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

NCT ID: NCT05985772

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2028-03-31

Brief Summary

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).

Detailed Description

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.

Conditions

Meniscus Tear, Tibial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Non-operative Control (ARM 1)

Subjects randomized to 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.

Group Type: ACTIVE_COMPARATOR

Non-Operative Pain Management

Intervention Type: OTHER

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 Intervention (ARM 2)

Subjects randomized to the operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment. All surgically treated subjects, regardless if repairs were performed acutely or after cross over, will receive identical postoperative rehabilitation.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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)

Interventions

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.

Intervention Type: OTHER

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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.
• Pregnancy
• Subjects < 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)

UNKNOWN

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Chahla, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center Associate Professor and Surgeon

Locations

Rush University Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carla M. Edwards, PhD

Role: CONTACT

carla_edwards@rush.edu

312-563-5735

Jorge Chahla, MD

Role: CONTACT

jorge.chahla@rushortho.com

(312) 432-2818

Facility Contacts

Carla M Edwards, PhD

Role: primary

carla_edwards@rush.edu

312-563-5735

Other Identifiers

19082802

Identifier Type: -

Identifier Source: org_study_id