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Protocol
Effects of mechanical interventions in the management of knee osteoarthritis: protocol for an OA Trial Bank systematic review and individual participant data meta-analysis
  1. Erin M Macri1,2,
  2. Michael Callaghan3,
  3. Marienke van Middelkoop2,
  4. Miriam Hattle4,
  5. Sita M A Bierma-Zeinstra1,2
  1. 1 Department of Orthopaedics and Sports Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands
  2. 2 Department of General Practice, Erasmus University Medical Center, Rotterdam, The Netherlands
  3. 3 Department of Health Professions, Manchester Metropolitan University, Manchester, UK
  4. 4 School of Primary, Community and Social Care, Keele University, Keele, UK
  1. Correspondence to Dr Erin M Macri; e.macri{at}erasmusmc.nl

Abstract

Introduction Knee osteoarthritis (OA) is a prevalent and disabling musculoskeletal condition. Biomechanical factors may play a key role in the aetiology of knee OA, therefore, a broad class of interventions involves the application or wear of devices designed to mechanically support knees with OA. These include gait aids, bracing, taping, orthotics and footwear. The literature regarding efficacy of mechanical interventions has been conflicting or inconclusive, and this may be because certain subgroups with knee OA respond better to mechanical interventions. Our primary aim is to identify subgroups with knee OA who respond favourably to mechanical interventions.

Methods and analysis We will conduct a systematic review to identify randomised clinical trials of any mechanical intervention for the treatment of knee OA. We will invite lead authors of eligible studies to share individual participant data (IPD). We will perform an IPD meta-analysis for each type of mechanical intervention to evaluate efficacy, with our main outcome being pain. Where IPD are not available, this will be achieved using aggregate data. We will then evaluate five potential treatment effect modifiers using a two-stage approach. If data permit, we will also evaluate whether biomechanics mediate the effects of mechanical interventions on pain in knee OA.

Ethics and dissemination No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publication in peer-reviewed journals and summaries posted on websites serving the public and clinicians.

PROSPERO registration number CRD42020155466.

  • knee
  • rheumatology
  • rehabilitation medicine
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Footnotes

  • Twitter @erin_macri

  • Contributors The study was conceptualised by EMM, MvM and SMAB-Z. MvM and SMAB-Z provided specific guidance regarding OA Trial Bank procedures. Study design and methodology was performed by EMM, MC, MvM, MH, and SMAB-Z. Statistical expertise was provided by MH. EMM led the draft of the manuscript, and MC, MvM, MH, and SMAB-Z all provided substantial intellectually input to the manuscript. All authors approved the final manuscript.

  • Funding EMM was funded by a Canadian Institutes of Health Research (CIHR) Banting Postdoctoral Fellowship. The OA Trial Bank has received funding from ReumaNederland (grant number CIO-01).

  • Competing interests SMAB-Z reports grants from The Netherlands Organisation for Health Research and Development, CZ, European Union, Foreum, Dutch Arthritis Association, personal fees from Osteoarthritis Research Society International (OARSI), personal fees from Infirst Healthcare, and personal fees from Pfizer, all outside of the submitted work. We have no other disclosures.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.