The MeTeOR Trial (Meniscal Tear in Osteoarthritis Research): Rationale and design features

Abstract

This paper presents the rationale and design features of the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research; Clinical Trials.gov NCT00597012). MeTeOR is an NIH-funded seven-center prospective randomized controlled trial (RCT) designed to establish the efficacy of arthroscopic partial meniscectomy combined with a standardized physical therapy program as compared with a standardized physical therapy program alone in patients with a symptomatic meniscal tear in the setting of mild to moderate knee osteoarthritic change (OA). The design and execution of a trial that compares surgery with a nonoperative treatment strategy presents distinctive challenges. The goal of this paper is to provide the clinical rationale for MeTeOR and to highlight salient design features, with particular attention to those that present clinical and methodologic challenges.Sydney Medical Schoo

Predictors and Outcomes of Crossover to Surgery from Physical Therapy for Meniscal Tear and Osteoarthritis

“…Subjects with Kellgren-Lawrence Grade-4 changes (>50% joint space narrowing) were excluded. Details of the study design, subject selection and enrollment, randomization, and outcome assessment have been reported previously 6,10 . Briefly, eligible subjects were randomized to receive either APM with a standardized PT regimen or the PT regimen alone without surgery.…”

Surgery versus Physical Therapy for Meniscal Tear and Osteoarthritis

“…Scores on both scales range from 0 to 100, with higher KOOS scores indicating more severe pain and higher SF-36 scores indicating greater physical activity. 17 We also considered a binary outcome that was defined as improvement in the WOMAC physical-function score of at least 8 points (a clinically relevant difference specified a priori 10,18,19 ) without crossover to the other study group.…”

“…We prespecified one subgroup analysis based on the baseline radiographic grade (Kellgren-Lawrence grade 0 to 2 vs. Kellgren-Lawrence grade 3). 10,22 Additional analyses with adjustment for uncertainty due to missing data are described in the Supplementary Appendix. 23 We powered the study to detect a 10-point difference in the WOMAC physical-function score between the arthroscopic-partial-meniscectomy and physical-therapy groups.…”

“…The protocol was based on literature supporting the effectiveness of land-based, individualized physical therapy with progressive home exercise for patients with knee osteoarthritis. 10,12,13 The threestage structured program was designed to address inflammation, range of motion, concentric and eccentric muscle strength, muscle-length restrictions, aerobic conditioning (e.g., with the use of a bicycle, elliptical machine, or treadmill), functional mobility, and proprioception and balance. Details of the physical-therapy program are described in Table 2 in the Supplementary Appendix.…”

Comparison of arthroscopic partial meniscectomy with physical therapy alone co existing meniscal tear and knee osteoarthritis

“…The rest of the weeks, exercises was designed to increase endurance through increasing the number of repetitions The protocol was based on literature supporting the effectiveness of land-based, individualized physical therapy with progressive home exercise for patients with knee osteoarthritis. [3][4][5] The program was designed to address inflammation, range of motion, concentric and eccentric muscle strength, muscle-length restrictions, aerobic conditioning (e.g., with the use of a bicycle, elliptical machine, or treadmill), functional mobility, and proprioception and balance. Patients progressed at their own pace; the duration of participation varied depending on the pace of improvement.…”