|
1
|
Soda M, Moatz B, Asdourian P, Brooks D, Cunningham B, McAfee PC. Three-Dimensional Printed Anterior Cervical Standalone Combined Cage-Plate-300 Consecutive Medical Implants. J Am Acad Orthop Surg Glob Res Rev 2025; 9:01979360-202505000-00018. [PMID: 40388475 PMCID: PMC12086781 DOI: 10.5435/jaaosglobal-d-24-00245] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2024] [Revised: 12/11/2024] [Accepted: 03/23/2025] [Indexed: 05/21/2025]
Abstract
OBJECTIVE The primary objective was to investigate the perioperative parameters and clinical outcomes of a novel three-dimensional (3D) printed titanium interbody spacer and integral screws. The secondary objective was to compare the survivorship rate of the 3D-printed titanium integrated spacer (3D-printed spacer group) with that of a polyether-ether-ketone (PEEK) integrated spacer (PEEK group) and traditional allograft spacer combined with an anterior cervical plate (control group). STUDY DESIGN This is a retrospective study comprising 157 consecutive patients (representing 300 surgical levels) investigating the perioperative and clinical outcomes of a novel 3D-printed titanium integrated spacer for anterior cervical diskectomy and fusion (ACDF). METHODS A consecutive series of 157 patients (N = 300 surgical levels) presenting with cervical radiculopathy, myelopathy, or spondylosis underwent ACDF with the 3D-printed titanium spacer. Perioperative outcomes including surgical time, estimated blood loss, length of hospital stay, and number of surgical levels were collected. Clinical outcomes including the American Spinal Injury Association neurologic impairment score and Neck Disability Index (NDI) were measured preoperatively and postoperatively. Survivorship was defined as no failures, no anterior revision surgeries, no instrumentation removals, and no subsidence requiring surgery. RESULTS The mean surgical time for the 3D-printed spacer group was 126.3 ± 34.0 minutes, the estimated blood loss was 85.9 ± 30.5 cc, and the length of hospital stay was 1.5 ± 1.4 days. Surgical levels were distributed as follows: 33.8% single-level, 42.7% two-level, 21.6% three-level, and 1.9% four-level ACDF procedures. 98.7% of patients in the 3D-printed spacer group reported improved American Spinal Injury Association scores. The mean NDI preoperatively was 37.2 ± 18.7, and the mean NDI postoperatively was 21.2 ± 18.3, with 58.6% of patients reporting NDI improvement of 15% or greater. Survivorship was observed in 97.4% of patients in the 3D-printed spacer group, 98.0% in the PEEK group, and 93.3% in the control group (chi-square analysis: X2 [1, N = 1529] = 16.9, P = 0.0002). CONCLUSION A novel 3D-printed titanium spacer with integral screws for ACDF demonstrated improved survivorship rates compared with the traditional allograft spacer and anterior plate. Among 157 patients, only two required supplemental posterior fixation, one required removal for excessive kyphosis and were successfully revised with a 3D-printed corpectomy spacer, and one had notable subsidence at 6 weeks postoperatively (4 total failures based on the survivorship criteria; 97.4% survivorship success rate (153/157 patients)). Not a single case of neurologic progression was observed in the 3D-printed spacer group-no iatrogenic progressive radiculopathy nor myelopathy, unlike the control group.
Collapse
Affiliation(s)
- Mosope Soda
- From the Department of Orthopaedic Surgery, MedStar Union Memorial Medical Center, Baltimore, MD
| | - Bradley Moatz
- From the Department of Orthopaedic Surgery, MedStar Union Memorial Medical Center, Baltimore, MD
| | - Paul Asdourian
- From the Department of Orthopaedic Surgery, MedStar Union Memorial Medical Center, Baltimore, MD
| | - Daina Brooks
- From the Department of Orthopaedic Surgery, MedStar Union Memorial Medical Center, Baltimore, MD
| | - Bryan Cunningham
- From the Department of Orthopaedic Surgery, MedStar Union Memorial Medical Center, Baltimore, MD
| | - Paul C. McAfee
- From the Department of Orthopaedic Surgery, MedStar Union Memorial Medical Center, Baltimore, MD
| |
Collapse
|
|
2
|
Nilssen PK, Shafi K, Narendran N, Farivar D, Nomoto E, Mikhail C, Lanman T, Kim SD. Complications and reoperations in young versus old patients undergoing cervical disc arthroplasty. NORTH AMERICAN SPINE SOCIETY JOURNAL 2025; 21:100589. [PMID: 40034338 PMCID: PMC11875681 DOI: 10.1016/j.xnsj.2025.100589] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/17/2024] [Revised: 01/15/2025] [Accepted: 01/16/2025] [Indexed: 03/05/2025]
Abstract
Background Despite the growing popularity of cervical disc arthroplasty (CDA), there remains a lack of literature investigating outcomes in older patients and no consensus exists on an age threshold beyond which CDA is not recommended. This study aimed to compare outcomes between patients younger than 65 and those aged 65 and older undergoing CDA. Methods Patients who underwent CDA at a major spine center (January 2009-December 2023), with at least 1 year of follow-up, were included. Two age-based cohorts were analyzed: younger (<65) and older (≥65). Both single and multilevel disc replacements were considered. Primary outcomes included comparing 90-day complications and all-cause reoperation rates in the 2 cohorts. Secondary outcomes included comparisons of patient characteristics, operative data, and length of stay (LOS). Frequencies, chi-squared analysis, and Student's t-test were used to compare cohorts. Results A total of 298 CDAs were evaluated among 188 patients. There were 132 patients in the younger cohort (mean age: 48.9±10.2) and 56 in the older cohort (mean age: 69.5±3.8). Cohorts were similar with regards to body mass index, sex, and length of follow up. The overall 90-day complication rate was 23.8%. There was no difference in complication rates (younger: 23.3%, older: 25.0%, p=.60). Older cohort averaged more levels operated (older 1.8±0.6, younger 1.5±0.7, p=.006). The overall reoperation rate was 12.2% (young: 13.5%, older: 8.9%, p=.38). Subsidence was the most common cause of reoperation in both the younger (n=4, 3.0%) and older (n=2, 3.6%) cohorts. Conclusion In this series, we found no statistically significant differences in 90-day complication or reoperation rates between younger (<65 years) and older (≥65 years) patients undergoing CDA. Subsidence emerged as the most common complication, occurring at similar rates in both cohorts. While further large-scale, long-term analysis is warranted to determine clinical outcomes of CDA in older patients, this study provides comparable complication and reoperation rates as in the younger population.
Collapse
Affiliation(s)
- Paal K. Nilssen
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Karim Shafi
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Nakul Narendran
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Daniel Farivar
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Edward Nomoto
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Christopher Mikhail
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Todd Lanman
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| | - Sang Do Kim
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States
| |
Collapse
|
|
3
|
Nilssen PK, Narendran N, Chen I, Kanim LE, Walker CT, Bae HW, Skaggs DL, Tuchman A. Risk Factors for Reoperation Following Single-Level Cervical Disc Arthroplasty as Utilized in a Representative Sample of United States Clinical Practice: A Retrospective PearlDiver Study. Global Spine J 2025; 15:1186-1192. [PMID: 38279691 PMCID: PMC11572117 DOI: 10.1177/21925682241230965] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/28/2024] Open
Abstract
STUDY DESIGN Retrospective Cohort. OBJECTIVES Most data regarding cervical disc arthroplasty (CDA) outcomes are from highly controlled clinical trials with strict inclusion/exclusion criteria. This study aimed to identify risk factors for CDA reoperation, in "real world" clinical practice using a national insurance claims database. METHODS The PearlDiver database was queried for patients (2010-2020) who underwent a subsequent cervical procedure following a single-level CDA. Patients with less than 2 years follow-up were excluded. Primary outcome was to evaluate risk factors for reoperation. Secondary outcome was to evaluate the types of reoperations. Risk factors were compared using descriptive statistics. Multivariate regression analyses were used to ascertain the association among risk factors and reoperation. RESULTS Of 14,202 patients who met inclusion criteria, 916 (6.5%) underwent reoperation. Patients undergoing reoperation were slightly older with higher Elixhauser Comorbidity Index (ECI) scores, however both were not risk factors for reoperation. Patients with diagnoses such as smoking, myelopathy, inflammatory disorders, spinal deformity, trauma, or a history of prior cervical surgery were at greater risk for reoperation. No association was found between the year of index surgery and reoperation risk. The most common reoperation procedure was cervical fusion. CONCLUSIONS As billed for in the United States since 2010, CDA was associated with a 6.5% reoperation rate over a mean follow-up time of 5.3 years. Smoking, myelopathy, inflammatory disorders, spinal deformity, and a history of prior cervical surgery or trauma are risk factors for reoperation following CDA. Though patients who underwent a reoperation were older, age was not found to be an independent risk factor for a subsequent procedure.
Collapse
Affiliation(s)
- Paal K. Nilssen
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Nakul Narendran
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Ida Chen
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Linda E. Kanim
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Corey T. Walker
- Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Hyun W. Bae
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - David L. Skaggs
- Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Alexander Tuchman
- Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| |
Collapse
|
|
4
|
Huang Y, Du D, Tian J, Chou D, Chen L, Feng H, Liu J. Long-term outcomes of anterior cervical dynamic implants: motion-sparing or a delayed fusion? Spine J 2025; 25:244-254. [PMID: 39349258 DOI: 10.1016/j.spinee.2024.09.006] [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: 03/18/2024] [Revised: 09/09/2024] [Accepted: 09/14/2024] [Indexed: 10/02/2024]
Abstract
BACKGROUND CONTEXT Use of an anterior cervical dynamic implant (ACDI) is generally considered a nonfusion technique for treating cervical degenerative disorders. However, there is limited research focused on evaluating the long-term clinical and radiographic outcomes of ACDI. PURPOSE To analyze the long-term clinical and radiographic outcomes of ACDI in the treatment of degenerative cervical disorders. STUDY DESIGN A retrospective cohort study. PATIENTS SAMPLE Patients with degenerative cervical disorders who underwent anterior cervical discectomy and dynamic cervical implant (DCI) implantation between May 2012 and August 2020 at our institution were included in this study. OUTCOME MEASURES Clinical outcomes were assessed using the modified Japanese Orthopedic Association (mJOA), visual analog scale (VAS) scores and patient reported satisfaction rate. Imaging assessment parameters included intervertebral height (IH), intervertebral disc height (IDH), C2-7 range of motion (ROM), segmental ROM, the degree of DCI subsidence and anterior migration, heterotopic ossification (HO) as well as adjacent segment degeneration (ASD). METHODS JOA and VAS scores were obtained through questionnaire. The patient reported satisfaction was rated as very satisfied, satisfied, less satisfied and dissatisfied at the final follow-up. The position of the implants, IDH and IH were evaluated on lateral radiographs. ROM at C2-7, ROM at operated level were measured on dynamic radiographs. Cervical 3-dimensional computer tomography (CT) and magnetic resonance image (MRI) images were used to assess the presence of HO and ASD. The clinical and radiologic variables between the preoperative period and different follow-up time point were statistically analyzed by unpaired t-tests or chi-square tests. Statistical significance was defined as p<.05. RESULTS A total of 92 patients (51 males and 41 females) were included in this study. Among them, there were 36 cases of cervical spondylotic myelopathy, 26 cases of cervical radiculopathy, and 30 cases of myeloradiculopathy. The mean age was 55.1±12.6 years. The number of operated levels was single level in 57 patients, 2 levels in 31 patients, and 3 levels in 4 patients. The average follow-up period was 81.3 months (range: 35-135 months). The mean JOA scores showed a gradual increase at 1 month, 1 year, and the final follow-up (12.0±0.7,13.5±0.8, and14.4±1.1 respectively) compared to the preoperative score (9.1±0.9, p<.01). VAS scores significantly decreased at 1 month, 1 year, and the final follow-up (4.1±0.7, 2.3±0.9, and 2.0±0.8 respectively) compared to the preoperative score (7.2±l .2, p<.01). At the final follow-up, the patient reported satisfaction was rated as very satisfied, satisfied, less satisfied and dissatisfied (79%, 10%, 10%, 1% respectively). Revision surgery was not required for any of the patients during the follow-up period, either due to instrumentation failure or adjacent segmental diseases. In the radiographic assessment, there was a notable increase in IH and IDH after surgery compared to preoperative values (33.0±4.0 mm vs 30.7±3.0 mm, p<.01 and 6.7±2.4 mm vs 4.6±0.9 mm, p<.01 respectively), which gradually decreased at 1 year and the final follow-up (IH: 32.1±2.5 vs 30.9±3.5 p=.024; IDH: 5.3±1.5 mm vs 4.3±0.6 mm, p=.043 respectively). At the 1-month postoperative follow-up, the segmental ROM exhibited a decrease compared with preoperative values (6.2±1.8° vs 7.5±2.0° p=.044), followed by an increase at the 1-year follow-up (6.2±1.8° vs 6.4±1.5° p=.078), but ultimately decreased at the final follow-up (6.4±1.5° vs 2.9±0.6°, p<.01). HO was observed in approximately 81.5% of cases (75/92), while a great proportion (41.3%) of patients experienced varying degrees of prosthesis subsidence and anterior migration during the follow-up. CONCLUSIONS At the long-term follow-up, a high incidence of HO, along with varying degrees of subsidence and migration of the prosthesis, were observed in most patients. As the motion preservation capability of the ACDI gradually diminishes, delayed intervertebral autofusion becomes a more likely outcome compared to motion sparing.
Collapse
Affiliation(s)
- Yukai Huang
- Department of Neurosurgery, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and technology of China, Chengdu, China
| | - Dingyu Du
- Department of Neurosurgery, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and technology of China, Chengdu, China
| | - Jie Tian
- Department of Neurosurgery, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and technology of China, Chengdu, China
| | - Dean Chou
- Department of Neurosurgery, Columbia University, New York, USA
| | - Longyi Chen
- Department of Neurosurgery, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and technology of China, Chengdu, China
| | - Hailong Feng
- Department of Neurosurgery, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and technology of China, Chengdu, China; Department of Neurosurgery, Xiqu hospital of Chengdu, Sichuan, China
| | - Jinping Liu
- Department of Neurosurgery, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and technology of China, Chengdu, China.
| |
Collapse
|
|
5
|
Patel S, Schupper AJ, Ezzat B, Asfaw Z, Yuk FJ, Stein A, Choudhri TF. The Top 100 Cited Articles on Cervical Disc Arthroplasty: A Bibliometric Analysis. Clin Spine Surg 2024; 37:E522-E528. [PMID: 38679817 DOI: 10.1097/bsd.0000000000001636] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/12/2023] [Accepted: 03/11/2024] [Indexed: 05/01/2024]
Abstract
STUDY DESIGN Bibliometric analysis. OBJECTIVE Cervical disc arthroplasty (CDA) has emerged as an effective surgical intervention for degenerative cervical disc disease with potential advantages over traditional cervical fusion. This bibliometric analysis aimed to assess the current state of research on CDA by analyzing the relevant literature using bibliometric indicators. SUMMARY OF BACKGROUND DATA Web of Science Core Collection. METHODS A comprehensive search was conducted using the Web of Science database, for articles related to CDA published in the last 19 years. The top 100 articles were reviewed using bibliometric analysis. Publication trends, citation patterns, authorship, and collaboration networks were analyzed using VOSviewer and the Bibliometrix package in RStudio. RESULTS The results revealed a significant increase in the number of publications related to CDA over the past 2 decades, with most of the articles being published in orthopedic and spine surgery journals. The most frequently cited articles were related to clinical outcomes, complications, and biomechanical studies of CDA. Co-authorship analysis identified influential authors and collaborative networks, highlighting the multidisciplinary nature of CDA research involving neurosurgeons, orthopedic surgeons, and engineers. Overall, this bibliometric analysis provides a comprehensive overview of the current state of research on CDA, highlighting the key research themes, influential authors, and collaborative networks in the field. CONCLUSION These findings can serve as a guide for researchers, clinicians, and policymakers to identify knowledge gaps, research trends, and future directions in the field of CDA.
