Status:
RECRUITING
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)
Conditions:
Meniscus Tear, Tibial
Eligibility:
All Genders
18+ years
Phase:
NA
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. Furthe...
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 random...
Eligibility Criteria
Inclusion
- MRI-verified isolated tibial medial meniscus root tear
- Subject must be 18 years of age or older
Exclusion
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05985772
Start Date
April 20 2022
End Date
March 1 2028
Last Update
August 21 2025
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612