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.

Ewa M Roos,Robin Christensen,L Stefan Lohmander,Kristoffer B Hare

doi:10.1186/1471-2474-14-71

Abstract

BackgroundArthroscopic partial meniscectomy has been shown to be of no benefit to patients with concomitant knee osteoarthritis, but the optimal treatment of a degenerative meniscus tear in patients with mild or no knee osteoarthritis is unknown. This article describes the rationale and methodology of a randomized sham-controlled trial to assess the benefit of arthroscopic partial meniscectomy of a medial meniscus tear in patients with mild or no knee osteoarthritis. The objective of the study is to test whether the benefit from arthroscopic partial meniscectomy in patients with knee pain, medial meniscus lesion and mild/no knee osteoarthritis, is greater after arthroscopic partial meniscectomy than following sham surgery.MethodsWe will conduct a randomized controlled trial of treatment for degenerative meniscus tears in middle-aged patients (aged 35–55 years) with an MRI-verified medial meniscus lesion and mild or no knee radiographic osteoarthritis (grade 0–2 on the Kellgren & Lawrence scale). Patients will be randomized to receive either conventional arthroscopic partial meniscectomy or a sham surgery procedure. The primary outcome will be the KOOS5 derived from the ‘Knee Injury and Osteoarthritis Outcome Score’ at 2 years follow-up. Secondary outcomes at 2 years will include all five individual subscales of the KOOS, a global perceived effect score, the Short-Form-36 health status score, EQ-5D for economic appraisal and objective tests of muscle strength and physical function. Radiographic knee osteoarthritis will be evaluated at 5 years.DiscussionDemonstration of no additional benefit from arthroscopic partial meniscectomy on pain and function should lead to a change in clinical care of patients with a degenerative meniscus tear. The results of this study will provide empirical evidence for the potential benefit/harm of arthroscopic partial meniscectomy compared to a masked sham-therapeutics intervention.Trial registrationNCT01264991

Highlights

Arthroscopic partial meniscectomy has been shown to be of no benefit to patients with concomitant knee osteoarthritis, but the optimal treatment of a degenerative meniscus tear in patients with mild or no knee osteoarthritis is unknown
Arthroscopic partial meniscectomy is the current treatment of choice in patients with mild or no concomitant knee osteoarthritis but this has not been formally evaluated in randomized placebo controlled trials
The outcome of this study will show whether arthroscopic partial meniscectomy is a viable treatment modality

Summary

Introduction

Arthroscopic partial meniscectomy has been shown to be of no benefit to patients with concomitant knee osteoarthritis, but the optimal treatment of a degenerative meniscus tear in patients with mild or no knee osteoarthritis is unknown. This article describes the rationale and methodology of a randomized sham-controlled trial to assess the benefit of arthroscopic partial meniscectomy of a medial meniscus tear in patients with mild or no knee osteoarthritis. The current standard treatment for a degenerative meniscus tear is arthroscopic partial meniscectomy (APM), the most commonly performed orthopedic procedure, carried out on 1 million patients annually in the USA [2]. Both meniscus injury and a meniscectomy are. The benefits of the APM procedure on pain and function in patients with a degenerative meniscus tear, were firstly described in non-controlled studies from the 1980s to the 1990s [9,10,11] when arthroscopic procedures were gaining acceptance. At the time of this submission, there are, to our knowledge, no published high quality controlled, randomized studies that show a benefit from APM as compared to other treatment modalities (placebo, physiotherapy, medication or exercise) on pain and function in patients aged 35–55 years with a degenerative medial meniscus tear

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