Better outcome from arthroscopic partial meniscectomy than skin incisions only? A sham-controlled randomised trial in patients aged 35-55 years with knee pain and an MRI-verified meniscal tear

Ewa M Roos, Kristoffer Borbjerg Hare, Sabrina Mai Nielsen, Robin Christensen, L Stefan Lohmander, Ewa M Roos, Kristoffer Borbjerg Hare, Sabrina Mai Nielsen, Robin Christensen, L Stefan Lohmander

Abstract

Objective: Compare arthroscopic partial meniscectomy to a true sham intervention.

Methods: Sham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35-55 years with persistent knee pain and an MRI-confirmed medial meniscus lesion. A computer-generated table of random numbers generated two comparison groups. Participants and outcome assessors were blinded to group allocation. Exclusions were locking knees, high-energy trauma or severe osteoarthritis. Outcomes were collected at baseline, 3 and 24 months. We hypothesised no difference between groups. The primary outcome was the between-group difference in change from baseline to 2 years in the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS5).

Results: Forty-four patients (of the estimated 72) underwent randomisation; 22 in each group. Sixteen participants (36%) were non-blinded and eight participants (36%) from the sham group crossed over to the surgery group prior to the 2-year follow-up. At 2 years, both groups reported clinically relevant improvements (surgery 21.8, skin incisions only 13.6), the mean difference between groups was 8.2 in favour of surgery, which is slightly less than the cut-off of 10 prespecified to represent a clinically relevant difference; judged by the 95% CI (-3.4 to 19.8), a possibility of clinically relevant difference could not be excluded. In total, nine participants experienced 11 adverse events; six in the surgery group and three in the skin-incisions-only group.

Conclusion: We found greater improvement from arthroscopic partial meniscectomy compared with skin incisions only at 2 years, with the statistical uncertainty of the between-group difference including what could be considered clinically relevant. Because of the study being underpowered, nearly half in the sham group being non-blinded and one-third crossing over to surgery, the results cannot be generalised to the greater patient population.

Trial registration number: NCT01264991.

Keywords: adult orthopaedics; knee; musculoskeletal disorders; orthopaedic sports trauma.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study flow.
Figure 2
Figure 2
Least square mean for each group over time for the primary outcome (KOOS5) for intention-to-treat (A) and per-protocol (B) analyses. Solid lines represent the arthroscopic partial meniscectomy group and stipled lines the skin incision only group. KOOS5, the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score subscales.
Figure 3
Figure 3
Forest plot illustrating the contrast between the treatment arms after 2 years for intention-to-treat (A) and per-protocol (B) groups. ADL, Function, daily living; KOOS, Knee injury and Osteoarthritis Outcome Score; KOOS5, the mean score across all five normalised KOOS subscales; MCS, Mental Component Score; PCS, Physical Component Score; QOL, quality of life; SF-36. Short-Form 36 items.

References

    1. Cross M, Smith E, Hoy D, et al. . The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis 2014;73:1323–30. 10.1136/annrheumdis-2013-204763
    1. McAlindon TE, Bannuru RR, Sullivan MC, et al. . OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage 2014;22:363–88. 10.1016/j.joca.2014.01.003
    1. Hochberg MC, Altman RD, April KT, et al. . American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res 2012;64:465–74. 10.1002/acr.21596
    1. Fernandes L, Hagen KB, Bijlsma JW, et al. . EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis 2013;72:1125–35. 10.1136/annrheumdis-2012-202745
    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. Monk P, Garfjeld Roberts P, Palmer AJ, et al. . The Urgent Need for Evidence in Arthroscopic Meniscal Surgery: A Systematic Review of the Evidence for Operative Management of Meniscal Tears. Am J Sports Med 2016.
    1. Yim JH, Seon JK, Song EK, et al. . A comparative study of meniscectomy and nonoperative treatment for degenerative horizontal tears of the medial meniscus. Am J Sports Med 2013;41:1565–70. 10.1177/0363546513488518
    1. Sihvonen R, Paavola M, Malmivaara A, et al. . Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med 2013;369:2515–24. 10.1056/NEJMoa1305189
    1. Kise NJ, Risberg MA, Stensrud S, et al. . Exercise therapy versus arthroscopic partial menisectomy; Effect on mechanical symptoms. The 13th Scandinavian Congress of Medicine and Science in Sports. Norefjell, Norway 2016.
    1. Lattermann C, Gomoll AH, Cole BJ. Arthroscopic partial meniscectomy for degenerative meniscal tear. N Engl J Med 2014;370:1260 10.1056/NEJMc1401128#SA3
    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. Holmes R, Moschetti W, Martin B, et al. . Effect of evidence and changes in reimbursement on the rate of arthroscopy for osteoarthritis. Am J Sports Med 2013;41:1039–43. 10.1177/0363546513479771
    1. Moseley JB, O’Malley K, Petersen NJ, et al. . A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002;347:81–8. 10.1056/NEJMoa013259
    1. Zou K, Wong J, Abdullah N, et al. . Examination of overall treatment effect and the proportion attributable to contextual effect in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis 2016;75:1964–70. 10.1136/annrheumdis-2015-208387
    1. Wartolowska K, Judge A, Hopewell S, et al. . Use of placebo controls in the evaluation of surgery: systematic review. BMJ 2014;348:g3253 10.1136/bmj.g3253
    1. Jonas WB, Crawford C, Colloca L, et al. . To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials. BMJ Open 2015;5:e009655 10.1136/bmjopen-2015-009655
    1. Hare KB, Lohmander LS, Christensen R, et al. . Arthroscopic partial meniscectomy in middle-aged patients with mild or no knee osteoarthritis: a protocol for a double-blind, randomized sham-controlled multi-centre trial. BMC Musculoskelet Disord 2013;14:71 10.1186/1471-2474-14-71
    1. Roos EM, Roos HP, Ekdahl C, et al. . Knee injury and Osteoarthritis Outcome Score (KOOS)-validation of a Swedish version. Scand J Med Sci Sports 1998;8:439–48. 10.1111/j.1600-0838.1998.tb00465.x
    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. Kroman SL, Roos EM, Bennell KL, et al. . Measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis: a systematic review. Osteoarthritis Cartilage 2014;22:26–39. 10.1016/j.joca.2013.10.021
    1. Bremander AB, Dahl LL, Roos EM. Validity and reliability of functional performance tests in meniscectomized patients with or without knee osteoarthritis. Scand J Med Sci Sports 2007;17:120–7. 10.1111/j.1600-0838.2006.00544.x
    1. Ranstam J, Turkiewicz A, Boonen S, et al. . Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE). BMC Med Res Methodol 2012;12:35 10.1186/1471-2288-12-35
    1. Hare KB, Lohmander LS, Roos EM. The challenge of recruiting patients into a placebo-controlled surgical trial. Trials 2014;15:167 10.1186/1745-6215-15-167
    1. Feys F, Bekkering GE, Singh K, et al. . Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? Syst Rev 2014;3:14 10.1186/2046-4053-3-14

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