead to different estimations of MCID. Using several methods enables to assess the robustness of the results. This corresponds to a sensitivity analysis of the methods. Close collaboration between statisticians and clinicians is recommended to integrate an agreement regarding the appropriate method to determine MCID for a specific context.
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Affiliation(s)
- Yosra Mouelhi
- Laboratoire de Santé Publique, Faculté de Médecine, Université Aix-Marseille, 3279, Marseille, EA, France
| | - Elisabeth Jouve
- Service d'Evaluation Médicale, Assistance Publique - Hôpitaux de Marseille, Marseille, France
| | - Christel Castelli
- Service Biostatistique Epidemiologie Santé Publique Innovation et Méthodologie (BESPIM), CHU Nîmes, Nîmes, France.,UPRES EA 2415 Aide à la décision médicale personnalisée, Faculté de Médecine, Université de Montpellier, Montpellier, France
| | - Stéphanie Gentile
- Laboratoire de Santé Publique, Faculté de Médecine, Université Aix-Marseille, 3279, Marseille, EA, France. .,Service d'Evaluation Médicale, Assistance Publique - Hôpitaux de Marseille, Marseille, France.
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Mayo BC, Narain AS, Hijji FY, Massel DH, Bohl DD, Singh K. Preoperative Mental Health May Not Be Predictive of Improvements in Patient-Reported Outcomes Following a Minimally Invasive Transforaminal Lumbar Interbody Fusion. Int J Spine Surg 2020; 14:26-31. [PMID: 32128299 DOI: 10.14444/7003] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
Background Prior literature has associated poor preoperative mental health with inferior patient-reported outcomes (PROs) after spinal procedures. Therefore, the objective of this study was to test for association of preoperative Short Form 12 (SF-12) mental health composite score (MCS) with improvements in Oswestry Disability Index (ODI) and back and leg visual analogue scale (VAS) pain scores after a minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Methods A surgical database of patients who underwent a primary, 1 level MIS TLIF was reviewed. Preoperative SF-12 MCS was tested for association with preoperative ODI, back VAS, and leg VAS. Preoperative MCS was then tested for association with changes in ODI, back VAS, and leg VAS from preoperative to postoperative visits. These tests were conducted using multivariate regression controlling for baseline characteristics and the preoperative score of the PRO being assessed. Results A total of 113 patients were included in the analysis. At baseline, higher preoperative MCS was associated with lower preoperative ODI (coefficient: -0.58, P < .001), lower preoperative back VAS (-0.05, P = .003), and lower preoperative leg VAS (-0.06, P = .003). However, there was no association between preoperative MCS and improvement in PROs at any postoperative timepoint (P > .05). The percent of patients achieving a minimum clinically important difference in PROs at 6 months did not differ between the bottom and top MCS halves (P > .05). Conclusions The results of this study suggest that better preoperative mental health is associated with lower perceived preoperative disability and decreased severity of back and leg pain. In contrast to other studies, the present study was unable to demonstrate that preoperative mental health is predictive of improvement in PROs at any postoperative timepoint after MIS TLIF. Level of Evidence 3. Clinical Relevance These results suggest that surgeons should exercise care in assuming that patients with poorer preoperative mental health are inferior surgical candidates.
