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Saraf A, Hussain A, Mahipal V, Agarwal T, Kush A. The Multiple Dosing Effects of Platelet-Rich Plasma on Cartilage Regeneration in Knee Osteoarthritis: Randomised, Placebo-Controlled Trial. Malays Orthop J 2025; 19:11-20. [PMID: 40291970 PMCID: PMC12022701 DOI: 10.5704/moj.2503.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2023] [Accepted: 08/07/2024] [Indexed: 04/30/2025] Open
Abstract
Introduction The purpose of this study was to evaluate clinical and biochemical efficacy of autologous intraarticular (IA) platelet rich plasma (PRP) compared to saline and to measure effectiveness of single and multiple doses given at monthly intervals for Kellgren-Lawrence (K-L) grade II, III knee osteoarthritis (KOA). Material and Methods A total of 130 patients were randomised into 4 groups; PRP-1 (n=36), PRP-2 (n=34), PRP-3 (n=32) and saline (NS) (n=28), after approval from institute ethics committee (reference number: TMU/IEC/20-21/091) and was conducted in accordance with Helsinki declaration. Groups PRP-1, PRP-2, PRP-3 received single, double and triple injections of PRP whereas NS group received single saline (0.9%) injection. Assessment of outcome scores (visual analogue scale [VAS] and Western Ontario and McMaster Universities Arthritis Index [WOMAC]) was done at baseline and three, six, nine months post intervention. Serum collagen 2-1 (Coll2-1) estimation at baseline and nine months post-therapy was used for biochemical assessment. Results Improvement in VAS and WOMAC was statistically significant and clinically meaningful (Minimal clinically important change [MCIC]; >12% of baseline and ≥2cm difference in mean for WOMAC and VAS, respectively) for groups PRP-1, PRP-2 and PRP-3 in comparison to saline (P<0.05), at every follow-up. PRP groups also exhibited a significant decrease in serum Coll2-1 at 9 months (P<0.05). On comparison among the PRP groups, multiple doses (groups PRP-2 and PRP-3) produced significantly better clinical results than single dose (group PRP-1) (P<0.05), whereas the difference in Coll2-1 levels was significant for group PRP-1 vs PRP-3 only (P<0.05). Conclusion PRP results in clinically significant amelioration of functional and pain scores as well as significant reduction in serum levels of Coll2-1 in K-L grade II, III KOA over nine months. These benefits can be accentuated by multiple doses given one month apart.
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Affiliation(s)
- A Saraf
- Department of Orthopaedics, Teerthanker Mahaveer University Medical College and Research Centre, Moradabad, India
| | - A Hussain
- Department of Orthopaedics, Teerthanker Mahaveer University Medical College and Research Centre, Moradabad, India
| | - V Mahipal
- Department of Orthopaedics, Teerthanker Mahaveer University Medical College and Research Centre, Moradabad, India
| | - T Agarwal
- Department of Orthopaedics, Teerthanker Mahaveer University Medical College and Research Centre, Moradabad, India
| | - A Kush
- Department of Orthopaedics, Teerthanker Mahaveer University Medical College and Research Centre, Moradabad, India
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Migliorini F, Pilone M, Ascani J, Schäfer L, Jeyaraman M, Maffulli N. Management of knee osteoarthritis using bone marrow aspirate concentrate: a systematic review. Br Med Bull 2025; 153:ldae016. [PMID: 39506910 DOI: 10.1093/bmb/ldae016] [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: 01/11/2024] [Revised: 08/20/2024] [Accepted: 10/17/2024] [Indexed: 11/08/2024]
Abstract
INTRODUCTION Knee osteoarthritis (OA) is a common degenerative joint condition and a major cause of disability in the general population. SOURCE OF DATA Recent published literature identified from PubMed, EMBASE, Google Scholar, and Scopus. AREAS OF AGREEMENT Orthobiological therapies try to regenerate articular cartilage and stop the progression of the degenerative lesion. Intra-articular injections of biological derivates have been increasingly used in the last decade. AREAS OF CONTROVERSY The indications for the use of bone marrow aspirate concentrate (BMAC) are still unclear. GROWING POINTS We systematically reviewed the current literature on BMAC in the management of knee OA, giving an update on the current indications for the selection of the ideal patient and the preparations and efficacy of BMAC compared to other biological alternatives. AREAS TIMELY FOR DEVELOPING RESEARCH BMAC is a valuable source of mesenchymal stem cells, offering potential benefits in attenuating the inflammatory pathway associated with knee OA. Intra-articular injection of BMAC has shown effectiveness in clinical trials improving functional outcomes of knee OA patients. The superiority of BMAC over other orthobiological treatments cannot be assessed because of conflicting results.
