What this study is
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).
What's being tested
- Non-Operative Pain Management
Intervention · OTHER
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.
- Operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment
Intervention · PROCEDURE
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)
Study details
- Sponsor
- Rush University Medical Center
- Conditions
- Meniscus Tear, Tibial
- Enrolling
- 140 people
- Starts
- 2022-04-20
- Est. completion
- 2028-03
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- MRI-verified isolated tibial medial meniscus root tear
- Subject must be 18 years of age or older
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRush University Medical Center
Chicago, Illinois, United States
- Carla M Edwards, PhD · Contact312-563-5735carla_edwards@rush.edu
- Jorge Chahla, MD, PhD · Principal investigator
- Adam Yanke, MD · Sub-investigator
Recruiting
Study team
Sponsor
Rush University Medical Center
Study ID 19082802
Principal investigator
Jorge Chahla, MD
Rush University Medical Center Associate Professor and Surgeon
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.