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Affiliation(s)
- Benjamin C Mayo
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Ankur S Narain
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Fady Y Hijji
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Dustin H Massel
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Daniel D Bohl
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
| | - Kern Singh
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
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Li L, Chang F, Hai Y, Yang J, Xu C, Yuan J, Sun J, Wang Q, Ding S, Yang X. Clinical effect evaluation and correlation between preoperative imaging parameters and clinical effect of endoscopic Transforaminal decompression for lumbar spinal stenosis. BMC Musculoskelet Disord 2020; 21:68. [PMID: 32013945 PMCID: PMC6998066 DOI: 10.1186/s12891-020-3076-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2017] [Accepted: 01/20/2020] [Indexed: 11/24/2022] Open
Abstract
BACKGROUND The objective of this study was to evaluate the clinical effect and correlation between preoperative imaging parameters and the clinical effect of endoscopic transforaminal decompression for lumbar spinal stenosis. METHODS In this prospective study, 87 patients from Shanxi Province People's Hospital met the criteria for lumbar spinal stenosis and were recruited from June 2014 to January 2016. These patients underwent endoscopic transforaminal decompression. The clinical symptoms were evaluated by VAS, ODI, and claudication at 3 and 6 months after surgery. The overall clinical efficacy was evaluated using the MacNab score. Yellow ligament thickness and area of the dural sac were examined by MRI. Bony vertebral canal area, real spinal canal area, nerve root canal bony area, nerve root canal real area, distance between the articular joints, and vertebral canal sagittal diameter were examined by CT. The soft tissue invasion ratio of the vertebral canal and the invasion ratio of the nerve root canal were calculated. Correlations between imaging parameters and age, sex, and clinical efficacy were examined. RESULTS The MacNab scores were excellent in 47% of cases, good in 34%, generally good in 8%, and poor in 11%. VAS, ODI, and claudication were significantly improved compared with the preoperative values (P < 0.01). A significant difference was observed between the 71-81 year age group and the other age groups (P < 0.05). There were good correlations between clinical efficacy and vertebral canal sagittal diameter, distance between the articular joints, soft tissue invasion ratio of the vertebral canal, and invasion ratio of the nerve root canal. CONCLUSION Treatment of lumbar spinal stenosis by endoscopic transforaminal decompression can achieve good clinical results. This operation is less effective in patients older than 71 years of age. There were positive correlations between clinical efficacy and the vertebral canal sagittal diameter, the articular joints, soft tissue invasion ratio of the vertebral canal, and invasion ratio of the nerve root canal.
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Affiliation(s)
- Lijun Li
- Department of Orthopedics, Capital Medical University Affiliated Beijing Chaoyang Hospital, Beijing, China
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
| | - Feng Chang
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
| | - Yong Hai
- Department of Orthopedics, Capital Medical University Affiliated Beijing Chaoyang Hospital, Beijing, China.
| | - Jincai Yang
- Department of Orthopedics, Capital Medical University Affiliated Beijing Chaoyang Hospital, Beijing, China
| | - Cheng Xu
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
| | - Jie Yuan
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
| | - Jiuqiang Sun
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
| | - Qinghua Wang
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
| | - Shengqiang Ding
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
| | - Xiaowen Yang
- Department of Orthopedics, Shanxi Provincial People's Hospital, Shanxi, China
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Improvements in Back and Leg Pain After Minimally Invasive Lumbar Decompression. HSS J 2020; 16:62-71. [PMID: 32015742 PMCID: PMC6973967 DOI: 10.1007/s11420-018-09661-z] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/16/2018] [Accepted: 12/06/2018] [Indexed: 02/07/2023]
Abstract
BACKGROUND Few studies have quantified clinical improvement following minimally invasive lumbar decompression based on predominant back pain or leg pain. PURPOSE To quantify improvement in patient-reported outcomes following minimally invasive lumbar decompression and determine the degree of improvement in back pain, leg pain, and disability in patients who present with predominant back pain or predominant leg pain. METHODS Patients who underwent primary, one-level minimally invasive lumbar decompression for degenerative pathology were retrospectively reviewed. Comparisons of visual analog scale (VAS) back and leg pain scores, Oswestry Disability Index (ODI) scores, and Short Form-12 (SF-12) mental and physical component scores from pre-operative to 6-week, 12-week, 6-month, and 1-year follow-up. Subgroup analyses were performed for patients with predominant back pain or predominant leg pain. RESULTS A total of 102 patients were identified. Scores on VAS back and leg pain, ODI, and SF-12 physical component improved from pre-operative to all post-operative time points. After 1 year, patients reported a 2.8-point (47%) reduction in back pain and a 4-point (61.1%) reduction in leg pain scores; 52 patients with predominant back pain and 50 patients with predominant leg pain reported reductions in pain throughout the year following surgery. In both the back and leg pain cohorts, patients experienced reductions in ODI during the first 6 months and throughout 1-year follow-up, respectively. The majority of patients achieved minimum clinically important difference, regardless of predominant symptom. CONCLUSIONS Patients reported improvements in back and leg pain following minimally invasive lumbar decompression regardless of predominant presenting symptom; however, patients with predominant leg pain may experience greater improvement than those with predominant back pain.