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Affiliation(s)
- Filippo Migliorini
- Department of Orthopaedic and Trauma Surgery, Academic Hospital of Bolzano (SABES-ASDAA), Via Lorenz Böhler 5, 39100, Bolzano, Italy
- Department of Life Sciences, Health, and Health Professions, Link Campus University, Via del Casale di San Pio V, 00165 Rome, Italy
| | - Marco Pilone
- Residency Program in Orthopedics and Traumatology, University of Milan, Via Festa del Perdono 7, 20122 Milan, Italy
| | - Jacopo Ascani
- Department of Trauma and Orthopaedic Surgery, Faculty of Medicine and Psychology, University "La Sapienza" of Rome, Via di Grottarossa 1035, 00189 Roma, Italy
| | - Luise Schäfer
- Department of Orthopaedic and Trauma Surgery, Academic Hospital of Bolzano (SABES-ASDAA), Via Lorenz Böhler 5, 39100, Bolzano, Italy
| | - Madhan Jeyaraman
- Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Poonamallee High Rd, Velappanchavadi, Chennai 600077, Tamil Nadu, India
| | - Nicola Maffulli
- Department of Trauma and Orthopaedic Surgery, Faculty of Medicine and Psychology, University "La Sapienza" of Rome, Via di Grottarossa 1035, 00189 Roma, Italy
- School of Pharmacy and Bioengineering, Keele University Faculty of Medicine, Stoke on Trent ST4 7QB, United Kingdom
- Queen Mary University of London, Barts and the London School of Medicine and Dentistry, Centre for Sports and Exercise Medicine, Mile End Hospital, 275 Bancroft Road, E1 4DG London, UK
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Jain K, Jeyaraman M, Jeyaraman N, Gupta A. Autologous Growth Factor-Rich Concentrate (GFC) Injection in Non-union of Fractures: A Quasi-experimental Study. Indian J Orthop 2024; 58:1833-1843. [PMID: 39664350 PMCID: PMC11628475 DOI: 10.1007/s43465-024-01278-1] [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: 04/08/2024] [Accepted: 09/26/2024] [Indexed: 12/13/2024]
Abstract
INTRODUCTION Non-union fractures represent a significant challenge in orthopedic practice, contributing to considerable morbidity and socioeconomic burden. Traditional treatments, such as autologous bone grafting, are effective but have limitations, including donor-site morbidity and limited tissue availability. Autologous peripheral blood-derived orthobiologics, including growth factor-rich concentrate (GFC), have emerged as a minimally invasive alternative, leveraging the body's natural healing mechanisms by concentrating and applying growth factors directly to the fracture site. This study evaluates the safety and efficacy of GFC injections in the treatment of non-union fractures. MATERIALS AND METHODS This quasi-experimental study included 17 patients with non-union fractures of various long bones, treated under fluoroscopic guidance with three doses of 5 mL GFC injections, administered 2 weeks apart at the non-union site. Demographic data, injury characteristics, and comorbid conditions were recorded. Growth factor levels were quantified via enzyme-linked immunosorbent assay (ELISA), and statistical analyses were conducted to explore associations between the amount of growth factors and treatment outcomes. Radiographic assessments and bony callus appearance were evaluated at the baseline and at 1-, 3-, and 6-month follow-up post-last injection. RESULTS No adverse effects were reported throughout the duration of the study. The majority of patients (82.4%) showed significant improvement, evidenced by enhanced bony callus formation and reduced non-union signs. No significant correlation was found between the specific growth factor levels and the clinical outcomes of non-union of fractures. However, the presence of comorbid conditions significantly influenced treatment efficacy, underscoring the importance of patient selection in clinical practice. CONCLUSION Administration of GFC injection is safe and potentially efficacious for the treatment of non-union fractures, offering an alternative to traditional surgical interventions. These results laid the foundation for prospective, adequately powered, randomized and non-randomized clinical studies with longer follow-up to further establish the efficacy of GFC in patients with non-union fractures. Moreover, formulation protocols need to be optimized while considering patient-specific variables, to ensure reproducibility and repeatability of outcomes from these studies. SUPPLEMENTARY INFORMATION The online version contains supplementary material available at 10.1007/s43465-024-01278-1.