Collapse
Affiliation(s)
- Shrey Patel
- Tufts University School of Medicine, Boston, MA
| | - Alexander J Schupper
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY
| | - Bahie Ezzat
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY
| | - Zerubabbel Asfaw
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY
| | - Frank J Yuk
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY
| | - Alan Stein
- Department of Neurosurgery, Westchester Medical Center, Valhalla, NY
| | - Tanvir F Choudhri
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY
| |
Collapse
|
|
6
|
Arroyave JS, Restrepo Mejia M, Ahmed W, Rajjoub R, Poeran J, Stern BZ, Chaudhary SB. Racial Disparities in Utilization and Outcomes of Cervical Disc Arthroplasty. Clin Spine Surg 2024:01933606-990000000-00392. [PMID: 39508849 DOI: 10.1097/bsd.0000000000001714] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/29/2024] [Accepted: 09/23/2024] [Indexed: 11/15/2024]
Abstract
STUDY DESIGN Retrospective study. OBJECTIVE We examined racial disparities in (1) cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) utilization and (2) CDA in-hospital outcomes. SUMMARY OF BACKGROUND DATA ACDF and CDA are established treatments for cervical disc disease. While CDA may offer certain advantages over ACDF, its utilization patterns have not been comprehensively explored. METHODS This study of 2012 to 2019 discharges from the National Inpatient Sample included White, Black, and Hispanic patients aged 18 years and older who underwent elective ACDF or CDA. Patient demographics, comorbidities, cervical spine diagnoses, and hospital characteristics were extracted. Survey-weighted logistic regression modeled the adjusted association between race and CDA (vs. ACDF) utilization; an interaction between race and year examined temporal changes in disparities. For CDA outcomes, multivariable logistic regression was used for binary outcomes (nonhome discharge, combined complications, and dysphagia) and linear regression for length of stay. RESULTS The cohort included 712,355 weighted procedures (97.6% ACDF; 84.2% White, 9.7% Black, 6.1% Hispanic). CDA utilization increased from 1.0% of the procedures in 2012 to 3.8% in 2019. Black and Hispanic patients had significantly lower odds than White patients of receiving CDA versus ACDF (OR=0.77, 95% CI: 0.66-0.89, P=0.001; OR=0.80, 95% CI: 0.69-0.93, P=0.003) respectively. There was no statistically significant interaction between race and discharge year (P=0.50). For in-hospital CDA-specific outcomes, Black (vs. White) patients were more likely to experience dysphagia (OR=2.70, 95% CI: 1.53-4.78, P=0.001) and combined complications (OR=3.10, 95% CI: 1.91-5.05, P <0.001). There were no significant differences in any CDA outcome for Hispanic versus White patients. CONCLUSIONS This study revealed decreased utilization of CDA versus ACDF in minority patients, a pattern that persisted over time despite overall increasing CDA utilization. In addition, a higher burden of dysphagia and combined complications following CDA in Black patients warrants further examination. LEVEL OF EVIDENCE III.
Collapse
Affiliation(s)
| | | | - Wasil Ahmed
- Leni and Peter W. May Department of Orthopaedics
| | - Rami Rajjoub
- Leni and Peter W. May Department of Orthopaedics
| | - Jashvant Poeran
- Leni and Peter W. May Department of Orthopaedics
- Department of Population Health Science and Policy, Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York, NY
| | - Brocha Z Stern
- Leni and Peter W. May Department of Orthopaedics
- Department of Population Health Science and Policy, Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York, NY
| | | |
Collapse
|
|
7
|
Altorfer FCS, Kelly MJ, Avrumova F, Zhu J, Abjornson C, Lebl DR. Reasons for Revision Surgery After Cervical Disk Arthroplasty Based on Medical Device Reports Maintained by the US Food and Drug Administration. Spine (Phila Pa 1976) 2024; 49:1417-1425. [PMID: 38819199 DOI: 10.1097/brs.0000000000005060] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/25/2024] [Accepted: 05/20/2024] [Indexed: 06/01/2024]
Abstract
STUDY DESIGN Retrospective database review. OBJECTIVE The aim of this study was to analyze revisions of CDAs reported to the MAUDE database. SUMMARY OF BACKGROUND DATA Cervical disk arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs. METHODS The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared. RESULTS A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify. CONCLUSIONS The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification, varying in their rerelvance depending on the CDA. LEVEL OF EVIDENCE Level II.
Collapse
Affiliation(s)
| | - Michael J Kelly
- Department of Spine Surgery, Hospital for Special Surgery, New York, NY
| | - Fedan Avrumova
- Department of Spine Surgery, Hospital for Special Surgery, New York, NY
| | - Jiaqi Zhu
- Biostatistics Core, Hospital for Special Surgery, New York, NY
| | - Celeste Abjornson
- Department of Spine Surgery, Hospital for Special Surgery, New York, NY
| | - Darren R Lebl
- Department of Spine Surgery, Hospital for Special Surgery, New York, NY
| |
Collapse
|
|
8
|
Proal JD, Moon AS, Kwon B. The fragility index and reverse fragility index of FDA investigational device exemption trials in spinal fusion surgery: a systematic review. 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 2024; 33:2594-2603. [PMID: 38802596 DOI: 10.1007/s00586-024-08317-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/09/2024] [Revised: 04/20/2024] [Accepted: 05/16/2024] [Indexed: 05/29/2024]
Abstract
PURPOSE FDA investigational device exemption (IDE) studies are considered a gold standard of assessing safety and efficacy of novel devices through RCTs. The fragility index (FI) has emerged as a means to assess robustness of statistically significant study results and inversely, the reverse fragility index (RFI) for non-significant differences. Previous authors have defined results as fragile if loss to follow up is greater than the FI or RFI. The aim of this study was to assess the FI, RFI, and robustness of data supplied by IDE studies in spinal surgery. METHODS This was a systematic review of the literature. Inclusion criteria included randomized controlled trials with dichotomous outcome measures conducted under IDE guidelines between 2000 and 2023. FI and RFI were calculated through successively changing events to non-events until the outcome changed to non-significance or significance, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ) were calculated by dividing the FI and RFI, respectively, by the sample size. RESULTS Thirty-two studies met inclusion criteria with a total of 40 unique outcome measures; 240 outcomes were analyzed. Twenty-six studies reported 96 statistically significant results. The median FI was 6 (IQR: 3-9.25), and patients lost to follow up was greater than the FI in 99.0% (95/96) of results. The average FQ was 0.027. Thirty studies reported 144 statistically insignificant results and a median RFI of 6 (IQR: 4-8). The average RFQ extrapolated was 0.021, and loss to follow up was greater than the RFI in 98.6% (142/144) of results. CONCLUSIONS IDE studies in spine surgery are surprisingly fragile given their reputations, large sample sizes, and intent to establish safety in investigational devices. This study found a median FI and RFI of 6. The number of patients lost to follow-up was greater than FIand RFI in 98.8% (237/240) of reported outcomes. FQ and RFQ tell us that changes of two to three patients per hundred can flip the significance of reported outcomes. This is an important reminder of the limitations of RCTs. Analysis of fragility in future studies may help clarify the strength of the relationship between reported data and their conclusions.
Collapse
Affiliation(s)
- Joshua D Proal
- Tufts University School of Medicine, 145 Harrison Ave, Boston, MA, 02111, USA.
| | - Andrew S Moon
- Department of Orthopedic Surgery, Tufts Medical Center, Tufts University School of Medicine, 800 Washington St, Tufts MC Box #306, Boston, MA, 02111, USA
| | - Brian Kwon
- New England Baptist Hospital, Department of Orthopaedic Surgery, 125 Parker Hill Ave, Boston, MA, 02120, USA
| |
Collapse
|
|
9
|
Megafu EC, Megafu MN, Nguyen JT, Du Jour EP, Bronson WH, Lin JD, Hecht AC, Parisien RL. The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials. Arch Orthop Trauma Surg 2024; 144:2609-2617. [PMID: 38700676 PMCID: PMC11211173 DOI: 10.1007/s00402-024-05353-y] [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: 03/06/2024] [Accepted: 04/26/2024] [Indexed: 06/29/2024]
Abstract
PURPOSE This study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability. METHODS A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3-7) and 0.019 (IQR 0.011-0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5. CONCLUSIONS The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.
Collapse
Affiliation(s)
| | - Michael N Megafu
- A.T. Still University, Kirksville College of Osteopathic Medicine, Kirksville, MO, USA.
| | - Janet T Nguyen
- Geisinger Commonwealth School of Medicine, Scranton, PA, USA
| | | | - Wesley H Bronson
- Department of Orthopedic Surgery, Mount Sinai Hospital, New York, NY, USA
| | - James D Lin
- Department of Orthopedic Surgery, Mount Sinai Hospital, New York, NY, USA
| | - Andrew C Hecht
- Department of Orthopedic Surgery, Mount Sinai Hospital, New York, NY, USA
| | - Robert L Parisien
- Department of Orthopedic Surgery, Mount Sinai Hospital, New York, NY, USA
| |
Collapse
|
|
10
|
Miller AK, Zakko P, Park DK, Chang VW, Schultz L, Springer K, Hamilton TM, Abdulhak MM, Schwalb JM, Nerenz DR, Aleem IS, Khalil JG. Cervical disc arthroplasty versus anterior cervical discectomy and fusion: an analysis of the Michigan Spine Surgery Improvement Collaborative Database. Spine J 2024; 24:791-799. [PMID: 38110089 DOI: 10.1016/j.spinee.2023.12.004] [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: 08/05/2023] [Revised: 11/08/2023] [Accepted: 12/14/2023] [Indexed: 12/20/2023]
Abstract
BACKGROUND CONTEXT Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) are established surgical options for the treatment of cervical radiculopathy, myelopathy, and cervical degenerative disc disease. However, current literature does not demonstrate a clear superiority between ACDF and CDA. PURPOSE To investigate procedural and patient-reported outcomes of ACDF and CDA among patients included in the Michigan Spine Surgery Improvement Collaborative (MSSIC) database. DESIGN Retrospective study of prospectively collected outcomes registry data. PATIENT SAMPLE Individuals within the MSSIC database presenting with radiculopathy, myelopathy, or cervical spondylosis refractory to typical conservative care undergoing primary ACDF or CDA from January 4, 2016, to November 5, 2021. OUTCOME MEASURES Perioperative measures (including surgery length, length of stay, return to OR, any complications), patient-reported functional outcomes at 2-year follow-up (including return to work, patient satisfaction, PROMIS, EQ-5D, mJOA). METHODS Patients undergoing ACDF were matched 4:1 with those undergoing CDA; propensity analysis performed on operative levels (1- and 2- level procedures), presenting condition, demographics, and comorbidities. Initial comparisons performed with univariate testing and multivariate analysis performed with Poisson generalized estimating equation models clustering on hospital. RESULTS A total of 2,208 patients with ACDF and 552 patients with CDA were included. Baseline demographics were similar, with younger patients undergoing CDA (45.6 vs 48.6 years; p<.001). Myelopathy was more frequent in ACDF patients (30% vs 25%; p=.015). CDA was more frequently planned as an outpatient procedure. Length of stay was increased in ACDF (1.3 vs 1.0 days; p<.001). Functional outcomes were similar, with comparable proportions of patients meeting minimal clinically important difference thresholds in neck pain, arm pain, PROMIS, EQ-5D, and mJOA score. After multivariate regression, no significant differences were seen in surgical or functional outcomes. CONCLUSIONS This study demonstrates similar outcomes for those undergoing ACDF and CDA at 2 years. Previous meta-analyses of CDA clinical trial data adhere to strict inclusion and exclusion criteria required by clinical studies; this registry data provides "real world" clinical outcomes reflecting current practices for ACDF and CDA patient selection.
Collapse
Affiliation(s)
- Alex K Miller
- Department of Orthopaedic Surgery, Corewell Health East William Beaumont University Hospital, 3601 W. 13 Mile Rd., Royal Oak, MI 48073, USA.
| | - Philip Zakko
- Department of Orthopaedic Surgery, Corewell Health East William Beaumont University Hospital, 3601 W. 13 Mile Rd., Royal Oak, MI 48073, USA
| | - Daniel K Park
- Department of Orthopaedic Surgery, Corewell Health East William Beaumont University Hospital, 3601 W. 13 Mile Rd., Royal Oak, MI 48073, USA; Oakland University William Beaumont School of Medicine, 586 Pioneer Dr., Rochester, MI 48309, USA
| | - Victor W Chang
- Department of Neurosurgery, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, MI 48202, USA
| | - Lonni Schultz
- Michigan Spine Surgery Improvement Collaborative, 3A Ford Pl., Detroit, MI 48202, USA
| | - Kylie Springer
- Michigan Spine Surgery Improvement Collaborative, 3A Ford Pl., Detroit, MI 48202, USA
| | - Travis M Hamilton
- Department of Neurosurgery, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, MI 48202, USA
| | - Muwaffak M Abdulhak
- Department of Neurosurgery, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, MI 48202, USA; Michigan Spine Surgery Improvement Collaborative, 3A Ford Pl., Detroit, MI 48202, USA
| | - Jason M Schwalb
- Department of Neurosurgery, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, MI 48202, USA; Michigan Spine Surgery Improvement Collaborative, 3A Ford Pl., Detroit, MI 48202, USA
| | - David R Nerenz
- Department of Neurosurgery, Henry Ford Hospital, 2799 West Grand Blvd., Detroit, MI 48202, USA; Michigan Spine Surgery Improvement Collaborative, 3A Ford Pl., Detroit, MI 48202, USA
| | - Ilyas S Aleem
- Department of Orthopaedic Surgery, University of Michigan, 1500 E Medical Center Dr., Ann Arbor, MI 48109, USA
| | - Jad G Khalil
- Department of Orthopaedic Surgery, Corewell Health East William Beaumont University Hospital, 3601 W. 13 Mile Rd., Royal Oak, MI 48073, USA; Oakland University William Beaumont School of Medicine, 586 Pioneer Dr., Rochester, MI 48309, USA
| |
Collapse
|
|
11
|
Raso J, Kamalapathy PN, Mo K, Labaran L, Wang J, Solomon E, Hassanzadeh H. No Difference in Two-Year Revisions Between Hybrid Fusion and Two-Level Anterior Discectomy and Fusion: A National Database Study. Global Spine J 2024; 14:949-955. [PMID: 36259613 PMCID: PMC11192127 DOI: 10.1177/21925682221131548] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
Abstract
STUDY DESIGN Retrospective Cohort. OBJECTIVE This study utilized a large national database to compare two-year revision rates, in addition to complications and costs, of hybrid surgery (HS) compared to two-level anterior cervical discectomy and fusion (ACDF). METHODS This study used the PearlDiver Mariner dataset selecting for patients aged 18 and older who had at least 90-day active longitudinal follow-up who underwent two-level ACDF or two-level Hybrid surgery (single level ACDF and single level CDA). Patients with prior spinal trauma, infection, cancer, or posterior fusion were excluded. Primary outcomes measures were 90-day major and minor medical complications, ED visits, readmissions, as well as two-year revisions. Patients were also assessed for postoperative dysphagia, incidental durotomy, vascular injury, 90-day surgical site, and implant complications. Additionally, hospitalization and postoperative costs were evaluated. RESULTS There were 4570 two-level ACDF surgeries and 888 hybrid surgeries. After matching the cohorts, no statistical differences in demographics were found. There were no differences in reoperation rates at all measured time points nor 2-year complications. HS had a lower incidence of major (1.6% vs 3.1%, P = .003) and minor complications (3.0% vs 4.6%, P = .009) than ACDF. 90-day readmission was lower in the HS cohort (2.8% vs 4.2%), P = .024. HS was associated with reduced hospitalization costs -$2614 (-$3916 to -$904, P < .001). 3516 patients had ACDF, and 699 had HS with at least 2 years of follow-up. CONCLUSION Hybrid surgery is a safe and effective surgical treatment for cervical disease in appropriately selected patients.
