Meniscus Tear Clinical Trial
Official title:
Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The results of this study will optimize the care for patients with a meniscus root tear. Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout technique is an effective treatment and will identify potential risk factors for poor clinical outcomes. In addition, investigators will determine if MRR is successful in delaying the radiographic progression of arthritis in the involved compartment.
Status | Enrolling by invitation |
Enrollment | 55 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Meniscus root avulsion tear (defined as meniscus posterior horn root avulsion or full thickness tear within 9 mm of the root attachment) 2. Age 18-65 3. Ligament injury with concomitant reconstruction is acceptable 4. Malalignment with corrective osteotomy is acceptable Exclusion Criteria: 1. Subchondral collapse on pre-op MRI 2. Extrusion greater than 3 mm 3. Intra-op Outerbridge grade 3 or greater chondromalacia 4. Intra-op poor quality meniscus tissue 5. Mal-alignment greater than 5 degrees without corrective osteotomy 6. Obesity with BMI over 40 7. Kellgren Lawrence > grade 2 8. Worker's compensation status |
Country | Name | City | State |
---|---|---|---|
United States | Columbia Orthopaedic Group | Columbia | Missouri |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Tegner activity score | Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10.
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport. |
baseline, 2 years |
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