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Affiliation(s)
- Karun Jain
- Pushpanjali Medical Centre, Consultant Orthopaedic Surgeon, Delhi, India
| | - Madhan Jeyaraman
- Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu 600077 India
- South Texas Orthopaedic Research Institute (STORI Inc.), Laredo, TX 78045 USA
| | - Naveen Jeyaraman
- Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu 600077 India
| | - Ashim Gupta
- South Texas Orthopaedic Research Institute (STORI Inc.), Laredo, TX 78045 USA
- Regenerative Orthopaedics, Noida, Uttar Pradesh 201301 India
- Future Biologics, Lawrenceville, GA 30043 USA
- BioIntegarte, Lawrenceville, GA 30043 USA
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Gupta A, Maffulli N. Growth Factor Concentrate (GFC) for the Management of Osteoarthritis of the Knee: A Systematic Review. Indian J Orthop 2024; 58:829-834. [PMID: 38948375 PMCID: PMC11208381 DOI: 10.1007/s43465-024-01172-w] [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: 03/27/2024] [Accepted: 04/24/2024] [Indexed: 07/02/2024]
Abstract
Introduction The knee is the most commonly affected joint in osteoarthritis (OA), affecting millions of people worldwide. Knee OA significantly impacts the activities of daily living (ADL) along with affecting overall quality of life of patients (QoL), thereby leading to substantial socio-economic burden. Conservative therapies are prioritized, resorting to surgery only when needed. However, these traditional approaches have limitations. Regenerative medicine, involving the use of orthobiologics, including autologous peripheral blood-derived orthobiologics such as growth factor concentrate (GFC), has evolved and shown potential for managing knee OA. The primary goal of this review is to summarize the results of in vitro, preclinical and clinical studies involving GFC for the management of knee OA. Methods Multiple databases (PubMed, Scopus, Google Scholar, Web of Science and Embase) were searched applying terms for the intervention 'GFC' and treatment 'knee OA' for the studies published in the English language to March 10, 2024. Results Only three clinical studies met our pre-defined criteria and were included in this review. Conclusion Intra-articular administration of GFC is safe and potentially efficacious to manage OA of the knee. More, adequately powered, multi-center, prospective, RCTs are warranted to demonstrate the long-term effectiveness of GFC in patients suffering from mild-to-moderate knee OA and to justify its routine clinical use. Further studies evaluating the efficacy of GFC compared to other orthobiologics are also required to allow physicians/surgeons to choose the optimal orthobiologic for the treatment of OA of the knee.
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Affiliation(s)
- Ashim Gupta
- Future Biologics, Lawrenceville, GA 30043 USA
- Regenerative Orthopaedics, Noida, 201301 India
- South Texas Orthopaedic Research Institute (STORI Inc.), Laredo, TX 78045 USA
- BioIntegrate, Lawrenceville, GA 30043 USA
| | - Nicola Maffulli
- Department of Trauma and Orthopaedic Surgery, Faculty of Medicine and Psychology, University La Sapienza, 00185 Rome, Italy
- Centre for Sports and Exercise Medicine, Barts and the London School of Medicine and Dentistry, Mile End Hospital, Queen Mary University of London, London, E1 4DG UK
- School of Pharmacy and Bioengineering, Keele University School of Medicine, Stoke On Trent, ST4 7QB UK
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Gupta A, Jain VK. Autologous peripheral blood-derived orthobiologics: Different types and their effectiveness in managing knee osteoarthritis. World J Orthop 2024; 15:400-403. [PMID: 38835681 PMCID: PMC11145965 DOI: 10.5312/wjo.v15.i5.400] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Revised: 02/26/2024] [Accepted: 04/08/2024] [Indexed: 05/15/2024] Open
Abstract
Knees are the most commonly impacted weight-bearing joints in osteoarthritis (OA), affecting millions of people worldwide. With increasing life spans and obesity rates, the incidence of knee OA will further increase, leading to a significant increase in the economic burden. Conventional treatment modalities utilized to manage knee OA have limitations. Over the last decade, the role of various autologous peripheral blood-derived orthobiologics (APBOs) for the treatment of knee OA has been extensively investigated. This editorial provided an overview and focused on defining and shedding light on the current state of evidence based on the most recent published clinical studies concerning the use of APBO for the management of knee OA. While numerous studies have demonstrated promising results for these preparations, a notable gap exists in the comparative analysis of these diverse formulations. This absence of head-to-head studies poses a considerable challenge for physicians/surgeons in determining the optimal preparation for managing knee OA and achieving sustained long-term results. Thus, more adequately powered, multicenter, prospective, double-blind, randomized controlled trials with longer follow-ups are needed to establish the long-term efficacy and to aid physicians/surgeons in determining the optimal APBO for the management of knee OA.
