Comparing surgery and non-surgery for meniscus root tears
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
This study is testing whether surgery or non-surgery options are better for relieving pain and improving function in men with meniscus root tears.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05985772 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the differences in pain, functional outcomes, and imaging results between non-operative management and surgical repair of posterior-medial meniscal root tears. A total of 140 participants will be randomly assigned to either receive non-operative treatment, including analgesics and physical therapy, or undergo surgical repair. Participants will be monitored for subjective improvement and may crossover to surgery if necessary. The study will also track long-term outcomes to better understand the natural history of meniscal root tears and their treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with MRI-verified isolated tibial medial meniscus root tears.
Not a fit: Patients with concurrent knee ligament injuries or severe osteoarthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for meniscal root tears, potentially improving patient outcomes.
How similar studies have performed: Previous studies have explored similar treatment approaches, but this trial aims to provide more definitive comparisons between operative and non-operative management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jorge Chahla, MD — Rush University Medical Center Associate Professor and Surgeon
- Study coordinator: Carla M. Edwards, PhD
- Email: carla_edwards@rush.edu
- Phone: 312-563-5735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.