Objective To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus.
Methods In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35–65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out.
Results In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, −4.3; 95% CI, −11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (−3.2; −8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (−0.4; −1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups.
Conclusions In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.
- knee osteoarthritis
- orthopaedic surgery
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Contributors The Finnish Degenerative Meniscal Lesion Study (FIDELITY) trial (patient enrolment and execution of follow-up assessments in 2007–2015) is carried out by the FIDELITY Investigators. Conception and design: RS, MP, AM and TLNJ. Analysis and interpretation of the data: RS and TLNJ. Drafting of the article: RS and TLNJ. Critical revision of the article for important intellectual content and final approval: all authors. Ensuring the accuracy of the work: RS and TLNJ. Obtaining of funding: TLNJ. All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.
Funding This study was supported by the Jane and Aatos Erkko Foundation, the Sigrid Juselius Foundation, the State funding for university-level health research (Tampere and Helsinki University Hospitals), the Social Insurance Institution of Finland (KELA) and the Academy of Finland. Dr Sihvonen is supported also by The Finnish Medical Foundation and Orion-Pharmos Research Foundation. The funding sources had no role in in the collection, analysis and interpretation of data; in the writing of the report and in the decision to submit the article for publication.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Given that the informed consent forms of the Finnish Degenerative Meniscal Lesion Study trial did not include a provision for data sharing (trial launched in 2007), the full dataset cannot be shared due to a potential breach of the Finnish Personal Data Act. Scientists with a specific question regarding the trial data are encouraged to contact the corresponding author (TLNJ).
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