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Surgery
Protocol
Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults
  1. Søren Thorgaard Skou1,2,
  2. Martin Lind3,
  3. Per Hölmich4,
  4. Hans Peter Jensen5,
  5. Carsten Jensen6,7,
  6. Muhammad Afzal8,
  7. Uffe Jørgensen9,
  8. Jonas Bloch Thorlund1
  1. 1 Department of Sports Science and Clinical Biomechanics, Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark, Odense, Denmark
  2. 2 Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Slagelse, Denmark
  3. 3 Department of Sports Traumatology, Aarhus University Hospital, Aarhus, Denmark
  4. 4 Department of Orthopaedic Surgery, Sports Orthopedic Research Center–Copenhagen (SORC-C), Copenhagen University Hospital, Copenhagen, Denmark
  5. 5 Department of Orthopaedic Surgery, Aalborg University Hospital, Aalborg, Denmark
  6. 6 Department of Orthopaedic Surgery, Lillebælt Hospital in Kolding, Kolding, Denmark
  7. 7 Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
  8. 8 Department of Orthopaedic Surgery, Næstved Hospital, Næstved, Denmark
  9. 9 Department of Orthopaedics and Traumatology, Odense University Hospital, Odense, Denmark
  1. Correspondence to Dr Søren Thorgaard Skou; stskou{at}health.sdu.dk

Abstract

Introduction Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears.

Methods and analysis This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18–40 years with a clinical history and symptoms consistent with a meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon will be randomly allocated to one of two groups (1:1 ratio). Participants randomised to surgery will undergo either arthroscopic partial meniscectomy or meniscal repair followed by standard postsurgical care, while participants allocated to exercise and education will undergo a 12-week individualised, supervised neuromuscular and strengthening exercise programme and patient education. The primary outcome will be difference in change from baseline to 12 months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, function in sports and recreation and quality of life (Knee Injury and Osteoarthritis Outcome Score (KOOS4)) supported by the individual subscale scores allowing clinical interpretation. Alongside, the RCT an observational cohort will follow patients aged 18–40 years with clinical suspicion of a meniscal tear, but not fully eligible or declining to participate in the trial.

Ethics and dissemination Results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Regional Committees on Health Research Ethics for Southern Denmark.

Registration details ClinicalTrials.gov (NCT02995551).

  • clinical trials
  • rehabilitation medicine
  • sports medicine
  • musculoskeletal disorders

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017436

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    Footnotes

    • Twitter Follow Søren T. Skou at @STSkou and Jonas B. Thorlund at @jbthorlund.

    • Contributors STS and JBT conceived the trial and led the development of all procedures including intervention design (exercise intervention and patient education), data management and statistical analyses and drafted the first version of the manuscript. ML, PH, HPJ, CJ, MA and UJ provided feedback on the study, led setup of procedures and data collection at the recruiting hospitals. All authors provided critical intellectual input to the manuscript and read and approved the final version of the manuscript, agreeing to be accountable for all aspects of the work.

    • Funding The study is funded by the Danish Council for Independent Research (DFF–6110-00045), IMK Almene Fond, The Lundbeck Foundation, the Spar Nord Foundation, the Danish Rheumatism Association, The Association of Danish Physiotherapists Research Fund and The Research council at Næstved-Slagelse-Ringsted Hospitals. The funders have no role in the design of the study and will not have any role in its execution, data management, analysis and interpretation or on the decision to submit results for publication.

    • Competing interests STS is one of the founders of Good Life with osteoarthritis in Denmark (GLA:D), which is a non-profit initiative hosted at University of Southern Denmark. STS is Associate Editor for Journal of Orthopaedic and Sports Physical Therapy. The authors affirm that they have no other competing interests.

    • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

    • Ethics approval The Regional Committees on Health Research Ethics for Southern Denmark.

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