Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis
Introduction Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical...
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BMJ Publishing Group
2020-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/3/e031864.full |
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| author | Ewa M Roos Martin Englund Victor A van de Graaf Rudolf W Poolman Maroeska M Rovers Stan R W Wijn Jan J Rongen Håvard Østerås May A Risberg Kristoffer B Hare Gerjon Hannink |
| author_facet | Ewa M Roos Martin Englund Victor A van de Graaf Rudolf W Poolman Maroeska M Rovers Stan R W Wijn Jan J Rongen Håvard Østerås May A Risberg Kristoffer B Hare Gerjon Hannink |
| author_sort | Ewa M Roos |
| collection | DOAJ |
| description | Introduction Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment.Methods and analysis An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs’ characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health.Ethics and dissemination All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal.PROSPERO registration number CRD42017067240. |
| format | Article |
| id | doaj-art-9ebc66a5b45e4f5b823dc0980fa6b52a |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-9ebc66a5b45e4f5b823dc0980fa6b52a2025-08-20T01:59:30ZengBMJ Publishing GroupBMJ Open2044-60552020-03-0110310.1136/bmjopen-2019-031864Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysisEwa M Roos0Martin Englund1Victor A van de Graaf2Rudolf W Poolman3Maroeska M Rovers4Stan R W Wijn5Jan J Rongen6Håvard Østerås7May A Risberg8Kristoffer B Hare9Gerjon Hannink10Department of Sports and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy and Center for Muscle and Joint Health, University of Southern Denmark, Odense, DenmarkClinical Epidemiology Unit, Orthopaedics, Lund University, Lund, SwedenDepartment of Orthopaedic Surgery, University Medical Centre Utrecht, Utrecht, The NetherlandsDepartment of Orthopaedic Surgery, Joint Research, OLVG, 1090 HM Amsterdam, The NetherlandsOperation Rooms, Health Evidence, Radboudumc, Nijmegen, The NetherlandsDepartment of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The NetherlandsDepartment of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The NetherlandsDepartment of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, NorwayDepartment of Sport Medicine, Norwegian School of Sport Sciences, Oslo University Hospital, Oslo, NorwayDepartment of Orthopedics, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, DenmarkOperating Rooms, Radboud Institute of Health Sciences, Radboudumc, Nijmegen, The NetherlandsIntroduction Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment.Methods and analysis An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs’ characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health.Ethics and dissemination All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal.PROSPERO registration number CRD42017067240.https://bmjopen.bmj.com/content/10/3/e031864.full |
| spellingShingle | Ewa M Roos Martin Englund Victor A van de Graaf Rudolf W Poolman Maroeska M Rovers Stan R W Wijn Jan J Rongen Håvard Østerås May A Risberg Kristoffer B Hare Gerjon Hannink Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis BMJ Open |
| title | Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis |
| title_full | Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis |
| title_fullStr | Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis |
| title_full_unstemmed | Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis |
| title_short | Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis |
| title_sort | arthroscopic meniscectomy versus non surgical or sham treatment in patients with mri confirmed degenerative meniscus lesions a protocol for an individual participant data meta analysis |
| url | https://bmjopen.bmj.com/content/10/3/e031864.full |
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