Abstract

PurposePartial meniscectomy is a common orthopedic procedure intended to improve knee pain and function in patients with irreparable meniscal tears. However, 6–25% of partial meniscectomy patients experience persistent knee pain after surgery. In this randomized controlled trial (RCT) involving subjects with knee pain following partial meniscectomy, it was hypothesized that treatment with a synthetic medial meniscus replacement (MMR) implant provides significantly greater improvements in knee pain and function compared to non-surgical care alone.MethodsIn this prospective, multicenter RCT, subjects with persistent knee pain following one or more previous partial meniscectomies were randomized to receive either MMR or non-surgical care. This analysis evaluated the 1-year outcomes of this 2-year clinical trial. Patient-reported knee pain, function, and quality of life were measured using nine separate patient-reported outcomes. The primary outcomes were the pain subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) and the average of all five KOOS subscales (KOOS Overall). Treatment cessation was defined as permanent device removal in the MMR group and any surgical procedure to the index knee in the non-surgical care group.ResultsTreated subjects had a median age of 52 years old (range 30–69 years) and one or more previous partial meniscectomies at a median of 34 months (range 5–430 months) before trial entry. Among 127 subjects treated with either MMR (n = 61) or non-surgical care (n = 66), 11 withdrew from the trial or were lost to follow-up (MMR, n = 0; non-surgical care, n = 11). The magnitude of improvement from baseline to 1 year was significantly greater in subjects who received MMR in both primary outcomes of KOOS Pain (P = 0.013) and KOOS Overall (P = 0.027). Treatment cessation was reported in 14.5% of non-surgical care subjects and only 4.9% of MMR subjects (n.s.).ConclusionTreatment with the synthetic MMR implant resulted in significantly greater improvements in knee pain, function, and quality of life at 1 year of follow-up compared to treatment with non-surgical care alone.Level of evidenceI.

Highlights

  • The meniscus plays vital protective roles in the knee, which include supporting joint stability as well as absorption and distribution of loads that are generated during normal weight-bearing and gait [3]

  • A 2019 systematic review and meta-analysis of asymptomatic, uninjured knees reported that a meniscal tear was observed via magnetic resonance imaging (MRI) in 4% of individuals under 40 years of age and 19% of individuals at least 40 years of age [8]

  • This study reports the 1-year midpoint results from this 2-year clinical trial

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Summary

Introduction

The meniscus plays vital protective roles in the knee, which include supporting joint stability as well as absorption and distribution of loads that are generated during normal weight-bearing and gait [3]. Depending on their size and location, meniscal tears can disrupt these protective functions, resulting in altered joint biomechanics and increased contact pressure on the articular cartilage and bone, with pain and disability as common outcomes [9, 23, 26]. Among patients with knee pain, the incidence of meniscal tears on MRI has been reported to exceed 70% [10]. Maintaining meniscal function is critical to supporting mobility and the long-term health of the knee

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