Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults

Søren Thorgaard Skou, Martin Lind, Per Hölmich, Hans Peter Jensen, Carsten Jensen, Muhammad Afzal, Uffe Jørgensen, Jonas Bloch Thorlund, Søren Thorgaard Skou, Martin Lind, Per Hölmich, Hans Peter Jensen, Carsten Jensen, Muhammad Afzal, Uffe Jørgensen, Jonas Bloch Thorlund

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).

Keywords: clinical trials; musculoskeletal disorders; rehabilitation medicine; sports medicine.

Conflict of interest statement

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.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Patient flow through the study. RCT, randomised controlled trial; KOOS4, the mean score for the Knee Injury and Osteoarthritis Outcome Score subscales pain, symptoms, function in sports and recreational activities (Sport/Rec) and quality of life (QOL).

References

    1. Lim HC, Adie S, Naylor JM, et al. . Randomised trial support for orthopaedic surgical procedures. PLoS One 2014;9:e96745 10.1371/journal.pone.0096745
    1. van Adrichem RA, Nemeth B, Algra A, et al. . Thromboprophylaxis after knee arthroscopy and lower-leg casting. N Engl J Med 2017;376:515–25. 10.1056/NEJMoa1613303
    1. Kim S, Bosque J, Meehan JP, et al. . Increase in outpatient knee arthroscopy in the United States: a comparison of National surveys of ambulatory surgery, 1996 and 2006. J Bone Joint Surg Am 2011;93:994–1000. 10.2106/JBJS.I.01618
    1. Price A, Beard D. Arthroscopy for degenerate meniscal tears of the knee. BMJ 2014;348:g2382 10.1136/bmj.g2382
    1. Thorlund JB, Juhl CB, Roos EM, et al. . Arthroscopic surgery for degenerative knee: systematic review and meta-analysis of benefits and harms. BMJ 2015;350:h2747 10.1136/bmj.h2747
    1. Khan M, Evaniew N, Bedi A, et al. . Arthroscopic surgery for degenerative tears of the meniscus: a systematic review and meta-analysis. CMAJ 2014;186:1057–64. 10.1503/cmaj.140433
    1. Kise NJ, Risberg MA, Stensrud S, et al. . Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up. BMJ 2016;354:i3740.
    1. Thorlund JB, Østengaard L, Cardy N, et al. . Trajectory of self-reported pain and function and knee extensor muscle strength in young patients undergoing arthroscopic surgery for meniscal tears: a systematic review and meta-analysis. J Sci Med Sport 2017;20:712–7. 10.1016/j.jsams.2017.02.004
    1. Buchbinder R, Harris IA, Sprowson A. Management of degenerative meniscal tears and the role of surgery. BMJ 2015;350:h2212.
    1. Frobell RB, Roos EM, Roos HP, et al. . A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med 2010;363:331–42. 10.1056/NEJMoa0907797
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586 10.1136/bmj.e7586
    1. Moher D, Hopewell S, Schulz KF, et al. . CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869 10.1136/bmj.c869
    1. Järvinen TL, Sihvonen R, Bhandari M, et al. . Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol 2014;67:769–72. 10.1016/j.jclinepi.2013.11.011
    1. Skou ST, Roos EM, Laursen MB, et al. . A randomized, controlled trial of total knee replacement. N Engl J Med 2015;373:1597–606. 10.1056/NEJMoa1505467
    1. Ageberg E, Roos EM. Neuromuscular exercise as treatment of degenerative knee disease. Exerc Sport Sci Rev 2015;43:14–22. 10.1249/JES.0000000000000030
    1. Skou ST, Rasmussen S, Laursen MB, et al. . The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthritis Cartilage 2015;23:1465–75. 10.1016/j.joca.2015.04.021
    1. Skou ST, Roos EM. Good life with osteoArthritis in Denmark (GLA:D™): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord 2017;18:72 10.1186/s12891-017-1439-y
    1. Skou ST, Thorlund JB. A 12-week supervised exercise therapy program for young adults with a meniscal tear: Program development and feasibility study. J Bodyw Mov Ther 2017. 10.1016/j.jbmt.2017.07.010
    1. Slade SC, Dionne CE, Underwood M, et al. . Consensus on Exercise Reporting Template (CERT): explanation and elaboration statement. Br J Sports Med 2016;50:1428–37. 10.1136/bjsports-2016-096651
