NCT05985772 · Rush University Medical Center
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
What this study is about
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.
View original scientific description
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).
Interventions
OTHER
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.
PROCEDURE
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)
Primary outcome measures
Visual analogue scale (VAS) for pain
Time frame: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
- Subjects \< 18 years of age
Where
- Chicago, Illinois
Collaborators
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2025 · Source of record for eligibility and locations