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Affiliation(s)
- Ashim Gupta
- Department of Orthopaedics and Regenerative Medicine, Future Biologics, Lawrenceville, GA 30043, United States
- Department of Orthopaedics, South Texas Orthopaedic Research Institute (STORI Inc.), Laredo, TX 78045, United States
- Department of Regenerative Medicine, BioIntegrate, Lawrenceville, GA 30043, United States
- Department of Orthopaedics and Regenerative Medicine, Regenerative Orthopaedics, Noida 201301, India
| | - Vijay Kumar Jain
- Department of Orthopaedics, Atal Bihari Vajpayee Institute of Medical Sciences, Dr. Ram Manohar Lohia Hospital, Delhi 110001, New Delhi, India
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Migliorini F, Pilone M, Schäfer L, Simeone F, Bell A, Maffulli N. Functional alignment in robotic-assisted total knee arthroplasty: a systematic review. Arch Orthop Trauma Surg 2024; 144:1741-1749. [PMID: 38337093 DOI: 10.1007/s00402-023-05195-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/02/2023] [Accepted: 12/21/2023] [Indexed: 02/12/2024]
Abstract
PURPOSE The present study systematically reviewed current evidence on functional alignment (FA) in robotic total knee arthroplasty (TKA), discussing advantages and limitations, possible pitfalls, and prospects. METHODS This study was conducted according to the 2020 PRISMA statement. In August 2023, the following databases were accessed: PubMed, Web of Science, Google Scholar, and Embase with no additional filters or time constraints. All the clinical studies investigating functional alignment in robotic TKA were accessed. Only studies published in peer-reviewed journals were considered. The risk of bias was evaluated following the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions. Non-randomized controlled trials (non-RCTs) were evaluated using the Risk of Bias in Nonrandomised Studies of Interventions (NRSI) (ROBINS-I) tool. RESULTS Data from 1198 patients (seven studies) were retrieved. The mean length of the follow-up was 17.1 ± 6.4 months. The mean age was 67.2 ± 5.4 years, and the mean BMI was 30.9 ± 2.7 kg/m2. CONCLUSION FA might improve resection accuracy, implant alignment, and gap balancing in TKA, and additional high-quality clinical trials are necessary to properly establish the superiority of FA to other alignment techniques in TKA. Long-term clinical trials are needed to investigate the impact of FA on implant survivorship. LEVEL OF EVIDENCE Level IV, systematic review and meta-analysis.
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Affiliation(s)
- Filippo Migliorini
- Department of Orthopaedic, Trauma, and Reconstructive Surgery, RWTH University Medical Centre, Pauwelsstraße 30, 52074, Aachen, Germany.
- Department of Orthopedics and Trauma Surgery, Academic Hospital of Bolzano (SABES-ASDAA), Teaching Hospital of the Paracelsus Medical University, 39100, Bolzano, Italy.
| | - Marco Pilone
- Residency Program in Orthopedics and Traumatology, University of Milan, Milan, Italy
| | - Luise Schäfer
- Department of Orthopaedic, Trauma, and Reconstructive Surgery, RWTH University Medical Centre, Pauwelsstraße 30, 52074, Aachen, Germany
| | - Francesco Simeone
- Department of Orthopedics and Trauma Surgery, Academic Hospital of Bolzano (SABES-ASDAA), Teaching Hospital of the Paracelsus Medical University, 39100, Bolzano, Italy
| | - Andreas Bell
- Department of Orthopedics, Eifelklinik St. Brigida, Simmerath, Germany
| | - Nicola Maffulli
- Department of Medicine and Psychology, University of Rome "La Sapienza", Rome, Italy
- School of Pharmacy and Bioengineering, Faculty of Medicine, Keele University, Stoke On Trent, ST4 7QB, UK
- Centre for Sports and Exercise Medicine, Barts and the London School of Medicine and Dentistry, Mile End Hospital, Queen Mary University of London, London, E1 4DG, UK
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Migliorini F, Feierabend M, Hofmann UK. Fostering Excellence in Knee Arthroplasty: Developing Optimal Patient Care Pathways and Inspiring Knowledge Transfer of Advanced Surgical Techniques. J Healthc Leadersh 2023; 15:327-338. [PMID: 38020721 PMCID: PMC10676205 DOI: 10.2147/jhl.s383916] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2023] [Accepted: 11/13/2023] [Indexed: 12/01/2023] Open
Abstract
Osteoarthritis of the knee is common. Early sports trauma or cartilage defects are risk factors for osteoarthritis. If conservative treatment fails, partial or total joint replacement is often performed. A joint replacement aims to restore physiological biomechanics and the quality of life of affected patients. Total knee arthroplasty is one of the most performed surgeries in musculoskeletal medicine. Several developments have taken place over the last decades that have truly altered the way we look at knee arthroplasty today. Some of the fascinating aspects will be presented and discussed in the present narrative review.
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Affiliation(s)
- Filippo Migliorini
- Department of Orthopaedic, Trauma, and Reconstructive Surgery, RWTH University Medical Centre, Aachen, 52074, Germany
- Department of Orthopedics and Trauma Surgery, Academic Hospital of Bolzano (SABES-ASDAA), Teaching Hospital of Paracelsus Medical University, 39100 Bolzano, Italy
| | - Martina Feierabend
- Department of Orthopaedic, Trauma, and Reconstructive Surgery, RWTH University Medical Centre, Aachen, 52074, Germany
| | - Ulf Krister Hofmann
- Department of Orthopaedic, Trauma, and Reconstructive Surgery, RWTH University Medical Centre, Aachen, 52074, Germany
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