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Kelly JP, Alcala-Marquez C, Dawson JM, Mehbod AA, Pinto MR. Treatment of degenerative spondylolisthesis by instrumented posterolateral versus instrumented posterolateral with transforaminal lumbar interbody single-level fusion. JOURNAL OF SPINE SURGERY 2019; 5:351-357. [PMID: 31663046 DOI: 10.21037/jss.2019.08.09] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
Background The purpose of this study was to compare outcomes of patients with degenerative spondylolisthesis treated by posterolateral lumbar fusion (PLF) versus PLF with transforaminal lumbar interbody fusion (PLF + TLIF). Studies of PLF versus PLF + TLIF have shown either equivalence or support for PLF + TLIF in lumbar spine surgery. Many are heterogeneous in the conditions treated, with few considering only spondylolisthesis of degenerative origin. Radiographic outcomes tend to favor PLF + TLIF, but this has not translated into better clinical outcomes. Methods This was a retrospective cohort study. Forty-nine patients undergoing single-level PLF and seventy patients undergoing single-level PLF + TLIF with two-year follow-up were retrospectively reviewed. Demographics, Oswestry Disability Index (ODI), implant cost, surgical data, and complications were analyzed. Results There was no difference in ODI improvement at two-year follow-up between the cohorts (P=0.97). Dural tears were more common in the PLF cohort (P<0.01), but otherwise complication and reoperation rates were similar. Implant cost (P<0.01) and operative time (P=0.01) were higher in the PLF + TLIF cohort. Conclusions The addition of a TLIF to a PLF did not result in a functional improvement in the treatment of degenerative spondylolisthesis as measured by the ODI.
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Austevoll IM, Gjestad R, Grotle M, Solberg T, Brox JI, Hermansen E, Rekeland F, Indrekvam K, Storheim K, Hellum C. Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis. BMC Musculoskelet Disord 2019; 20:31. [PMID: 30658613 PMCID: PMC6339296 DOI: 10.1186/s12891-018-2386-y] [Citation(s) in RCA: 68] [Impact Index Per Article: 11.3] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2017] [Accepted: 12/19/2018] [Indexed: 11/21/2022] Open
Abstract
Background Assessment of outcomes for spinal surgeries is challenging, and an ideal measurement that reflects all aspects of importance for the patients does not exist. Oswestry Disability Index (ODI), EuroQol (EQ-5D) and Numeric Rating Scales (NRS) for leg pain and for back pain are commonly used patients reported outcome measurements (PROMs). Reporting the proportion of individuals with an outcome of clinical importance is recommended. Knowledge of the ability of PROMs to identify clearly improved patients is essential. The purpose of this study was to search cut-off criteria for PROMs that best reflect an improvement considered by the patients to be of clinical importance. Methods The Global Perceived Effect scale was utilized to evaluate a clinically important outcome 12 months after surgery. The cut-offs for the PROMs that most accurately distinguish those who reported ‘completely recovered’ or ‘much improved’ from those who reported ‘slightly improved’, unchanged’, ‘slightly worse’, ‘much worse’, or ‘worse than ever’ were estimated. For each PROM, we evaluated three candidate response parameters: the (raw) follow-up score, the (numerical) change score, and the percentage change score. Results We analysed 3859 patients with Lumbar Spinal Stenosis [(LSS); mean age 66; female gender 50%] and 617 patients with Lumbar Degenerative Spondylolisthesis [(LDS); mean age 67; 72% female gender]. The accuracy of identifying ‘completely recovered’ and ‘much better’ patients was generally high, but lower for EQ-5D than for the other PROMs. For all PROMs the accuracy was lower for the change score than for the follow-up score and the percentage change score, especially among patients with low and high PROM scores at baseline. The optimal threshold for a clinically important outcome was ≤24 for ODI, ≥0.69 for EQ-5D, ≤3 for NRS leg pain, and ≤ 4 for NRS back pain, and, for the percentage change score, ≥30% for ODI, ≥40% for NRS leg pain, and ≥ 33% for NRS back pain. The estimated cut-offs were similar for LSS and for LDS. Conclusion For estimating a ‘success’ rate assessed by a PROM, we recommend using the follow-up score or the percentage change score. These scores reflected a clinically important outcome better than the change score.