Collapse
Affiliation(s)
- Jon Raso
- Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA
| | | | - Kevin Mo
- Department of Orthopaedic Surgery, Johns Hopkins University National Capital Region, Bethesda, MD, USA
| | - Lawal Labaran
- Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA
| | - Jesse Wang
- Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA
| | - Eric Solomon
- Department of Orthopaedic Surgery, Johns Hopkins University National Capital Region, Bethesda, MD, USA
| | - Hamid Hassanzadeh
- Departmant of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD, USA
| |
Collapse
|
|
12
|
Mai E, Shahi P, Lee R, Shinn DJ, Vaishnav A, Araghi K, Singh N, Maayan O, Tuma OC, Pajak A, Asada T, Korsun MK, Singh S, Kim YE, Louie PK, Huang RC, Albert TJ, Dowdell J, Sheha ED, Iyer S, Qureshi SA. Risk factors for failure to achieve minimal clinically important difference following cervical disc replacement. Spine J 2023; 23:1808-1816. [PMID: 37660897 PMCID: PMC11620183 DOI: 10.1016/j.spinee.2023.08.017] [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: 03/27/2023] [Revised: 08/24/2023] [Accepted: 08/29/2023] [Indexed: 09/05/2023]
Abstract
BACKGROUND CONTEXT While cervical disc replacement (CDR) has been emerging as a reliable and efficacious treatment option for degenerative cervical spine pathology, not all patients undergoing CDR will achieve minimal clinically important difference (MCID) in patient-reported outcome measures (PROMs) postoperatively-risk factors for failure to achieve MCID in PROMs following CDR have not been established. PURPOSE To identify risk factors for failure to achieve MCID in Neck Disability Index (NDI, Visual Analog Scale (VAS) neck and arm following primary 1- or 2-level CDRs in the early and late postoperative periods. STUDY DESIGN Retrospective review of prospectively collected data. PATIENT SAMPLE Patients who had undergone primary 1- or 2-level CDR for the treatment of degenerative cervical pathology at a single institution with a minimum follow-up of 6 weeks between 2017 and 2022. OUTCOME MEASURES Patient-reported outcomes: Neck disability index (NDI), Visual analog scale (VAS) neck and arm, MCID. METHODS Minimal clinically important difference achievement rates for NDI, VAS-Neck, and VAS-Arm within early (within 3 months) and late (6 months to 2 years) postoperative periods were assessed based on previously established thresholds. Multivariate logistic regressions were performed for each PROM and evaluation period, with failure to achieve MCID assigned as the outcome variable, to establish models to identify risk factors for failure to achieve MCID and predictors for achievement of MCID. Predictor variables included in the analyses featured demographics, comorbidities, diagnoses/symptoms, and perioperative characteristics. RESULTS A total of 154 patients met the inclusion criteria. The majority of patients achieved MCID for NDI, VAS-Neck, and VAS-Arm for both early and late postoperative periods-79% achieved MCID for at least one of the PROMs in the early postoperative period, while 80% achieved MCID for at least one of the PROMs in the late postoperative period. Predominant neck pain was identified as a risk factor for failure to achieve MCID for NDI in the early (OR: 3.13 [1.10-8.87], p-value: .032) and late (OR: 5.01 [1.31-19.12], p-value: .018) postoperative periods, and VAS-Arm for the late postoperative period (OR: 36.63 [3.78-354.56], p-value: .002). Myelopathy was identified as a risk factor for failure to achieve MCID for VAS-Neck in the early postoperative period (OR: 3.40 [1.08-10.66], p-value: .036). Anxiety was identified as a risk factor for failure to achieve MCID for VAS-Neck in the late postoperative period (OR: 6.51 [1.91-22.18], p-value: .003). CDR at levels C5C7 was identified as a risk factor for failure to achieve MCID in NDI for the late postoperative period (OR: 9.74 [1.43-66.34], p-value: .020). CONCLUSIONS Our study identified several risk factors for failure to achieve MCID in common PROMs following CDR including predominant neck pain, myelopathy, anxiety, and CDR at levels C5-C7. These findings may help inform the approach to counseling patients on outcomes of CDR as the evidence suggests that those with the risk factors above may not improve as reliably after CDR.
Collapse
Affiliation(s)
- Eric Mai
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA; Weill Cornell Medical College, 1300 York Ave, New York, NY 10065, USA
| | - Pratyush Shahi
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Ryan Lee
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Daniel J Shinn
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA; Weill Cornell Medical College, 1300 York Ave, New York, NY 10065, USA
| | - Avani Vaishnav
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Kasra Araghi
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Nishtha Singh
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Omri Maayan
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA; Weill Cornell Medical College, 1300 York Ave, New York, NY 10065, USA
| | - Olivia C Tuma
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Anthony Pajak
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Tomoyuki Asada
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Maximilian K Korsun
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Sumedha Singh
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Yeo Eun Kim
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA; Weill Cornell Medical College, 1300 York Ave, New York, NY 10065, USA
| | - Philip K Louie
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Russel C Huang
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Todd J Albert
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - James Dowdell
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Evan D Sheha
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Sravisht Iyer
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA
| | - Sheeraz A Qureshi
- Department of Spine Surgery, Hospital for Special Surgery, 535 E 70th St, New York, NY, 10021 USA.
| |
Collapse
|
|
13
|
Yee TJ, Mummaneni PV. Biomechanics of Cervical Disk Replacement: Classifying Arthroplasty Implants. Clin Spine Surg 2023; 36:386-390. [PMID: 37735758 DOI: 10.1097/bsd.0000000000001523] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/26/2023] [Accepted: 08/10/2023] [Indexed: 09/23/2023]
Abstract
Cervical disk arthroplasty has been employed with increased frequency over the past 2 decades as a motion-preserving alternative to anterior cervical discectomy and fusion in select patients with myelopathy or radiculopathy secondary to degenerative disk disease. As indications continue to expand, an understanding of cervical kinematics and materials science is helpful for optimal implant selection. Cervical disk arthroplasty implants can be classified according to the mode of articulation and df , articulation material, and endplate construction. The incorporation of translational and rotational df allows the implant to emulate the dynamic and coupled centers of movement in the cervical spine. Durable and low-friction interfaces at the articulation sustain optimal performance and minimize particulate-induced tissue reactions. Endplate materials must facilitate osseous integration to ensure implant stability after primary fixation. These cardinal considerations underlie the design of the 9 implants currently approved by the FDA and serve as the foundation for further biomimetic research and development.
Collapse
Affiliation(s)
- Timothy J Yee
- Department of Neurosurgery, University of Michigan, Ann Arbor, MI
| | - Praveen V Mummaneni
- Department of Neurological Surgery, University of California-San Francisco, San Francisco, CA
| |
Collapse
|
|
14
|
Clohisy JCF, Maayan O, Asada T, Qureshi SA. Cervical Total Disc Replacement in Athletes: A Systematic Review. Clin Spine Surg 2023; 36:369-374. [PMID: 37735765 DOI: 10.1097/bsd.0000000000001526] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/10/2023] [Accepted: 08/10/2023] [Indexed: 09/23/2023]
Abstract
STUDY DESIGN Systematic review. OBJECTIVE To perform a systematic review to describe clinical characteristics, outcomes, and return to play after cervical total disc replacement (cTDR) in athletes. SUMMARY OF BACKGROUND DATA The role of cTDR in treating athletes with symptomatic cervical degenerative disc disease is undefined. METHODS A systematic search using MEDLINE through PubMed, EMBASE, and the Cochrane Library was conducted to identify all relevant literature. Data regarding study type, country in which the study was conducted, sample size, mean age, sex, type of sport, level of patient participation in sports, surgical indication, levels operated, type of implant, duration of follow-up, reoperations, surgical complications, extent of postoperative return to sports (RTSs), time to RTSs, and outcome notes were extracted from the included studies and analyzed. RESULTS Seven studies, including 4 case series and 3 case reports, and a total of 57 cTDR cases, were included. There was significant heterogeneity among the cTDR cases in terms of chosen sport and level of participation. Prestige LP was utilized in 51 out of 57 (89.5%) cases and 53 out of 57 (93%) cases were single-level. No reoperations were noted at a mean follow-up of 51.6 months. All patients returned to sports postoperatively. Return to training and competition occurred at a mean of 10.1 weeks and 30.7 weeks postoperatively, respectively. CONCLUSIONS The available evidence regarding cTDR in athletes indicates that these patients RTSs at high rates, with return to training occurring around 10 weeks and return to competition occurring around 30 weeks. Clinical outcomes in these patients are like those reported for the general population. Low-level evidence, small numbers of cases, heterogeneity in chosen sport and participation level, and predominance of a single implant type limit the conclusions that can be drawn from the current literature on this patient population.
Collapse
Affiliation(s)
- John C F Clohisy
- Department of Orthopedic Surgery, Hospital for Special Surgery, New York, NY
| | | | | | | |
Collapse
|
|
15
|
Divi SN, Plantz MA, Tegethoff J, Su BW. Current and Expanded Indications for Cervical Disc Arthroplasty: Beyond the FDA IDE Studies. Clin Spine Surg 2023; 36:375-385. [PMID: 37691166 DOI: 10.1097/bsd.0000000000001525] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/16/2023] [Accepted: 08/10/2023] [Indexed: 09/12/2023]
Abstract
The widespread success of cervical disc arthroplasty (CDA) has led to an interest in expanding indications beyond those outlined in the initial Food and Drug Administration investigational device exemption studies. Some of these off-label indications currently include 3-level and 4-level CDA, hybrid constructs with adjacent segment anterior cervical discectomy and fusion or corpectomy constructs, pre-existing kyphosis, revision of a failed anterior cervical discectomy and fusion to a CDA, CDA in the setting of significant degenerative disc disease and/or facet joint arthropathy, CDA for congenital cervical stenosis, and CDA in the presence of ossification of the posterior longitudinal ligament. This review article will summarize the current literature pertaining to the aforementioned indications.
Collapse
Affiliation(s)
- Srikanth N Divi
- Department of Orthopaedic Surgery, Northwestern University, Chicago IL
| | - Mark A Plantz
- Department of Orthopaedic Surgery, Northwestern University, Chicago IL
| | - Jason Tegethoff
- Department of Orthopaedic Surgery, Northwestern University, Chicago IL
| | - Brian W Su
- California Orthopedics & Spine, Novato, CA
| |
Collapse
|
|
16
|
Hartman TJ, Nie JW, MacGregor KR, Oyetayo OO, Zheng E, Singh K. Neck Disability Index as a Prognostic Factor for Outcomes Following Cervical Disc Replacement. Clin Spine Surg 2023; 36:310-316. [PMID: 37053118 DOI: 10.1097/bsd.0000000000001459] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/13/2022] [Accepted: 03/09/2023] [Indexed: 04/14/2023]
Abstract
STUDY DESIGN Retrospective review. OBJECTIVE We aim to elucidate the potential relationship between neck disability index (NDI) and outcomes following cervical disk replacement (CDR). SUMMARY OF BACKGROUND DATA The use of preoperative disability scores as predictors of outcomes following spine surgery has previously been studied, yet no literature has been published regarding its use in CDR. METHODS A retrospective database of a single orthopedic spine surgeon was searched for single-level CDR patients with preoperative NDI scores, excluding those with trauma, infection, or malignancy. Patients were separated into 2 cohorts by NDI score: Mild-Moderately Disabled (MD) (NDI<50) and Severely Disabled (NDI≥50). Patient-reported outcome measures were collected and compared within and between groups up to 1 year postoperatively and included Patient-reported Outcome Measurement Information System Physical Function, 12-Item Short Form (SF-12) Physical Component Score and Mental Component Score, visual analog scale (VAS) neck and arm pain, and NDI. MCID achievement rates were compared between the groups. RESULTS All PROM scores significantly improved for both cohorts at one or more postoperative time points compared with preoperative baseline ( P ≤0.049, all), with the exception of SF-12 Mental Component Score, which only significantly improved in the MD cohort at 2 postoperative points ( P ≤0.007, both). Between groups, the MD cohort reported significantly superior scores at one or more time points for all studied patient-reported outcome measures ( P ≤0.047, all). MCID achievement rate did not significantly vary for any outcome at any time between cohorts. CONCLUSION Regardless of preoperative disability, both groups reported improvement in physical function, pain, and disability scores following CDR. While not finding significance, patients with severe disability preoperatively consistently demonstrated higher minimal clinically important difference achievement in NDI. These data do not promote the use of NDI as a prognostic factor for outcomes following CDR. Further study with larger patient populations may be useful to clarify this potential relationship.
