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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Non-Operative Pain Management
  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.
• Процедура Operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment
  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)

Первичные конечные точки

• Visual analogue scale (VAS) for pain [Срок оценки: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)]

Вторичные конечные точки (4)

• Western Ontario Meniscal Evaluation Tool (WOMET) [Срок оценки: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)]
• Knee Osteoarthritis and Outcomes Score (KOOS) [Срок оценки: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)]
• European Quality of Life Scale (Euro-QoL) [Срок оценки: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)]
• Lysholm knee score [Срок оценки: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)]

Критерии участия

Критерии включения

• MRI-verified isolated tibial medial meniscus root tear
• Subject must be 18 years of age or older

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Rush University Medical Center — Chicago

Идентификаторы

NCT: NCT05985772 · 19082802

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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