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Affiliation(s)
- Ivar Magne Austevoll
- Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland, University Hospital, Hagaviksbakken 25, 5217 Hagevik, Bergen, Norway. .,Department of Clinical Medicine, University of Bergen, Christies gate 6, 5007 Bergen, Bergen, Norway. .,The Norwegian Registry for Spine Surgery (NORspine), Northern Norway Regional Health Authority, Postboks 20, 9038 Tromsø, Bodø, Norway.
| | - Rolf Gjestad
- Research Department, Division of Psychiatry, Haukeland University Hospital, Sanviksleitet 1, 5036 Bergen, Bergen, Norway
| | - Margreth Grotle
- Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital, PB 4950 Nydalen, 0424, Oslo, Oslo, Norway.,Faculty of Health Science, OsloMet - Oslo Metropolitan University, PO box 4 St. Olavs plass, 0130, Oslo, Oslo, Norway
| | - Tore Solberg
- The Norwegian Registry for Spine Surgery (NORspine), Northern Norway Regional Health Authority, Postboks 20, 9038 Tromsø, Bodø, Norway.,Department of Neurosurgery, University Hospital of Northern Norway, Sykehusvegen 38, 90919 Tromsø, Tromsø, Norway
| | - Jens Ivar Brox
- The Norwegian Registry for Spine Surgery (NORspine), Northern Norway Regional Health Authority, Postboks 20, 9038 Tromsø, Bodø, Norway.,Department of Physical Medicine and Rehabilitation, Oslo University Hospital, PB 4950 Nydalen, 0424, Oslo, Oslo, Norway
| | - Erland Hermansen
- Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland, University Hospital, Hagaviksbakken 25, 5217 Hagevik, Bergen, Norway.,Department of Clinical Medicine, University of Bergen, Christies gate 6, 5007 Bergen, Bergen, Norway.,Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway
| | - Frode Rekeland
- Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland, University Hospital, Hagaviksbakken 25, 5217 Hagevik, Bergen, Norway
| | - Kari Indrekvam
- Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland, University Hospital, Hagaviksbakken 25, 5217 Hagevik, Bergen, Norway.,Department of Clinical Medicine, University of Bergen, Christies gate 6, 5007 Bergen, Bergen, Norway
| | - Kjersti Storheim
- Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital, PB 4950 Nydalen, 0424, Oslo, Oslo, Norway
| | - Christian Hellum
- The Norwegian Registry for Spine Surgery (NORspine), Northern Norway Regional Health Authority, Postboks 20, 9038 Tromsø, Bodø, Norway.,Division of Orthopaedic Surgery, Oslo University Hospital, 4950 Nydalen, 0424, Oslo, PB, Norway
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Yuksel S, Ayhan S, Nabiyev V, Domingo-Sabat M, Vila-Casademunt A, Obeid I, Perez-Grueso FS, Acaroglu E. Minimum clinically important difference of the health-related quality of life scales in adult spinal deformity calculated by latent class analysis: is it appropriate to use the same values for surgical and nonsurgical patients? Spine J 2019; 19:71-78. [PMID: 30010046 DOI: 10.1016/j.spinee.2018.07.005] [Citation(s) in RCA: 47] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2018] [Revised: 07/04/2018] [Accepted: 07/05/2018] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Health-related quality of life (HRQOL) parameters have been shown to be reliable and valid in patients with adult spinal deformity (ASD). Minimum clinically important difference (MCID) has become increasingly important to clinicians in evaluating patients with a threshold of improvement that is clinically relevant. PURPOSE To calculate MCID and minimum detectable change (MDC) values of total scores of the Core Outcome Measures Index (COMI), Oswestry Disability Index (ODI), Physical Component Summary (PCS), Mental Component Summary (MCS) of the Short Form 36 (SF-36), and Scoliosis Research Society 22R (SRS-22R) in surgically and nonsurgically treated ASD patients who have completed an anchor question at pretreatment and 1-year follow-up. STUDY DESIGN/SETTING Prospective cohort. PATIENT SAMPLE Surgical and nonsurgical patients from a multicenter ASD database. OUTCOME MEASURES Self-reported HRQOL measures (COMI, ODI, SF-36, SRS-22R, and anchor question). METHODS A total of 185 surgical and 86 nonsurgical patients from a multicenter ASD database who completed pretreatment and 1-year follow-up HRQOL scales and the anchor question at the first year follow-up were included. The anchor question was used to determine MCID for each HRQOL measure. MCIDs were calculated by an anchor-based method using latent class analysis (LCA) and MDCs by a distribution-based method. RESULTS All differences between means of baseline and first year postoperative total score measures for all scales demonstrated statistically significant improvements in the overall population as well as the surgically treated patients but not in the nonsurgical group. The calculated MDC and MCID values of HRQOL parameters in the entire study population were 1.34 and 2.62 for COMI, 10.65 and 14.31 for ODI, 6.09 and 7.33 for SF-36 PCS, 6.14 and 4.37 for SF-36 MCS, and 0.42 and 0.71 for SRS-22R. The calculated MCID values for surgical and non-surgical treatment groups were 2.76 versus 1.20 for COMI, 14.96 versus 2.45 for ODI, 7.83 versus 2.15 for SF-36 PCS, 5.14 versus 2.03 for SF-36 MCS, and 0.94 versus 0.11 for SRS-22R; the MDC values for surgical and nonsurgical treatment groups were 1.22 versus 1.51 for COMI, 10.27 versus 9.45 for ODI, 5.16 versus 6.77 for SF-36 PCS, 6.05 versus 5.67 for SF-36 MCS, and 0.38 versus 0.43 for SRS-22R. CONCLUSIONS This study has demonstrated that MCID calculations for the HRQOL scales in ASD using LCA yield values comparable to other studies that had used different methodologies. The most important finding was the significantly different MCIDs for COMI, ODI, SF-36 PCS and SRS-22 in the surgically and nonsurgically treated cohorts. This finding suggests that a universal MCID value, inherent to a specific HRQOL for an entire cohort of ASD may not exist. Use of different MCIDs for surgical and nonsurgical patients may be warranted.