Collapse
Affiliation(s)
- Timothy J Hartman
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL
| | | | | | | | | | | |
Collapse
|
|
17
|
Hartman TJ, Nie JW, Zheng E, Oyetayo OO, MacGregor KR, Singh K. The Influence of Workers' Compensation Status on Patient-Reported Outcomes after Cervical Disc Arthroplasty at an Ambulatory Surgical Center. J Am Acad Orthop Surg 2023; 31:e657-e664. [PMID: 37054388 DOI: 10.5435/jaaos-d-22-00892] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/08/2022] [Accepted: 03/12/2023] [Indexed: 04/15/2023] Open
Abstract
INTRODUCTION Workers' compensation (WC) status tends to negatively affect patient outcomes in spine surgery. This study aims to evaluate the potential effect of WC status on patient-reported outcomes (PROs) after cervical disc arthroplasty (CDR) at an ambulatory surgical center (ASC). METHODS A single-surgeon registry was retrospectively reviewed for patients who had undergone elective CDR at an ASC. Patients with missing insurance data were excluded. Propensity score-matched cohorts were generated by the presence or lack of WC status. PROs were collected preoperatively and at 6-week, 12-week, 6-month, and 1-year time points. PROs included the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), visual analog scale (VAS) neck and arm pain, and Neck Disability Index. PROs were compared within and between groups. Minimum clinically important difference (MCID) achievement rates were compared between groups. RESULTS Sixty-three patients were included, with 36 without WC (non-WC) and 27 with WC. The non-WC cohort demonstrated postoperative improvement in all PROs at all time points, with the exception of VAS arm past the 12-week point ( P ≤ 0.030, all). The WC cohort demonstrated postoperative improvement in VAS neck at 12-week, 6-month, and 1-year time points ( P ≤ 0.025, all). The WC cohort improved in VAS arm and Neck Disability Index at the 12-week and 1-year points as well ( P ≤ 0.029, all). The non-WC cohort reported superior PRO scores in every PRO at one or more postoperative time points ( P ≤ 0.046, all). The non-WC cohort demonstrated higher rates of minimum clinically important difference achievement in PROMIS-PF at 12 weeks ( P ≤ 0.024). CONCLUSION Patients with WC status undergoing CDR at an ASC may report inferior pain, function, and disability outcomes compared with those with private or government-provided insurance. Perceived inferior disability in WC patients persisted into the long-term follow-up period (1 year). These findings may aid surgeons in setting realistic preoperative expectations with patients at risk of inferior outcomes.
Collapse
Affiliation(s)
- Timothy J Hartman
- From the Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL
| | | | | | | | | | | |
Collapse
|
|
18
|
Karabacak M, Margetis K. Machine Learning-Based Prediction of Short-Term Adverse Postoperative Outcomes in Cervical Disc Arthroplasty Patients. World Neurosurg 2023; 177:e226-e238. [PMID: 37330003 DOI: 10.1016/j.wneu.2023.06.025] [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: 03/10/2023] [Revised: 06/08/2023] [Accepted: 06/09/2023] [Indexed: 06/19/2023]
Abstract
OBJECTIVE This study aimed to assess the effectiveness of machine learning (ML) algorithms in predicting short-term adverse postoperative outcomes after cervical disc arthroplasty (CDA) and to create a user-friendly and accessible tool for this purpose. METHODS The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database was used to identify patients who underwent CDA. The outcome of interest was the combined occurrence of adverse events in the short-term postoperative period, including prolonged stay, major complications, nonhome discharges, and 30-day readmissions. To predict the combined outcome of interest, short-term adverse postoperative outcomes, 4 different ML algorithms were utilized to develop predictive models, and these models were incorporated into an open access web application. RESULTS A total of 6,604 patients that underwent CDA were included in the analysis. The mean area under the receiver operating characteristic curve (AUROC) and accuracy were 0.814 and 87.8% for all algorithms. SHapley Additive exPlanations (SHAP) analyses revealed that white race was the most important predictor variable for all 4 algorithms. The following URL will take users to the open access web application created to provide predictions for individual patients based on their characteristics: huggingface.co/spaces/MSHS-Neurosurgery-Research/NSQIP-CDA. CONCLUSIONS ML approaches have the potential to predict postoperative outcomes after CDA surgery. As the amount of data in spinal surgery grows, the development of predictive models as clinically useful decision-making tools may significantly improve risk assessment and prognosis. We present and make publicly available predictive models for CDA intended to achieve the goals mentioned above.
Collapse
Affiliation(s)
- Mert Karabacak
- Department of Neurosurgery, Mount Sinai Health System, New York, New York, USA
| | | |
Collapse
|
|
19
|
Sheng XQ, Wu TK, Liu H, Meng Y. Incidence of Heterotopic Ossification at 10 years After Cervical Disk Replacement: A Systematic Review and Meta-analysis. Spine (Phila Pa 1976) 2023; 48:E203-E215. [PMID: 37036304 PMCID: PMC10249612 DOI: 10.1097/brs.0000000000004674] [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: 08/29/2022] [Accepted: 02/09/2023] [Indexed: 04/11/2023]
Abstract
STUDY DESIGN Systematic review and meta-analysis. OBJECTIVE This study aimed to assess the incidence of heterotopic ossification (HO) 10 years after cervical disk replacement (CDR). SUMMARY OF BACKGROUND DATA HO is a common complication after CDR and may limit the range of motion of the artificial disk. As HO usually progresses slowly, a long-term follow-up is required to better understand its incidence. In recent years, the increasing number of original articles reporting 10-year outcomes gives us the opportunity to better understand the long-term incidence of HO. MATERIALS AND METHODS We searched PubMed, Medline, Embase, and Cochrane Library databases to identify eligible studies. The incidence of HO was pooled, and subgroup analysis was performed. Meta-regression analyses were conducted to identify factors contributing to heterogeneity. RESULTS Eleven studies with at least 10 years of follow-up comprising 1140 patients who underwent CDR were included. The pooled incidence of overall HO was 70% (95% CI, 60%-81%) at 10 years postoperatively, 60% (95% CI, 44%-75%) at five or six years postoperatively, and 50% (95% CI, 27%-72%) at one or two years postoperatively. The pooled incidence of severe HO (grade 3 or 4) was 37% (95% CI, 29%-45%), and mild HO (grade 1 to 2) was 30% (95% CI, 17%-44%) at 10 years of follow-up. Pooled range of motion decreased from 8.59° before surgery to 7.40° 10 years after surgery. Subgroup analysis showed that HO incidence differed according to the prosthesis type. The earlier publication was associated with a higher pooled incidence of severe HO in the meta-regression analysis. CONCLUSIONS This is the first meta-analysis providing detailed information on the pooled 10-year incidence of HO after CDR. The incidence of HO seems to increase with the length of follow-up. LEVEL OF EVIDENCE 3.
Collapse
|
|
20
|
Hartman TJ, Nie JW, Federico VP, MacGregor KR, Oyetayo OO, Zheng E, Massel DH, Sayari AJ, Singh K. Does Symptom Duration Prior to Anterior Cervical Discectomy and Fusion for Disc Herniation Influence Patient-Reported Outcomes in a Workers' Compensation Population? World Neurosurg 2023; 173:e748-e754. [PMID: 36898631 DOI: 10.1016/j.wneu.2023.03.008] [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: 01/27/2023] [Revised: 02/28/2023] [Accepted: 03/02/2023] [Indexed: 03/11/2023]
Abstract
OBJECTIVE To evaluate the influence of symptom duration before anterior cervical discectomy and fusion (ACDF) on patient-reported outcomes (PROs) in workers' compensation patients. METHODS A prospective registry was searched for workers' compensation patients who underwent ACDF for herniated disc. Two cohorts based on symptom duration were formed: lesser duration (LD) (<6 months) and prolonged duration (PD) (≥6 months). PROs were collected preoperatively and at 6 weeks, 12 weeks, 6 months, and 1 year postoperatively. PROs were compared within and between groups. Rates of minimum clinically important difference (MCID) were compared between groups. RESULTS The study included 63 patients. The LD cohort reported improvement in Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF), Neck Disability Index (NDI), and visual analog scale (VAS) neck at 12 weeks and 6 months and VAS arm at all periods (all P ≤ 0.036). The LD cohort reported improvement in NDI at 12 weeks and 6 months and VAS arm at 6 weeks, 12 weeks, and 6 months (all P ≤ 0.037). Between groups, the LD cohort demonstrated superior scores in PROMIS-PF at 6 weeks, 12 weeks, and 6 months; NDI preoperatively and at 6 weeks, 12 weeks, and 6 months; VAS neck at 12 weeks; and 9-item Patient Health Questionnaire (PHQ-9) at 6 months (all P ≤ 0.045). The LD group was more likely to achieve MCID in PROMIS-PF at 12 weeks (P = 0.012). The PD group was more likely to achieve MCID in PHQ-9 at 6 months (P = 0.023). CONCLUSIONS Regardless of length of symptom duration before ACDF in workers' compensation patients, the patients demonstrated improvements in disability and arm pain. Patients with LD also demonstrated improvements in physical function and neck pain. Patients with LD demonstrated superior scores in physical function, pain, disability, and mental health and were more likely to achieve clinically significant improvement in physical function. Patients with PD were more likely to achieve clinically significant improvement in mental health.
Collapse
Affiliation(s)
- Timothy J Hartman
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - James W Nie
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - Vincent P Federico
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - Keith R MacGregor
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - Omolabake O Oyetayo
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - Eileen Zheng
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - Dustin H Massel
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - Arash J Sayari
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA
| | - Kern Singh
- Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.
| |
Collapse
|
|
21
|
Clohisy JCF, Abjornson C, Bauer TW, Baral E, Albert TJ. Delayed Failure of M6-C Cervical Disc Arthroplasty After Conversion of Adjacent Cervical Disc Arthroplasty to Fusion: A Case Report. JBJS Case Connect 2023; 13:01709767-202306000-00013. [PMID: 37071739 DOI: 10.2106/jbjs.cc.22.00788] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/20/2023]
Abstract
CASE We present a delayed failure of an M6-C cervical disc arthroplasty after conversion of a subjacent failed cervical disc arthroplasty to fusion. The annular component had failed, and the core had been ejected. Histology demonstrated a giant cell reaction to polyethylene debris, and tissue cultures were positive for Cutibacterium acnes. CONCLUSION This is the first report of M6-C failure after conversion of an adjacent arthroplasty to fusion. A growing number of reports surrounding the M6-C failure rate and mechanisms raise concern about the device's durability and underscore the importance of routine clinical and radiographic surveillance for these patients.
Collapse
Affiliation(s)
- John C F Clohisy
- Department of Orthopaedics, Hospital for Special Surgery, New York, New York
| | - Celeste Abjornson
- Integrated Spine Research Program, Hospital for Special Surgery, New York, New York
| | - Thomas W Bauer
- Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, New York, New York
| | - Elexis Baral
- Department of Biomechanics, Hospital for Special Surgery, New York, New York
| | - Todd J Albert
- Department of Orthopaedics, Hospital for Special Surgery, New York, New York
| |
Collapse
|
|
22
|
Peolsson A, Löfgren H, Dedering Å, Kristedal M, Öberg B, Zsigmond P, Wibault J. Neurological outcomes after surgery and postoperative rehabilitation for cervical radiculopathy due to disc disease: a 2-year-follow-up of a randomized clinical trial. Sci Rep 2023; 13:3830. [PMID: 36882483 PMCID: PMC9992477 DOI: 10.1038/s41598-023-31005-z] [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: 10/11/2022] [Accepted: 03/06/2023] [Indexed: 03/09/2023] Open
Abstract
Reports on neurological outcomes in patients with cervical radiculopathy (CR) undergoing surgery and postoperative rehabilitation are important to inform prognosis. This 2-year-follow-up of a randomized clinical trial aimed to compare secondary neurological outcomes between structured postoperative rehabilitation and a standard approach after surgery for CR. A secondary aim was to increase knowledge about recovery of neurological impairments in relation to patient-reported neck disability. Neurological outcomes included assessment of sensibility, motor function, arm reflexes and the Spurling test. A total of 153 and 135 participants (> 70% response rate) completed the clinical examination. Between-group differences, changes over time, and associations between persistent neurological impairments and the Neck Disability Index were investigated. No between-group differences were reported (p > 0.07), and neurological impairments in sensibility, motor function, and a positive Spurling test decreased over time in both groups (p < 0.04). Persistent impairments in sensibility and reflex arm were most frequent at follow-up, whereas, a persistent positive Spurling test, and impairments in motor function were associated with higher NDI score. Neurological outcomes improved over time in patients undergoing surgery for CR with no between-group differences., However, persistent neurological impairments were common, and associated with poorer outcome for patient-reported neck disability.Clinical registration: clinicaltrial.gov NCT01547611, 08/03/2012, Title: Outcome of physiotherapy after surgery for cervical disc disease: a prospective multi-centre trial.
Collapse
Affiliation(s)
- Anneli Peolsson
- Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.,Department of Health, Medicine and Caring Sciences, Unit of Clinical Medicine, Occupational and Environmental Medicine Center, Linköping University, Linköping, Sweden
| | - Håkan Löfgren
- Neuro-Orthopedic Center, Jönköping, Region Jönköping County, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
| | - Åsa Dedering
- Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
| | - Mattias Kristedal
- Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.,Department of Activity and Health, and Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
| | - Birgitta Öberg
- Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden
| | - Peter Zsigmond
- Department of Neurosurgery, Linköping University Hospital, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
| | - Johanna Wibault
- Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden. .,Department of Activity and Health, and Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
| |
Collapse
|
|
23
|
Evaluation of Topology Optimization Using 3D Printing for Bioresorbable Fusion Cages: A Biomechanical Study in a Porcine Model. Spine (Phila Pa 1976) 2023; 48:E46-E53. [PMID: 36130044 PMCID: PMC9855756 DOI: 10.1097/brs.0000000000004491] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2022] [Accepted: 08/31/2022] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Preclinical biomechanical study of topology optimization versus standard ring design for bioresorbable poly-ε-caprolactone (PCL) cervical spine fusion cages delivering bone morphogenetic protein-2 (BMP-2) using a porcine model. OBJECTIVE The aim was to evaluate range of motion (ROM) and bone fusion, as a function of topology optimization and BMP-2 delivery method. SUMMARY OF BACKGROUND DATA 3D printing technology enables fabrication of topology-optimized cages using bioresorbable materials, offering several advantages including customization, and lower stiffness. Delivery of BMP-2 using topology optimization may enhance the quality of fusion. METHODS Twenty-two 6-month-old pigs underwent anterior cervical discectomy fusion at one level using 3D printed PCL cages. Experimental groups (N=6 each) included: Group 1: ring design with surface adsorbed BMP-2, Group 2: topology-optimized rectangular design with surface adsorbed BMP-2, and Group 3: ring design with BMP-2 delivery via collagen sponge. Additional specimens, two of each design, were implanted without BMP-2, as controls. Complete cervical segments were harvested six months postoperatively. Nanocomputed tomography was performed to assess complete bony bridging. Pure moment biomechanical testing was conducted in all three planes, separately. Continuous 3D motions were recorded and analyzed. RESULTS Three subjects suffered early surgical complications and were not evaluated. Overall, ROM for experimental specimens, regardless of design or BMP-2 delivery method, was comparable, with no clinically significant differences among groups. Among experimental specimens at the level of the fusion, ROM was <1.0° in flexion and extension, indicative of fusion, based on clinically applied criteria for fusion of <2 to 4°. Despite the measured biomechanical stability, using computed tomography evaluation, complete bony bridging was observed in 40% of the specimens in Group 1, 50% of Group 2, 100% of Group 3, and none of the control specimens. CONCLUSION A topology-optimized PCL cage with BMP-2 is capable of resulting in an intervertebral fusion, similar to a conventional ring-based design of the same bioresorbable material.
