Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• MRI-verified isolated tibial medial meniscus root tear
• Subject must be 18 years of age or older
Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Carla M. Edwards, PhD
carla_edwards@rush.edu
312-563-5735
Backup
Jorge Chahla, MD
jorge.chahla@rushortho.com
(312) 432-2818
Time Frame
Start Date: 2022-04-20
Estimated Completion Date: 2028-03
Participants
Target number of participants: 140
Treatments
Active_comparator: Non-operative Control (ARM 1)
Subjects randomized to 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.
Experimental: Operative Intervention (ARM 2)
Subjects randomized to the operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment. All surgically treated subjects, regardless if repairs were performed acutely or after cross over, will receive identical postoperative rehabilitation.
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center
Collaborators: International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)