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Open Access Study protocol

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

Kristoffer B Hare1*, L Stefan Lohmander123, Robin Christensen14 and Ewa M Roos1

Author Affiliations

1 Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark

2 Department of Orthopedics, Clinical Sciences Lund, University of Lund, Lund, Sweden

3 Department of Orthopedics and Traumatology, University of Southern Denmark, Odense, Denmark

4 Musculoskeletal Statistics Unit, the Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Frederiksberg, Copenhagen, Denmark

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BMC Musculoskeletal Disorders 2013, 14:71  doi:10.1186/1471-2474-14-71

Published: 25 February 2013

Abstract

Background

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 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.

Methods

We 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.

Discussion

Demonstration 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 registration

NCT01264991