Collapse
|
|
24
|
Toci GR, Lambrechts MJ, Karamian BA, Canseco JA, Hilibrand AS, Kepler CK, Vaccaro AR, Schroeder GD. Patients with radiculopathy have worse baseline disability and greater improvements following anterior cervical discectomy and fusion compared to patients with myelopathy. Spine J 2023; 23:238-246. [PMID: 36257530 DOI: 10.1016/j.spinee.2022.10.005] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/13/2022] [Revised: 09/21/2022] [Accepted: 10/06/2022] [Indexed: 11/09/2022]
Abstract
BACKGROUND CONTEXT Anterior cervical discectomy and fusion (ACDF) is commonly performed in patients with radiculopathy and myelopathy. Although the goal of surgery in patients with radiculopathy is to improve function and reduce pain, patients with myelopathy undergo surgery to halt disease progression. Although the expectations between these preoperative diagnoses are generally understood to be disparate by spine surgeons, there is limited literature demonstrating their discordant outcomes. PURPOSE To compare improvements in patient reported outcome measures (PROMs) for patients undergoing ACDF for myelopathy or radiculopathy. Secondarily, we analyzed the proportion of patients who attain the minimum clinically important difference (MCID) postoperatively using thresholds derived from radiculopathy, myelopathy, and mixed cohort studies. STUDY DESIGN/SETTING Single institution retrospective cohort study PATIENT SAMPLE: Patients undergoing primary, elective ACDF with a preoperative diagnosis of radiculopathy or myelopathy and a complete set of preoperative and one-year postoperative PROMs. OUTCOME MEASURES Outcome measures included the following PROMs: Short-Form 12 Physical Component (PCS-12) and Mental Component (MCS-12) scores, the Visual Analog Scale (VAS) Arm score, and the Neck Disability Index (NDI). Hospital readmissions and revision surgery were also collected and evaluated. METHODS Patients undergoing an ACDF from 2014 to 2020 were identified and grouped based on preoperative diagnosis (radiculopathy or myelopathy). We utilized "general MCID" thresholds from a cohort of patients with degenerative spine conditions, and "specific MCID" thresholds generated from cohorts of patients with myelopathy or radiculopathy, respectively. Multivariate linear regressions were performed for delta (∆) PROMs and multivariate logistic regressions were performed for both general and specific MCID improvements. RESULTS A total of 798 patients met inclusion criteria. Patients with myelopathy had better baseline function and arm pain (MCS-12: 49.6 vs 47.6, p=.018; VAS Arm: 3.94 vs 6.02, p<.001; and NDI: 34.1 vs 41.9, p<.001), were older (p<.001), had more comorbidities (p=.014), more levels fused (p<.001), and had decreased improvement in PROMs following surgery compared to patients with radiculopathy (∆PCS-12: 4.76 vs 7.21, p=.006; ∆VAS Arm: -1.69 vs -3.70, p<.001; and ∆NDI: -11.94 vs -18.61, p<.001). On multivariate analysis, radiculopathy was an independent predictor of increased improvement in PCS-12 (β=2.10, p=.019), ∆NDI (β=-5.36, p<.001), and ∆VAS Arm (β=-1.93, p<.001). Radiculopathy patients were more likely to achieve general MCID improvements following surgery (NDI: Odds ratio (OR): 1.42, p=.035 and VAS Arm: OR: 2.98, p<.001), but there was no difference between patients with radiculopathy or myelopathy when using radiculopathy and myelopathy specific MCID thresholds (MCS-12: p=.113, PCS-12: p=.675, NDI: p=.108, and VAS Arm: p=.314). CONCLUSIONS Patients undergoing ACDF with myelopathy or radiculopathy represent two distinct patient populations with differing treatment indications and clinical outcomes. Compared to radiculopathy, patients with myelopathy have better baseline function, decreased improvement in PROMs, and are less likely to reach MCID using general threshold values, but there is no difference in the proportion reaching MCID when using specific threshold values. LEVEL OF EVIDENCE IRB.
Collapse
Affiliation(s)
- Gregory R Toci
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA
| | - Mark J Lambrechts
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA.
| | - Brian A Karamian
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA
| | - Jose A Canseco
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA
| | - Alan S Hilibrand
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA
| | - Christopher K Kepler
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA
| | - Alexander R Vaccaro
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA
| | - Gregory D Schroeder
- Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA 19107, USA
| |
Collapse
|
|
25
|
Watts CR, Haapala JL. Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion: Comparison of 30-Day Population Comorbidities and Perioperative Complications Using 6 Years of American College of Surgeons National Surgical Quality Improvement Program Participant Use File Data. World Neurosurg 2023; 170:e79-e114. [PMID: 36283651 DOI: 10.1016/j.wneu.2022.10.072] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2022] [Revised: 10/18/2022] [Accepted: 10/19/2022] [Indexed: 11/13/2022]
Abstract
OBJECTIVE American College of Surgeons National Surgical Quality Improvement Program Participant Use File data from 2014 through 2019 were used to compare 1- and 2-level anterior cervical discectomy and fusion (ACDF) and cervical total disc replacement (cTDR) with respect to: patient demographics, comorbidities, adverse events, and 30-day morbidity rates. METHODS One- and 2-level ACDF and cTDR patients were identified by current procedural terminology codes. Demographics, comorbidities, and adverse events were summarized. Unmatched cohorts were compared using Wilcoxon Rank Sum test for continuous variables, Pearson χ2 test for categorical variables, and 30-day morbidity using inverse probability of treatment weighted log-binomial regression. RESULTS American College of Surgeons National Surgical Quality Improvement Program 2014 through 2019 Participant Use File datasets represent 4,862,497 unique patients, identifying 13,347 1-level, 6933 2-level ACDF, 3114 1-level, and 862 2-level cTDR patient cohorts. Statistically significant differences between cohorts are extensive: age, sex, race, admission status, patient origin, discharge disposition, emergent surgery, surgical specialty, American Society of Anesthesiologists classification, wound class, operative time, hospital LOS, BMI, functional status, smoking, diabetes, dyspnea, chronic obstructive pulmonary disease, congestive heart failure, hypertension, renal failure, dialysis, cancer, steroid use, anemia, bleeding disorders, systemic sepsis, and number of concurrent comorbid conditions. Inverse probability of treatment weighted log-binomial models, demonstrated increased risk of deep venous thrombosis/thrombophlebitis, pulmonary embolism, deep incisional surgical site infection, pneumonia, and unplanned return to operating room associated with ACDF while increased risk of cerebral vascular accident/stroke with neurological deficit and myocardial infarction associated with cTDR. The composite complications outcome favors cTDR over ACDF for 30-day morbidity. No mortalities occurred within the cTDR cohort. CONCLUSIONS Adjusting for demographics and comorbidities; ACDF has a higher average risk of adverse event. When ACDF and cTDR are equipoise, consideration for cTDR may be indicated in populations with higher rates of comorbid conditions.
Collapse
Affiliation(s)
- Charles R Watts
- Department of Neurosurgery, Park Nicollet, Methodist Hospital, St. Louis Park, Minnesota, USA; Health Partners Institute, Bloomington, Minnesota, USA.
| | | |
Collapse
|
|
26
|
Muacevic A, Adler JR, Bishi H, Raja H, Ravi K, Dannawi Z. A Retrospective Comparative Study of Long-Term Outcomes Following Cervical Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion. Cureus 2022; 14:e32399. [PMID: 36636537 PMCID: PMC9831620 DOI: 10.7759/cureus.32399] [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: 12/11/2022] [Indexed: 12/14/2022] Open
Abstract
Introduction The traditional treatment for patients with radiculopathy and myelopathy caused by degenerative disc disease was anterior cervical discectomy and fusion (ACDF). However, a documented complication of ACDF is adjacent segment degeneration (ASD). An alternative that was developed was total disc replacement (TDR). The aim of this study was to determine and compare the short- and medium-to-long-term outcomes after a TDR or ACDF. Methods A retrospective review of 154 patients who had single and two-level ACDFs and 90 TDRs performed by a single surgeon between 2011 and 2017 was conducted. Parameters for comparisons include both radiological evaluation and patient-reported outcome measures (PROMS) at six weeks, one year, and two years postoperatively. The Neck Disability Index (NDI) and the visual analogue scale (VAS) for neck and arm pain are used to evaluate pain, function, patient satisfaction, and overall clinical success. Results TDR and ACDF showed significant improvement in NDI and VAS when compared to pre- and post-operatively at both six weeks (p<0.05 & P=0.032, respectively) and two years (p<0.05 & 0=0.026, respectively). TDR vs. ACDF showed no significant difference (p<0.05). VAS scores after ACDF showed improvement from 13.41 to 3.94 at two years (p<0.001). TDR showed similar scores of 12.5 to 3.55 (p<0.001). The radiological fusion rate at 12 or 24 months showed no significant difference between the two groups. There were two cases that required re-operation after ACDF (1.2%), and two that required TDR (2.2%). Conclusion Both TDR and ACDF lead to clinically significant improvements in pain and function scores. We did not find a statistically significant difference in NDI and VAS in the neck and arm. The results are in agreement with others' assessments of these two treatment modalities. Our conclusions supplement the literature about these operative options for degenerative disc disease of the cervical spine and are a useful addition to the armamentarium in the assessment of patients with degenerative pathology of the c-spine.
Collapse
|
|
27
|
Kölle L, Ignasiak D, Ferguson SJ, Helgason B. Ceramics in total disc replacements: A scoping review. Clin Biomech (Bristol, Avon) 2022; 100:105796. [PMID: 36435073 DOI: 10.1016/j.clinbiomech.2022.105796] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/01/2022] [Revised: 10/04/2022] [Accepted: 10/07/2022] [Indexed: 02/07/2023]
Abstract
BACKGROUND Ceramics are used in Total Disc Replacements (1) in articulating surfaces for their wear resistance and biocompatibility and (2) on endplates to promote osseointegration. They furthermore exhibit MRI and CT compatibility. These properties address main challenges associated with non-ceramic Total Disc Replacements i.e. wear, migration and postoperative imaging. While brittleness of ceramics caused fear of fracture in the past, improvements of ceramic materials were made and considerable clinical experience with ceramic Total Disc Replacements was gained. This review aims to assess the evidence on the use of ceramics in Total Disc Replacements and compare safety and effectiveness of ceramic Total Disc Replacements to spinal fusion and Total Disc Replacements in general. METHODS We conducted a scoping review on the use of ceramics in Total Disc Replacements using Scopus, Web of Science and PubMed. The review includes 36 clinical, ex vivo and nonhuman in vivo, tribological and mechanical studies and case reports. FINDINGS Ceramics are used in cervical Total Disc Replacements, with safety and efficacy confirmed in clinical studies, with up to 10 and 3.3 years follow-up, for articulation and osseointegration applications, respectively. Clinical evidence shows that ceramic Total Disc Replacements (alike non-ceramic ones) restore segmental motion and result in non-inferior and possibly superior outcomes to spinal fusion. In vivo studies show osseointegration comparable to non-ceramic devices. Tribological studies suggest appropriate wear properties. INTERPRETATION We found no indications of systematic problems with the use of ceramics in Total Disc Replacements. Ceramics are suitable materials for Total Disc Replacements.
Collapse
Affiliation(s)
- Lucia Kölle
- Institute for Biomechanics, ETH Zürich, Hönggerbergring 64, 8093 Zürich, Switzerland.
| | - Dominika Ignasiak
- Institute for Biomechanics, ETH Zürich, Hönggerbergring 64, 8093 Zürich, Switzerland
| | - Stephen J Ferguson
- Institute for Biomechanics, ETH Zürich, Hönggerbergring 64, 8093 Zürich, Switzerland
| | - Benedikt Helgason
- Institute for Biomechanics, ETH Zürich, Hönggerbergring 64, 8093 Zürich, Switzerland
| |
Collapse
|
|
28
|
Hartman TJ, Nie JW, Pawlowski H, Prabhu MC, Vanjani NN, Singh K. Impact of age within younger populations on outcomes following cervical surgery in the ambulatory setting. J Clin Orthop Trauma 2022; 34:102016. [PMID: 36164388 PMCID: PMC9508464 DOI: 10.1016/j.jcot.2022.102016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/26/2022] [Revised: 08/30/2022] [Accepted: 09/07/2022] [Indexed: 11/27/2022] Open
Abstract
Objective To determine the effect of age within the younger population seen at ambulatory surgical centers on patient-reported outcome measures (PROMs) after cervical spine surgery. Methods Patients of age <65 years undergoing single-level anterior cervical discectomy and fusion (ACDF) or cervical disc replacement (CDR) were included. Patients were divided by mean age of initial population (46 years). PROMs included Patient-reported Outcome Measurement Information System Physical Function (PROMIS-PF), 12-Item Short-Form Physical Component Survey (SF-12 PCS), Visual Analog Scale (VAS) neck, VAS arm, Neck Disability Index (NDI) collected preoperatively and at postoperative time points up to 2 years. Results 138 patients were included, with 66 patients <46 years. Both cohorts demonstrated improvement from preoperative baseline with regard to all studied PROMs at multiple time points postoperatively (p ≤ 0.042, all). Between groups, the older cohort demonstrated greater mean PROMIS-PF scores preoperatively and at 6 weeks (p ≤ 0.011, both), while VAS arm scores were lower in the older group at 1 year (p = 0.002), and NDI scores were lower in the older group at 6 weeks and 1 year (p < 0.027, both). Minimal Clinically Important Difference (MCID) achievement rates were greater in the younger group in PROMIS PF at 2 years (p = 0.002), and in the older group in VAS arm score at 1 year (p = 0.007). Conclusion Both cohorts showed significant improvement at multiple postoperative time points for all PROMs. Between groups, the older group reported more favorable physical function, VAS arm, and NDI scores at several time points. However, MCID achievement rates only significantly differed in two PROMs at singular time points. Difference in age in patients <65 years likely does not significantly affect long-term outcomes after cervical spine surgery.
