Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)

Rush University Medical Center140 enrolled

Overview

The purpose of this study is to determine differences in pain, functional patient reported outcomes, and objective imaging parameters following non-operative and meniscus root repair treatment. Furthermore, the long-term goal of this research proposal is to understand the natural history of meniscal root tears and their subsequent repair, in order to better determine risk factors for inferior outcomes and progression to osteoarthritis (OA).

This study is a pragmatic design, parallel group, randomized clinical trial in which 140 subjects with a diagnosed medial meniscus root tear based on MRI and confirmed intra-operatively will be randomized to one of two treatment arms. The first group (ARM 1) will be treated non-operatively with analgesics, physical therapy, and will be kept non-weight bearing for 6 weeks (to match the postoperative protocol). If no subjective improvement is seen at 3 months, crossover will be allowed to a transtibial medial meniscal root repair (acute operative pathway (ARM 2) (CONSORT Flow Diagram)) as determined by 3 month patient reported outcomes (PROs and operating study physician approval. The second group (ARM 2) will be treated acutely with a transtibial medial meniscus root repair and will be non-weight bearing for 6 weeks as well. A previously published protocol will be used to standardize the rehabilitation. (14) Subjects will be followed with patient reported outcomes, serial radiographs (3 views), and a magnetic resonance imaging (MRI) scan at 12 months to determine repair status, meniscal extrusion, and presence of degenerative changes. Subjects who crossover at 3 months will be evaluated using additional MRI imaging prior to assignment to the acute operative meniscal root repair pathway (ARM 2). These subjects will crossover from ARM 1 to ARM 2 without first performing the ARM 1, 3 month radiograph (x-rays-3 views). The 3-month radiograph (x-rays-3 views) will be performed 3 months post-operative.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Interventions

Non-Operative Pain ManagementOTHER

The non-operative treatment arm will receive analgesics, physical therapy and will remain non-weight bearing. This will consist in anti-inflammatory drugs daily for 8-12 weeks and supervised physical therapy at least twice a week over a period of 8 weeks. Subjects in the non-operative arm will be offered the opportunity to crossover to the operative arm (ARM 2) of the study if the subjects do not report symptomatic improvement within 3 months after entry in this study.

Operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollmentPROCEDURE

The operative treatment group (ARM 2) will be treated acutely with a transtibial medial meniscus root repair and will be non-weight bearing for 6 weeks as well. For ARM 1 subjects if no subjective improvement is seen at 3 months, crossover will be allowed to a transtibial medial meniscal root repair (acute operative pathway (ARM 2)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * MRI-verified isolated tibial medial meniscus root tear * Subject must be 18 years of age or older Exclusion Criteria: * Concurrent ligamentous knee pathology requiring surgical intervention (i.e. anterior cruciate ligament tear, posterior cruciate ligament tear, posterolateral corner injury, high-grade medial collateral ligament tear), * Preoperative Kellgren-Lawrence grade of 3 or 4 * Inability to complete outcome questionnaires or comply with required postoperative imaging or MRI requirements, or medical contraindications to surgery or physical therapy. * There will be no exclusion criteria regarding body mass index (BMI) or mechanical alignment, however subjects will be stratified in groups for further analysis (BMI less and over 35 and varus alignment below and over 3º of varus). * Pregnancy * Subjects \< 18 years of age

Outcomes

Primary Outcomes

Visual analogue scale (VAS) for pain

The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.