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Affiliation(s)
- Selcen Yuksel
- Department of Biostatistics, Yildirim Beyazit University, Ankara, Turkey
| | - Selim Ayhan
- ARTES Spine Center, Ankara, Turkey; Vocational School of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey
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- Hospital Universitari Vall d'Hebron, Barcelona, Spain
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Panchal R, Denhaese R, Hill C, Strenge KB, DE Moura A, Passias P, Arnold P, Cappuccino A, Dennis MD, Kranenburg A, Ventimiglia B, Martin K, Ferry C, Martineck S, Moore C, Kim K. Anterior and Lateral Lumbar Interbody Fusion With Supplemental Interspinous Process Fixation: Outcomes from a Multicenter, Prospective, Randomized, Controlled Study. Int J Spine Surg 2018; 12:172-184. [PMID: 30276077 DOI: 10.14444/5025] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/26/2023] Open
Abstract
Background Rigid interspinous process fixation (ISPF) has received consideration as an efficient, minimally disruptive technique in supporting lumbar interbody fusion. However, despite advantageous intraoperative utility, limited evidence exists characterizing midterm to long-term clinical outcomes with ISPF. The objective of this multicenter study was to prospectively assess patients receiving single-level anterior (ALIF) or lateral (LLIF) lumbar interbody fusion with adjunctive ISPF. Methods This was a prospective, randomized, multicenter (11 investigators), noninferiority trial. All patients received single-level ALIF or LLIF with supplemental ISPF (n = 66) or pedicle screw fixation (PSF; n = 37) for degenerative disc disease and/or spondylolisthesis (grade ≤2). The randomization patient ratio was 2:1, ISPF/PSF. Perioperative and follow-up outcomes were collected (6 weeks, 3 months, 6 months, and 12 months). Results For ISPF patients, mean posterior intraoperative outcomes were: blood loss, 70.9 mL; operating time, 52.2 minutes; incision length, 5.5 cm; and fluoroscopic imaging time, 10.4 seconds. Statistically significant improvement in patient Oswestry Disability Index scores were achieved by just 6 weeks after operation (P < .01) and improved out to 12 months for the ISPF cohort. Patient-reported 36-Item Short Form Health Survey and Zurich Claudication Questionnaire scores were also significantly improved from baseline to 12 months in the ISPF cohort (P < .01). A total of 92.7% of ISPF patients exhibited interspinous fusion at 12 months. One ISPF patient (1.5%) required a secondary surgical intervention of possible relation to the posterior instrumentation/procedure. Conclusion ISPF can be achieved quickly, with minimal tissue disruption and complication. In supplementing ALIF and LLIF, ISPF supported significant improvement in early postoperative (≤12 months) patient-reported outcomes, while facilitating robust posterior fusion.
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Affiliation(s)
- Ripul Panchal
- University of California Davis Health System, Sacramento, California
| | - Ryan Denhaese
- AXIS Neurosurgery and Spine, Williamsville, New York
| | - Clint Hill
- The Orthopaedic Institute, Paducah, Kentucky
| | | | | | | | - Paul Arnold
- Department of Neurosurgery, University of Kansas, Kansas City, Kansas
| | | | | | | | | | - Kim Martin
- Zimmer Biomet Spine, Broomfield, Colorado
| | | | | | | | - Kee Kim
- University of California Davis Health System, Sacramento, California
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