Collapse
Affiliation(s)
- Timothy J. Hartman
- Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St. Suite #300, Chicago, IL, 60612, USA
| | - James W. Nie
- Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St. Suite #300, Chicago, IL, 60612, USA
| | - Hanna Pawlowski
- Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St. Suite #300, Chicago, IL, 60612, USA
| | - Michael C. Prabhu
- Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St. Suite #300, Chicago, IL, 60612, USA
| | - Nisheka N. Vanjani
- Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St. Suite #300, Chicago, IL, 60612, USA
| | - Kern Singh
- Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St. Suite #300, Chicago, IL, 60612, USA
| |
Collapse
|
|
29
|
Wang X, Lin Y, Wang Q, Gao L, Feng F. A Bibliometric Analysis of the Top 100 Cited Articles in Anterior Cervical Discectomy and Fusion. J Pain Res 2022; 15:3137-3156. [PMID: 36311292 PMCID: PMC9604433 DOI: 10.2147/jpr.s375720] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2022] [Accepted: 09/23/2022] [Indexed: 11/23/2022] Open
Abstract
Study design A bibliometric analysis. Objective To identify and analyze the top 100 cited articles in anterior cervical discectomy and fusion. Summary of Background Data Anterior cervical discectomy and fusion (ACDF) is one of the most routine surgical procedures in spine surgery. Many surgeons and academics have researched ACDF thoroughly and published numerous articles. However, there is no relevant bibliometric analysis. Therefore, our study aims to identify and analyze the top 100 cited articles in ACDF to identify the research trends. Methods We searched the Web of Science (WOS) Core Collection database with restrictions and identified the top 100 cited publications in ACDF for analysis. Results The citation counts of the top 100 cited publications ranged from 37 to 361 (mean 67.42). All studies were published between 2008 and 2019, with 2013 and 2015 the most prolific years. The journals Spine and Journal of Neurosurgery-Spine provided the majority of the articles. Overall, the 100 articles came from 12 countries, with the United States being the top producer, followed by China and South Korea. The most frequent keywords were "spine", "anterior cervical discectomy and fusion", "interbody fusion", 'arthrodesis', "follow-up", "decompression", and "ACDF". Conclusion ACDF has been regarded as a classical gold standard in anterior cervical surgery, and the emergence of new surgical procedures has not affected its status. Cervical disc arthroplasty still needs further research and development. As the first bibliometric analysis of ACDF, this bibliometric study is meant to provide guidance for clinicians and scholars to research the development trend of this field.
Collapse
Affiliation(s)
- Xun Wang
- Zhejiang Chinese Medical University, Hangzhou, Zhejiang310053, People’s Republic of China
| | - Yanze Lin
- Zhejiang Chinese Medical University, Hangzhou, Zhejiang310053, People’s Republic of China
| | - Qiongtai Wang
- Zhejiang Chinese Medical University, Hangzhou, Zhejiang310053, People’s Republic of China
| | - Liqing Gao
- Zhejiang Chinese Medical University, Hangzhou, Zhejiang310053, People’s Republic of China
| | - Fabo Feng
- Center for Plastic & Reconstructive Surgery, Department of Orthopedics, Zhejiang Provincial People’s Hospital (Affiliated People’s Hospital, Hangzhou Medical College), Hangzhou, Zhejiang, 310014, People’s Republic of China,Correspondence: Fabo Feng, Center for Plastic & Reconstructive Surgery, Department of Orthopedics, Zhejiang Provincial People’s Hospital (Affiliated People’s Hospital, Hangzhou Medical College), Hangzhou, Zhejiang, 310014, People’s Republic of China, Email
| |
Collapse
|
|
30
|
Colman MW, Zavras AG, Federico VP, Nolte MT, Butler AJ, Singh K, Phillips FM. Longitudinal assessment of segmental motion of the cervical spine following total disc arthroplasty: a comparative analysis of devices. J Neurosurg Spine 2022; 37:556-562. [PMID: 35426820 DOI: 10.3171/2022.2.spine22143] [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: 01/31/2022] [Accepted: 02/28/2022] [Indexed: 11/06/2022]
Abstract
OBJECTIVE Total disc arthroplasty (TDA) has been shown to be an effective and safe treatment for cervical degenerative disc disease at short- and midterm follow-up. However, there remains a paucity of literature reporting the differences between individual prosthesis designs with regard to device performance. In this study, the authors evaluated the long-term maintenance of segmental range of motion (ROM) at the operative cervical level across a diverse range of TDA devices. METHODS In this study, the authors retrospectively evaluated all consecutive patients who underwent 1- or 2-level cervical TDA between 2005 and 2020 at a single institution. Patients with a minimum of 6 months of follow-up and lateral flexion/extension radiographs preoperatively, 2 months postoperatively, and at final follow-up were included. Radiographic measurements included static segmental lordosis, segmental range of motion (ROM) on flexion/extension, global cervical (C2-7) ROM on flexion/extension, and disc space height. The paired t-test was used to evaluate improvement in radiographic parameters. Subanalysis between devices was performed using one-way ANCOVA. Significance was determined at p < 0.05. RESULTS A total of 85 patients (100 discs) were included, with a mean patient age of 46.01 ± 8.82 years and follow-up of 43.56 ± 39.36 months. Implantations included 22 (22.00%) M6-C, 51 (51.00%) Mobi-C, 14 (14.00%) PCM, and 13 (13.00%) ProDisc-C devices. There were no differences in baseline radiographic parameters between groups. At 2 months postoperatively, PCM provided significantly less segmental lordosis (p = 0.037) and segmental ROM (p = 0.039). At final follow-up, segmental ROM with both the PCM and ProDisc-C devices was significantly less than that with the M6-C and Mobi-C devices (p = 0.015). From preoperatively to 2 months postoperatively, PCM implantation led to a significant loss of lordosis (p < 0.001) and segmental ROM (p = 0.005) relative to the other devices. Moreover, a significantly greater decline in segmental ROM from 2 months postoperatively to final follow-up was seen with ProDisc-C, while segmental ROM increased significantly over time with Mobi-C (p = 0.049). CONCLUSIONS Analysis by TDA device brand demonstrated that motion preservation differs depending on disc design. Certain devices, including M6-C and Mobi-C, improve ROM on flexion/extension from preoperatively to postoperatively and continue to increase slightly at final follow-up. On the other hand, devices such as PCM and ProDisc-C contributed to greater segmental stiffness, with a gradual decline in ROM seen with ProDisc-C. Further studies are needed to understand how much segmental ROM is ideal after TDA for preservation of physiological cervical kinematics.
Collapse
|
|
31
|
Ding Z, Ren Y, Cao H, Li J. Top 100 most cited articles on anterior cervical discectomy and fusion. Front Surg 2022; 9:1000360. [PMID: 36147696 PMCID: PMC9485582 DOI: 10.3389/fsurg.2022.1000360] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2022] [Accepted: 08/18/2022] [Indexed: 11/25/2022] Open
Abstract
Study Design Bibliometric analysis. Objective Anterior cervical discectomy and fusion (ACDF) is a typical surgical method in spine surgery and has progressed significantly in the last several decades. The purpose of this study is to determine how the 100 most-cited original articles on ACDF have been the most influential in this field by identifying and analyzing them. Methods The articles on ACDF were identified by searching the Thomson ISI Web of Science database on 30 May 2022. The 100 most-cited articles were selected according to specific criteria. The data extracted from the articles included title, publication date, total citations, journal name, first author, institutions, and keywords. Results The total number of citations was 13,181, with a mean number of 131.81 ± 100.18. The publication dates ranged from 1994 to 2018. Most of these articles originated in the United States (68%) and were published in the 2000s (32%) and 2010s (48%). Spine published most of the articles (30%), followed by the Journal of Neurosurgery-Spine (16%), Spine Journal (14%), and European Spine Journal (13%). The most prolific author was Dr. Todd J Albert (n = 7), with 1,312 citations. The Texas Back Institute was the most productive institution (n = 10). The keywords ACDF, cervical spine, cervical spine, and fusion showed the highest degree of centrality. Conclusion One hundred top-cited articles on ACDF were identified and analyzed in this study. We demonstrate that ACDF is a growing and popular area of research, with the focus of research varying through timeline trends. This will provide a comprehensive and detailed basis for spine surgeons to make clinical decisions and assimilate the research focus of cervical spine surgery.
Collapse
Affiliation(s)
- Zhiyu Ding
- Department of Orthopaedics, The Third Xiangya Hospital, Central South University, Changsha, China
| | - Yijun Ren
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, China
| | - Hongqing Cao
- Department of Spine Surgery, The Third Xiangya Hospital, Central South University, Changsha, China
| | - Jinsong Li
- Department of Spine Surgery, The Third Xiangya Hospital, Central South University, Changsha, China
- Correspondence: Jinsong Li
| |
Collapse
|
|
32
|
Tsalimas G, Evangelopoulos DS, Benetos IS, Pneumaticos S. Dysphagia as a Postoperative Complication of Anterior Cervical Discectomy and Fusion. Cureus 2022; 14:e26888. [PMID: 35978748 PMCID: PMC9375980 DOI: 10.7759/cureus.26888] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/15/2022] [Indexed: 11/05/2022] Open
Abstract
Anterior cervical discectomy and fusion (ACDF), despite its possible complications, remains the gold standard for the surgical treatment of patients with radiculopathy and/or myelopathy caused by cervical intervertebral disc herniation or spondylosis. Despite its high rate of incidence, postoperative dysphagia following ACDF is still poorly understood; its pathogenesis remains relatively unknown, and its risk factors are still a subject of debate. The aim of this study is to review the incidence, pathogenesis, diagnosis, and methods of prevention of dysphagia in ACDF patients. To this end, a literature review was conducted based on the PubMed internet database. Article titles were searched by using the following keywords: “dysphagia” and “anterior cervical discectomy and fusion” or “ACDF”. The search was limited to prospective clinical studies evaluating dysphagia after ACDF surgery. Studies published in non-English languages, retrospective studies, cadaveric studies, reviews, case reports, study protocols, and commentary studies were excluded. Initially, 335 studies were identified after a primary search. After the application of the exclusion criteria, 73 studies remained for the final analysis. This literature review focused on identifying the rate of dysphagia and the various risk factors leading to this complication by comparing and evaluating the current literature with a wide spectrum of heterogeneity concerning patients, surgeons, and surgical techniques. A mean dysphagia rate of 19.4% (95% CI: 9.6%-29.1%) based on the findings of the included studies correlating dysphagia directly with ACDF procedures was calculated. Various established risk factors leading to dysphagia include the female sex, smoking, the surgical approach, rhBMP-2 use, and multilevel surgery, while zero-profile devices seem to reduce dysphagia risk. The diagnosis is based on clinical and radiological findings, especially prevertebral soft-tissue swelling. However, videofluoroscopic and endoscopic studies have been recently used for the evaluation of dysphagia. The role of local administration of steroids in the prevention of dysphagia has not yet been clarified. This review underscores the prevailing rudimentary understanding of the problem of dysphagia after ACDF procedures and highlights the need for more sensitive, factor-specific studies for understanding the impact of various risk factors on the incidence rate of dysphagia.
Collapse
|
|
33
|
Midterm osteolysis-induced aseptic failure of the M6-C™ cervical total disc replacement secondary to polyethylene wear debris. 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 2022; 31:1273-1282. [PMID: 35020078 DOI: 10.1007/s00586-021-07094-7] [Citation(s) in RCA: 18] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/11/2021] [Accepted: 12/18/2021] [Indexed: 10/19/2022]
Abstract
BACKGROUND According to published meta-analyses, cervical total disc replacement (CTDR) seems to be superior to anterior cervical decompression and fusion (ACDF) in most clinical parameters. Despite short-term clinical success of CTDR, there are concerns regarding long-term durability of these prostheses. METHODS This prospective study involved 382 patients who received standalone CTDR or a hybrid procedure (ACDF/CTDR). A retrospective comparison between different CTDR devices was conducted regarding patient-reported outcome measures (PROMs), failure scenarios, and revision surgeries. The M6-C™ Artificial Cervical Disc (Orthofix, Lewisville, Texas) cohort was compared to the other CTDR devices clinically. Etiological reasons for revision, and the surgical technique of the revision was investigated. RESULTS Fifty-three patients received M6-C CTDR. Eighteen patients (34%) were revised at an average of 67 months postoperatively for wear-induced osteolysis. There were three additional cases of pending revision. The PROMs of the two groups were similar, indicating that the failure mode (wear-induced osteolysis) is often asymptomatic. The demographics of the two groups were also similar, with more women undergoing revision surgery than men. There were three one-level CTDR, four two-level hybrids, seven three-level hybrids, and three four-level hybrids revised anteriorly. Sixteen patients underwent removal of the prosthesis and were treated according to the extent of osteolysis. There were four vertebrectomies, six revisions to ACDF, and six revisions to another CTDR. One patient underwent supplemental fixation using a posterior approach. The other CTDR cohort had an incidence of 3.3% at the equivalent time, and none of these were due to osteolysis or wear-related events. CONCLUSIONS There is a concerning midterm failure rate related to ultra-high-molecular-weight-polyethylene wear-induced osteolysis in the M6-C. Patients implanted with the M6-C prosthesis should be contacted, informed, and clinically and radiologically assessed.
Collapse
|
|
34
|
Alluri RK, Vaishnav AS, Sivaganesan A, Albert TJ, Huang RC, Qureshi SA. Cervical Disc Replacement for Radiculopathy Versus Myeloradiculopathy: An MCID Analysis. Clin Spine Surg 2022; 35:170-175. [PMID: 35507951 DOI: 10.1097/bsd.0000000000001313] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2022] [Accepted: 03/01/2022] [Indexed: 11/27/2022]
Abstract
STUDY DESIGN Retrospective cohort study. OBJECTIVES The aim was to compare the minimally clinically important difference (MCID) across multiple patient-reported outcomes (PROs) in patients undergoing cervical disc replacement (CDR) for cervical spondylotic radiculopathy versus myeloradiculopathy. SUMMARY OF BACKGROUND DATA To date, a limited number of studies have demonstrated mostly similar results in patients with cervical spondylotic radiculopathy or myeloradiculopathy undergoing CDR. However, each of these previous studies have focused on statistically significant differences, which may not correlate with patient perceived improvements in outcomes or success. METHODS Patients who underwent 1 or 2-level CDR with radiculopathy versus myeloradiculopathy were identified, and prospectively collected data was retrospectively reviewed. Demographic variables, preoperative diagnosis, and operative variables were collected for each patient. The following PROs were prospectively collected: Neck Disability Index (NDI), visual analog scale (VAS)-Neck, VAS-Arm, Short Form-12 Health Survey (SF-12) Physical Component Score (PCS), SF-12 Mental Component Score (MCS), PROMIS Physical Function (PF). An MCID analysis of PROs for each diagnosis group was performed and the percentage of patients achieving the MCID was compared between the two diagnosis groups. RESULTS Eight-five patients, of which 56% had radiculopathy and 44% had myeloradiculopathy. MCID analysis demonstrated that at 6-week, 12-week, and final postoperative follow-up there was no significant difference in the percentage of patients with radiculopathy or myeloradiculopathy achieving the MCID for each PRO assessed. In both diagnosis groups the percentage of patients achieving the MCID for each PRO continued to increase from the 6-week to final postoperative follow-up except for the SF-12 MCS in patients with myeloradiculopathy. CONCLUSIONS The percentage of patients achieving the MCID was not significantly different at each postoperative period assessed in the radiculopathy and myeloradiculopathy groups treated with CDR. In addition, the percentage of patients achieving the MCID continued to increase from 6 weeks to final follow-up in both groups for almost all PROs assessed.
