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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

Wijn, Stan R.W. ; Rovers, Maroeska M. ; Rongen, Jan J. ; Østerås, Håvard ; Risberg, May A. ; Roos, Ewa M. LU ; Hare, Kristoffer B. ; Van De Graaf, Victor A. ; Poolman, Rudolf W. and Englund, Martin LU , et al. (2020) In BMJ Open 10(3).
Abstract

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... (More)

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. 

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publishing date
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publication status
published
subject
keywords
arthroscopic surgery, individual participant data meta-analysis, IPDMA, meniscectomy, osteoarthritis
in
BMJ Open
volume
10
issue
3
article number
e031864
publisher
British Medical Journal Publishing Group
external identifiers
  • scopus:85081621987
  • pmid:32152157
ISSN
2044-6055
DOI
10.1136/bmjopen-2019-031864
language
English
LU publication?
yes
id
490e97e6-a01a-416d-928e-a902bfe076eb
date added to LUP
2020-04-01 15:03:52
date last changed
2020-04-02 03:00:01
@article{490e97e6-a01a-416d-928e-a902bfe076eb,
  abstract     = {<p>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. </p>},
  author       = {Wijn, Stan R.W. and Rovers, Maroeska M. and Rongen, Jan J. and Østerås, Håvard and Risberg, May A. and Roos, Ewa M. and Hare, Kristoffer B. and Van De Graaf, Victor A. and Poolman, Rudolf W. and Englund, Martin and Hannink, Gerjon},
  issn         = {2044-6055},
  language     = {eng},
  month        = {03},
  number       = {3},
  publisher    = {British Medical Journal Publishing Group},
  series       = {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},
  url          = {http://dx.doi.org/10.1136/bmjopen-2019-031864},
  doi          = {10.1136/bmjopen-2019-031864},
  volume       = {10},
  year         = {2020},
}