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NCT05985772
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
Conditions: Meniscus Tear, Tibial
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Rush University Medical Center
Location: Rush University Medical Center Chicago Illinois
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).
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.
* 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
Source: ClinicalTrials.gov (NCT05985772). StuddyBuddy aggregates publicly available trial information.