Collapse
Affiliation(s)
| | | | | | - Todd J Albert
- Hospital for Special Surgery
- Weill Cornell Medical College, New York, NY
| | - Russel C Huang
- Hospital for Special Surgery
- Weill Cornell Medical College, New York, NY
| | - Sheeraz A Qureshi
- Hospital for Special Surgery
- Weill Cornell Medical College, New York, NY
| |
Collapse
|
|
35
|
Schupper AJ, Steinberger J, Gologorsky Y. Multilevel Cervical Arthroplasty: Expanding Indications. World Neurosurg 2022; 164:116. [PMID: 35460905 DOI: 10.1016/j.wneu.2022.04.076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Affiliation(s)
- Alexander J Schupper
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | - Jeremy Steinberger
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | - Yakov Gologorsky
- Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
| |
Collapse
|
|
36
|
Kumar N, Liu ZJ, Poon WS, Park CK, Lin RM, Cho KS, Niu CC, Chen HY, Madhu S, Shen L, Sun Y, Mak WK, Lin CL, Lee SB, Park CK, Lee DC, Tung FI, Wong HK. ProDisc–C versus anterior cervical discectomy and fusion for the surgical treatment of symptomatic cervical disc disease: two-year outcomes of Asian prospective randomized controlled multicentre study. 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 2022; 31:1260-1272. [DOI: 10.1007/s00586-021-07055-0] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/12/2021] [Revised: 10/24/2021] [Accepted: 11/08/2021] [Indexed: 11/24/2022]
|
|
37
|
A meta-analysis comparing the short- and mid- to long-term outcomes of artificial cervical disc replacement(ACDR) with anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease. INTERNATIONAL ORTHOPAEDICS 2022; 46:1609-1625. [PMID: 35113188 DOI: 10.1007/s00264-022-05318-z] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/16/2021] [Accepted: 01/23/2022] [Indexed: 02/05/2023]
Abstract
PURPOSE Anterior cervical discectomy and fusion (ACDF) surgery is commonly performed to treat cervical degenerative disc disease (CDDD). The lost of range of motion (ROM) is also found after ACDF, which contributes to degenerate in adjacent segment disease (ASD). Artificial cervical disc replacement (ACDR), an alternative to ACDF, is developed to preserve the ROM and reduce ASD. This article aims to compare the outcomes between ACDR and ACDF in the short-, mid-, and long-term. METHODS Databases including Cochrane, Embase, PubMed, and Web of Science were searched. Only RCTs were included in this meta-analysis, and the search strategy followed the requirements of the Cochrane Handbook. The strength of evidence was assessed using GRADE. Two reviewers independently assessed the methodological quality of each included study and extracted the relevant data. RESULTS Thirty prospective RCTs were included. Prolonged operative duration, better overall success, neurological success, and NDI success rates were found in ACDR group in all follow-up periods, with lower dysphagia/dysphonia during short-term follow-up. Moreover, a lower ASD was found in ACDR group during long-term follow-up and overall analysis, with lower reoperation rates in all follow-up periods. Comparable length of hospital stay and blood loss were found in both groups. Moreover, ASD was similar in short- and mid-term follow-ups, while dysphagia/dysphonia incidence was similar in mid- and long-term follow-ups. The incidence of implant events was comparable in all follow-up periods (p > 0.05). CONCLUSIONS ACDR is as effective as ACDF and superior for some success rates. Disc replacement can reduce the risk of dysphagia/dysphonia, ASD, and re-operation.
Collapse
|
|
38
|
Abstract
The first US Food and Drug Administration (FDA) approval for cervical total disc replacement (CTDR) was issued in 2007. Since then, 8 more artificial discs have been granted FDA approval for single-level CTDR. Two of these have also been approved for 2-level CTDR. All devices are indicated for levels C3 to C7 for symptomatic patients with radiculopathy or myelopathy caused by disc herniation or spondylosis unresponsive to conservative management. Trials have shown noninferiority of CTDR compared with anterior cervical decompression and fusion in their overall success. Hybrid surgery and CTDR of 3 or more levels are not FDA approved.
Collapse
|
|
39
|
DeVine JG, Agochukwu UF, Jackson KL. Device profile of the sapphire X TM anterior cervical plate system: overview of its safety and efficacy. Expert Rev Med Devices 2021; 18:915-920. [PMID: 34432546 DOI: 10.1080/17434440.2021.1971970] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
Introduction:The Sapphire X Anterior Cervical Plate System is a new medical device designed to provide stability after anterior discectomy and fusion procedures. It has unique benefits over many of the more established plates on the market. It is manufactured predominantly from titanium alloy and was first launched in late 2020.Areas covered:The structure and unique features of the Sapphire X are described. The indications for its use are discussed. The delivery system designed for the plate is reviewed in detail. Research outlining the shortcomings of current plate technologies and alternative technologies in this market space are reviewed.Expert Opinion:The evidence in this article demonstrates the risk of adjacent-level ossification development (ALOD) with current cervical plate designs. The industry is saturated with cervical plate technologies, yet there are very few plates small enough to avoid encroaching upon adjacent levels of disc space, particularly in the upper subaxial cervical segments and in patients with small vertebrae. This device review demonstrates the successful application of a cervical plate device that is small enough to avoid encroachment on the adjacent-level disc spaces while providing immediate stability after discectomy and fusion in the cervical spine.
Collapse
Affiliation(s)
- John G DeVine
- Spine Surgery, Department of Orthopedic Surgery, Medical College of Georgia, Augusta University, Augusta, GA, United States
| | - Uzondu F Agochukwu
- Minimally Invasive Spine Surgery, Department of Orthopedic Surgery, Medical College of Georgia, Augusta University, Augusta, Ga, United States
| | - Keith L Jackson
- Uniformed Services University of the Health Sciences, Chief, Spine Surgery, Department of Orthopedic Surgery, Dwight D. Eisenhower Army Medical Center, Augusta, GA, United States
| |
Collapse
|
|
40
|
Sheng XQ, Meng Y, Liu H, Wang BY, Yang Y, Rong X, Hong Y. Is the fusion order of the cranial and caudal levels different in two-level anterior cervical discectomy and fusion for cervical spondylopathy? A retrospective study. J Orthop Surg Res 2021; 16:500. [PMID: 34399814 PMCID: PMC8365930 DOI: 10.1186/s13018-021-02657-2] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/25/2021] [Accepted: 08/05/2021] [Indexed: 02/08/2023] Open
Abstract
STUDY DESIGN Retrospective study. OBJECTIVE This study aimed to compare the fusion order between the cranial and caudal levels in two-level anterior cervical discectomy and fusion (ACDF) with a zero-profile device in the treatment of cervical spondylopathy. Fusion is the standard used to judge the success of ACDF. However, the fusion order in two-level ACDF remains uncertain. The mechanical environment of different levels is different, which may affect the fusion rate or fusion order. METHODS From 2014 to January 2019, data of consecutive patients with two-level cervical disk degenerative disease who underwent ACDF were retrospectively reviewed. Radiological assessments were based on the range of motion of the fusion level, segment slope, and disk height, and complications were assessed. Data were analyzed using the paired t, Mann-Whitney U, χ2, Fisher exact, and rank-sum tests and logistic regression analysis. RESULTS In total, 118 patients were ultimately enrolled for analysis in the study. The respective fusion rates of the cranial and caudal levels were 26.27% and 10.17% (p < 0.05) at 3 months, 58.47% and 42.37% (p < 0.05) at 6 months, 86.44% and 82.20% (1 0.05) at 1 year, and 92.37% and 89.83% (p > 0.05) at the last follow-up. Multivariate logistic regression analysis indicated that the preoperative segmental slope and cranial level were independent risk factors for non-fusion. The adjacent segment degeneration (ASD) and subsidence rates were comparable between the two levels. CONCLUSION The caudal level had a slower fusion process than the cranial level. A higher preoperative segment slope was a risk factor for fusion. However, the subsidence and ASD rate were comparable between the caudal and cranial levels in the two-level ACDF.
Collapse
Affiliation(s)
- Xia-Qing Sheng
- Department of Orthopedic Surgery, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China
| | - Yang Meng
- Department of Orthopedic Surgery, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China
| | - Hao Liu
- Department of Orthopedic Surgery, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China.
| | - Bei-Yu Wang
- Department of Orthopedic Surgery, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China
| | - Yi Yang
- Department of Orthopedic Surgery, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China
| | - Xin Rong
- Department of Orthopedic Surgery, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China
| | - Ying Hong
- West China School of Nursing, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China
- Department of Anesthesia and Operation Center, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China
| |
Collapse
|
|
41
|
Ku J, Ku J, Chang HK, Wu JC. Cervical disc arthroplasty at C2–3: illustrative case. JOURNAL OF NEUROSURGERY: CASE LESSONS 2021; 2:CASE21320. [PMID: 36131581 PMCID: PMC9563647 DOI: 10.3171/case21320] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/23/2021] [Accepted: 06/09/2021] [Indexed: 11/06/2022]
Abstract
BACKGROUND
Since the beginning of the 21st century, cervical disc arthroplasty (CDA) has been accepted as an alternative to anterior cervical discectomy and fusion for surgical management of disc problems. The published clinical trials of CDA have included patients with radiculopathy or myelopathy caused by one- or two-level disc herniation at C3–7. However, it remains uncertain whether CDA is a viable option for C2–3 disc herniation.
OBSERVATIONS
In this report, a 52-year-old man presented with hand numbness, arm pain, and myelopathic symptoms that were refractory to medical treatment for more than 6 months. The magnetic resonance images demonstrated herniated discs at C2–3, C3–4, and C4–5, causing stenosis. There was no ossification of posterior longitudinal ligament and the spine was mobile, so he received anterior discectomies with artificial disc replacement at each of the C2–3, C3–4, and C4–5 levels. The surgery went smoothly, and his neurological symptoms were promptly relieved. The postoperative radiographs at 24 months demonstrated a preserved range of motion at each level.
LESSONS
To date, this was the first report of CDA performed at C2–3, which also involved three consecutive levels of disc replacement. The report suggested that both C2–3 and three-consecutive-level CDA may be a viable option for cervical disc disease.
Collapse
Affiliation(s)
- Jason Ku
- Department of Life Sciences, University of California, Los Angeles, California
| | - Johnson Ku
- Department of Life Sciences, University of California, Los Angeles, California
| | - Hsuan-Kan Chang
- Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan
- College of Medicine
- Department of Biomedical Imaging and Radiological Sciences, and
| | - Jau-Ching Wu
- Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan
- College of Medicine
- Institute of Pharmacology, National Yang Ming Chiao Tung University, Taipei, Taiwan
| |
Collapse
|
|
42
|
Johansen TO, Sundseth J, Fredriksli OA, Andresen H, Zwart JA, Kolstad F, Pripp AH, Gulati S, Nygaard ØP. Effect of Arthroplasty vs Fusion for Patients With Cervical Radiculopathy: A Randomized Clinical Trial. JAMA Netw Open 2021; 4:e2119606. [PMID: 34351401 PMCID: PMC8343489 DOI: 10.1001/jamanetworkopen.2021.19606] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2023] Open
Abstract
IMPORTANCE Surgical treatment for cervical radiculopathy is increasing. Treatment with motion preserving anterior cervical disc arthroplasty was introduced to prevent symptomatic adjacent segment disease, and there is need to evaluate results of this treatment compared with standard anterior cervical discectomy and fusion. OBJECTIVE To investigate clinical outcomes at 5 years for arthroplasty vs fusion in patients who underwent surgical treatment for cervical radiculopathy. DESIGN, SETTING, AND PARTICIPANTS This multicenter, single-blinded, randomized clinical trial included patients aged 25 to 60 years with C6 or C7 radiculopathy referred to study sites' outpatient clinics from 2008 to 2013. Data were analyzed from December 2019 to December 2020. INTERVENTIONS Patients were randomly assigned to arthroplasty or fusion. Patients were blinded to which treatment they received. The surgical team was blinded until nerve root decompression was completed. MAIN OUTCOMES AND MEASURES The primary end point was change in Neck Disability Index (NDI) score. Secondary outcomes were arm and neck pain, measured with numeric rating scales (NRS); quality of life, measured with the EuroQol-5D (EQ-5D); reoperation rates; and adjacent segment disease. RESULTS Among 147 eligible patients, 4 (2.7%) declined to participate and 7 (4.8%) were excluded. A total of 136 patients were randomized (mean [SD] age, 44.1 [7.0] years; 73 (53.7%) women), with 68 patients randomized to arthroplasty and 68 patients randomized to fusion. A total of 114 patients (83.8%) completed the 5-year follow-up. In the arthroplasty group, the mean NDI score was 45.9 (95% CI, 43.3 to 48.4) points at baseline and 22.2 (95% CI, 18.0 to 26.3) points at 5 years follow-up, and in the fusion group, mean NDI score was 51.3 (95% CI, 48.1 to 54.4) points at baseline, and 21.3 (95% CI, 17.0 to 25.6) points at 5 years follow-up. The changes in mean NDI scores between baseline and 5 years were statistically significant for arthroplasty (mean change, 24.8 [95% CI, 19.8 to 29.9] points; P < .001) and fusion (mean change, 29.9 [95% CI, 24.0 to 35.9] points; P < .001), but the change in mean NDI scores was not significantly different between groups (difference, 5.1 [95% CI, -2.6 to 12.7] points; P = .19). There were no significant differences in changes in arm pain (mean [SE] change, 3.5 [0.5] vs 3.1 [0.4]; P = .47), neck pain (mean [SE] change, 3.0 [0.5] vs 3.4 [0.5]; P = .50), EQ-5D (mean [SE] change, 0.39 [0.4] vs 0.45 [0.6]; P = .46), patients requiring reoperation (10 patients [14.7%] vs 8 patients [11.8%]; P = .61), and adjacent segment disease (0 patients vs 1 patient [1.5%]; P = .32) between the arthroplasty and fusion groups. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, patients treated with arthroplasty and fusion reported similar and substantial clinical improvement at 5 years. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00735176.
