Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multi… (NCT05985772) | Clinical Trial Compass
RecruitingNot Applicable
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
United States140 participantsStarted 2022-04-20
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual analogue scale (VAS) for pain
Timeframe: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)