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: Template for Intervention Description and Replication (TIDieR) checklist and guide. BMJ 2014;348:g1687 10.1136/bmj.g1687
    1. Weinstein JN, Tosteson TD, Lurie JD, et al. . Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 2006;296:2441–50. 10.1001/jama.296.20.2441
    1. Sandal LF, Roos EM, Bøgesvang SJ, et al. . Pain trajectory and exercise-induced pain flares during 8 weeks of neuromuscular exercise in individuals with knee and hip pain. Osteoarthritis Cartilage 2016;24:589–92. 10.1016/j.joca.2015.11.002
    1. Collins NJ, Prinsen CA, Christensen R, et al. . Knee Injury and Osteoarthritis Outcome score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage 2016;24:1317–29. 10.1016/j.joca.2016.03.010
    1. Roos EM, Roos HP, Lohmander LS, et al. . Knee Injury and Osteoarthritis Outcome score (KOOS) – development of a self-administered outcome measure. J Orthop Sports Phys Ther 1998;28:88–96. 10.2519/jospt.1998.28.2.88
    1. Thorlund JB, Englund M, Christensen R, et al. . Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears: comparative prospective cohort study. BMJ 2017;356:j356 10.1136/bmj.j356
    1. Kirkley A, Griffin S, Whelan D. The development and validation of a quality of life-measurement tool for patients with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clin J Sport Med 2007;17:349–56. 10.1097/JSM.0b013e31814c3e15
    1. Sihvonen R, Järvelä T, Aho H, et al. . Validation of the Western Ontario Meniscal Evaluation Tool (WOMET) for patients with a degenerative meniscal tear: a meniscal pathology-specific quality-of-life index. J Bone Joint Surg Am 2012;94:e65 10.2106/JBJS.K.00804
    1. Gronbech Jorgensen M, Andersen S, Ryg J, et al. . Novel use of the Nintendo Wii board for measuring isometric lower limb strength: a reproducible and valid method in older adults. PLoS One 2015;10:e0138660 10.1371/journal.pone.0138660
    1. U. S. Food Drug Administration. What is a serious adverse event? Silver Spring, MD: FDA, 2014. (accessed 15 Feb 2017).
    1. Conner-Spady BL, Marshall DA, Bohm E, et al. . Reliability and validity of the EQ-5D-5L compared to the EQ-5D-3L in patients with osteoarthritis referred for hip and knee replacement. Qual Life Res 2015;24:1775–84. 10.1007/s11136-014-0910-6
    1. Janssen MF, Pickard AS, Golicki D, et al. . Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res 2013;22:1717–27. 10.1007/s11136-012-0322-4
    1. Saltin B, Grimby G. Physiological analysis of middle-aged and old former athletes. Comparison with still active athletes of the same ages. Circulation 1968;38:1104–15. 10.1161/01.CIR.38.6.1104
    1. Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res 1985;198:42–9. 10.1097/00003086-198509000-00007
    1. Tubach F, Ravaud P, Baron G, et al. . Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis 2005;64:34–7. 10.1136/ard.2004.023028
    1. Ingelsrud LH, Granan LP, Terwee CB, et al. . Proportion of patients reporting acceptable symptoms or treatment failure and their associated KOOS values at 6 to 24 months after anterior cruciate ligament reconstruction: a study from the Norwegian knee ligament registry. Am J Sports Med 2015;43:1902–7. 10.1177/0363546515584041
    1. Hawker GA, Mian S, Kendzerska T, et al. . Measures of adult pain: visual analog scale for pain (VAS Pain), numeric rating scale for pain (NRS pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short form-36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP). Arthritis Care Res 2011;63(S11):S240–S252. 10.1002/acr.20543
    1. Anderson AF, Irrgang JJ, Dunn W, et al. . Interobserver reliability of the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) classification of meniscal tears. Am J Sports Med 2011;39:926–32. 10.1177/0363546511400533
    1. Brittberg M, Winalski CS. Evaluation of cartilage injuries and repair. J Bone Joint Surg Am 2003;85-A Suppl 2(-A Suppl 2):58–69. 10.2106/00004623-200300002-00008
    1. Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 2003;1:64 10.1186/1477-7525-1-64
    1. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol 2004;159:702–6. 10.1093/aje/kwh090

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