Collapse
Affiliation(s)
- Tonje Okkenhaug Johansen
- Department of Neurosurgery, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
- Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway
| | - Jarle Sundseth
- Department of Neurosurgery, Oslo University Hospital Rikshospitalet, Oslo, Norway
| | - Oddrun Anita Fredriksli
- Department of Neurosurgery, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
- Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway
| | - Hege Andresen
- Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway
- National Advisory Unit on Spinal Surgery, St Olav’s Hospital, Trondheim University Hospital, Trondheim, Norway
| | - John-Anker Zwart
- Faculty of Medicine, University of Oslo, Oslo, Norway
- Division of Clinical Neuroscience, Department of Research and Innovation, Oslo University Hospital, Oslo, Norway
| | - Frode Kolstad
- Department of Neurosurgery, Oslo University Hospital Rikshospitalet, Oslo, Norway
| | - Are Hugo Pripp
- Research Support Services, Oslo Centre of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway
| | - Sasha Gulati
- Department of Neurosurgery, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
- Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway
- National Advisory Unit on Spinal Surgery, St Olav’s Hospital, Trondheim University Hospital, Trondheim, Norway
| | - Øystein Petter Nygaard
- Department of Neurosurgery, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
- Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway
- National Advisory Unit on Spinal Surgery, St Olav’s Hospital, Trondheim University Hospital, Trondheim, Norway
| |
Collapse
|
|
43
|
Couch BK, Wawrose RA, LeVasseur CM, Pitcairn SW, Shaw JD, Donaldson WF, Lee JY, Anderst WJ. Residual Motion and Graft Type Do Not Influence Patient-reported Outcomes Following One- or Two-level Anterior Cervical Discectomy and Fusion. Spine (Phila Pa 1976) 2021; 46:E817-E825. [PMID: 34228692 DOI: 10.1097/brs.0000000000003918] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Prospective cohort. OBJECTIVE The aim of this study was to determine the effect of graft type on residual motion and the relationship among residual motion, smoking, and patient-reported outcome (PRO) scores following anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA Although most patients develop solid fusion based on static imaging following ACDF, dynamic imaging has revealed that many patients continue to have residual motion at the arthrodesis. METHODS Forty-eight participants performed dynamic neck flexion/extension and axial rotation within a biplane radiography system 1 year following ACDF (21 one-level, 27 two-level). PRO scores included the Short Form-36, Neck Disability Index, and Cervical Spine Outcomes Questionnaire. An automated model-based tracking process matched subject-specific bone models to the biplane radiographs with sub-millimeter accuracy. Residual motion was measured across the entire arthrodesis site for both one- and two-level fusions in patients who received either allograft or autograft. Patients were divided into "pseudarthrosis" (>3° of flexion/extension residual motion) and "solid fusion" groups. Residual motion and PROs were compared between groups using Student t tests. RESULTS Patients who received allograft showed more total flexion/extension residual motion (4.1° vs. 2.8°, P = 0.12), although this failed to reach significance. No differences were noted in PROs based on graft type (all P > 0.08) or the presence of pseudarthrosis (all P > 0.13). No differences were noted in residual motion between smokers and nonsmokers (all P > 0.15); however, smokers who received allograft reported worse outcomes than nonsmokers who received allograft and smokers who received autograft. CONCLUSION Allograft may result in slightly more residual motion at the arthrodesis site 1 year after ACDF. However, there is minimal evidence that PROs are adversely affected by slightly increased residual motion, suggesting that the current definition of pseudarthrosis correlates poorly with clinically significant findings. Additionally, autograft appears to result in superior outcomes in patients who smoke.Level of Evidence: 2.
Collapse
Affiliation(s)
- Brandon K Couch
- Department of Orthopedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA
| | | | | | | | | | | | | | | |
Collapse
|
|
44
|
Guyer RD, Coric D, Nunley PD, Sasso RC, Musacchio M, Bae HW, Peloza JH, Ohnmeiss DD. Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up. Int J Spine Surg 2021; 15:633-644. [PMID: 34281951 DOI: 10.14444/8084] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/25/2023] Open
Abstract
BACKGROUND Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core. The purpose of this study was to compare this TDR with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration. METHODS This was a prospective, nonrandomized, historically controlled, multicenter US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n = 150). The historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial. The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analog scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI. RESULTS The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; P < .001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points. There were no significant differences in the rates of serious adverse events. The range of motion of the TDR level had increased significantly by 3 months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from preoperation. CONCLUSIONS The TDR had an acceptable safety profile and a significantly greater composite success rate than ACDF. These results support that the PEEK-on-ceramic TDR is a viable alternative to ACDF for single-level symptomatic disc degeneration. CLINICAL RELEVANCE This study found that the PEEK-on-ceramic TDR is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion. LEVEL OF EVIDENCE 2.
Collapse
Affiliation(s)
- Richard D Guyer
- Center for Disc Replacement at Texas Back Institute, Plano, Texas
| | - Domagoj Coric
- Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina
| | | | | | | | - Hyun W Bae
- The Spine Institute, Los Angeles, California
| | | | - Donna D Ohnmeiss
- Center for Disc Replacement at Texas Back Institute, Plano, Texas.,Texas Back Institute Research Foundation, Plano, Texas
| |
Collapse
|
|
45
|
Abstract
STUDY DESIGN Retrospective cohort study. OBJECTIVE The aim of the study was to assess which factors increase risk of readmission within 30 days of surgery or prolonged length of stay (LOS) (≥2 days) after cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA Several studies have shown noninferiority at mid- and long-term outcomes after cervical disc arthroplasty (CDA) compared to anterior cervical discectomy and fusion ACDF, but few have evaluated short-term outcomes regarding risk of readmission or prolonged LOS after surgery. METHODS Demographics, comorbidities, operative details, postoperative complications, and perioperative outcomes were collected for patients undergoing single level CDA in the National Surgical Quality Improvement Program (NSQIP) database. Patients with prolonged LOS, defined as >2 days, and readmission within 30 days following CDA were identified. Univariable and multivariable logistic regression models were used to identify risk factors for prolonged LOS and readmission. RESULTS A total of 3221 patients underwent single level CDA. Average age was 45.6 years (range 19-82) and 53% of patients were male. A total of 472 (14.7%) experienced a prolonged LOS and 36 (1.1%) patients were readmitted within 30 days following surgery. Predictors of readmission were postoperative superficial wound infection (odds ratio [OR] = 73.83, P < 0.001), American Society of Anesthesiologists (ASA) classification (OR = 1.98, P = 0.048), and body mass index (BMI) (OR = 1.06, P = 0.02). Female sex (OR = 1.76, P < 0.001), diabetes (OR = 1.50, P = 0.024), postoperative wound dehiscence (OR = 13.11, P = 0.042), ASA class (OR = 1.43, P < 0.01), and operative time (OR = 1.01, P < 0.001) were significantly associated with prolonged LOS. CONCLUSION From a nationwide database analysis of 3221 patients, wound complications are predictors of both prolonged LOS and readmission. Patient comorbidities, including diabetes, higher ASA classification, female sex, and higher BMI also increased risk of prolonged LOS or readmission.Level of Evidence: 3.
Collapse
|
|
46
|
Hegmann KT, Travis R, Andersson GBJ, Belcourt RM, Carragee EJ, Eskay-Auerbach M, Galper J, Goertz M, Haldeman S, Hooper PD, Lessenger JE, Mayer T, Mueller KL, Murphy DR, Tellin WG, Thiese MS, Weiss MS, Harris JS. Invasive Treatments for Low Back Disorders. J Occup Environ Med 2021; 63:e215-e241. [PMID: 33769405 DOI: 10.1097/jom.0000000000001983] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
OBJECTIVE This abbreviated version of the American College of Occupational and Environmental Medicine's Low Back Disorders guideline reviews the evidence and recommendations developed for invasive treatments used to manage low back disorders. METHODS Comprehensive systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking and often relied on analogy to other disorders for which evidence exists. A total of 47 high-quality and 321 moderate-quality trials were identified for invasive management of low back disorders. RESULTS Guidance has been developed for the invasive management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 49 specific recommendations. CONCLUSION Quality evidence should guide invasive treatment for all phases of managing low back disorders.
Collapse
Affiliation(s)
- Kurt T Hegmann
- American College of Occupational and Environmental Medicine, Elk Grove Village, Illinois
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
47
|
Schroeder GD, Vaccaro AR, Divi SN, Reyes AA, Goyal DKC, Phillips FM, Zigler J. 2021 Position Statement From the International Society for the Advancement of Spine Surgery on Cervical and Lumbar Disc Replacement. Int J Spine Surg 2021; 15:37-46. [PMID: 33900955 DOI: 10.14444/8004] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/07/2023] Open
Affiliation(s)
- Gregory D Schroeder
- Rothman Institute at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
| | - Alexander R Vaccaro
- Rothman Institute at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
| | | | - Ariana A Reyes
- Rothman Institute at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
| | - Dhruv K C Goyal
- Rothman Institute at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
| | - Frank M Phillips
- Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois
| | | |
Collapse
|
|
48
|
Muthu S, Ramakrishnan E. Fragility Analysis of Statistically Significant Outcomes of Randomized Control Trials in Spine Surgery: A Systematic Review. Spine (Phila Pa 1976) 2021; 46:198-208. [PMID: 32756285 DOI: 10.1097/brs.0000000000003645] [Citation(s) in RCA: 20] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
STUDY DESIGN Systematic review. OBJECTIVES The aim of this study was to assess the robustness of statistically significant outcomes from randomized control trials (RCTs) in spine surgery using Fragility Index (FI) which is a novel metric measuring the number of events upon which statistical significance of the outcome depends. SUMMARY OF BACKGROUND DATA Many trials in Spine surgery were characterized by fewer outcome events along with small sample size. FI helps us identify the robustness of the results from such studies with statistically significant dichotomous outcomes. METHODS We conducted independent and in duplicate, a systematic review of published RCTs in spine surgery from PubMed Central, Embase, and Cochrane Database. RCTs with 1:1 prospective study design and reporting statistically significant dichotomous primary or secondary outcomes were included. FI was calculated for each RCT and its correlation with various factors was analyzed. RESULTS Seventy trials met inclusion criteria with a median sample size of 133 (interquartile range [IQR]: 80-218) and median reported events per trial was 38 (IQR: 13-94). The median FI score was 2 (IQR: 0-5), which means if we switch two patients from nonevent to event, the statistical significance of the outcome is lost. The FI score was less than the number of patients lost to follow-up in 28 of 70 trials. The FI score was found to positively correlated with sample size (r = 0.431, P = 0.001), total number of outcome events (r = 0.305, P = 0.01) while negatively correlated with P value (r = -0.392, P = 0.001). Funding, journal impact-factor, risk of bias domains, and year of publication did not have a significant correlation. CONCLUSION Statistically significant dichotomous outcomes reported in spine surgery RCTs are more often fragile and outcomes of the patients lost to follow-up could have changed the significance of results and hence it needs caution before transcending their results into clinical application. The addition of FI in routine reporting of RCTs would guide readers on the robustness of the statistical significance of outcomes. RCTs with FI ≥5 without any patient lost to follow-up can be considered to have clinically robust results.Level of Evidence: 1.
Collapse
Affiliation(s)
- Sathish Muthu
- Government Hospital, Velayuthampalayam, Karur, Tamil Nadu, India
| | - Eswar Ramakrishnan
- Institute of Orthopaedics and Traumatology, Madras Medical College & Rajiv Gandhi Government General Hospital, Chennai, Tamil Nadu, India
| |
Collapse
|
|
49
|
Virk S, Phillips F, Khan S, Qureshi S. A cross-sectional analysis of 1347 complications for cervical disc replacements from medical device reports maintained by the United States Food and Drug Administration. Spine J 2021; 21:265-272. [PMID: 32966907 DOI: 10.1016/j.spinee.2020.09.005] [Citation(s) in RCA: 24] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/04/2020] [Accepted: 09/14/2020] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Cervical disc replacement (CDR) has increased in popularity over the past decade based on published outcomes from FDA IDE studies with narrowly defined inclusion and exclusion criteria. A low rate of complications was noted in these studies. The broader complication profile for CDR in widespread clinical practice has yet to be described. PURPOSE To outline the complications reported to the FDA regarding commonly used CDR products STUDY DESIGN/SETTING: Retrospective database review PATIENT SAMPLE: Nationwide database of reported complications related to CDR products from patients across the country OUTCOME MEASURES: Complications related to CDR METHODS: We queried the MAUDE database and Alternative Summary Reporting (ASR) data files submitted between January 2005 to March 2020. The complications listed for seven FDA-approved CDR implants were analyzed. The entries in the databases were cataloged for complication type, date of entry, source of report, and whether the investigation was "complete". Reports that had too little information to extract relevant data were excluded. RESULTS There were 1,517 entries identified in the MAUDE database. After removal of duplicate entries and entries without sufficient information, there were 1,347 entries analyzed. The top five complications were (1) migration of implant (338 entries, 25.2%) (2) insertion problem/failure (312 entries, 23.3%) (3) neck pain (203 entries, 15.2%) (4) heterotopic ossification (108 entries, 8.1%) and (5) radiculopathy (90 entries, 8.1%). The number of analyzed implant-related MAUDE entries and most common implant-related complication for each implant was 209 entries for insertion problem/failure for Mobi-C; 158 entries for migration of implant for ProDisc-C; 154 entries for insertion problem/failure for Bryan cervical disc; 130 entries for migration of implant for Prestige cervical disc; 49 entries for migration of implant for PCM cervical disc; 12 entries for migration of implant for M6 and 10 entries for migration of implant for Secure-C. Only 263 entries (19.5%) were deemed "complete". Most entries were from the manufacturer/company representative/distributor (923 entries, 70%). There were no entries related to cervical disc replacement devices within the ASR data. CONCLUSIONS The MAUDE database highlights complications related to CDR implants that may not be emphasized in currently published studies. It is important to understand this broad complication profile for CDR to ensure safe utilization of this new technology.
Collapse
Affiliation(s)
- Sohrab Virk
- Hospital for Special Surgery, Department of Orthopedic Surgery, New York, NY, USA; Northwell Health, Department of Orthopedic Surgery, Great Neck, NY.
| | - Frank Phillips
- Department of Orthopedic Surgery, Rush University, Chicago, IL, USA
| | - Safdar Khan
- Department of Orthopedic Surgery, Ohio State University, Columbus, OH, USA
| | - Sheeraz Qureshi
- Hospital for Special Surgery, Department of Orthopedic Surgery, New York, NY, USA
| |
Collapse
|
|
50
|
Abstract
STUDY DESIGN A bibliometric review of current literature. OBJECTIVE The purpose of this study was to identify and analyze the 100 most cited articles in spinal disc arthroplasty (SDA) research. SUMMARY OF BACKGROUND DATA In the last several decades, SDA has been widely performed all over the world, with increasing popularity of cervical disc arthroplasty (CDA). While there is a large number of articles on this topic, to our knowledge, there is no bibliometric analysis yet. METHODS All databases from the Web of Science were searched in a three-step approach. The information of the 100 most cited studies was collected, including title, first and last author, year of publication, journal, total citations, geographic origin, subspecialty, and types of artificial intervertebral disc for further analysis. RESULTS The 100 most-cited articles were published from 1966 to 2015 in 9 different journals and were cited from 66 to 346 times. A total of 11 countries contributed to the 100 articles and the United States topped the list, with 54 articles, followed by Germany and France, with 10 and nine articles, respectively. There were more studies in CDA (n = 53) than lumbar disc arthroplasty (n = 35). Most of the studies reported clinical and radiographic outcomes (n = 33). The most productive periods were from 2006 to 2010. The majority of publications were in Spine, which published 43 articles. In total, 12 authors published more than two articles on the list. CONCLUSION Of the top 100 most cited articles on SDA, cervical papers outnumbered lumbar articles and the United States had 55 articles, with no other countries having more than 10. Our paper can help readers determine which of the thousands of articles on this topic are the most impactful and important ones to be familiar with. LEVEL OF EVIDENCE 3.
Collapse
|