Status:
RECRUITING
Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
American Orthopaedic Society for Sports Medicine
Conditions:
Meniscal Tear
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
There are no current or past RCT comparing biologic augments for meniscal repair. There is good data supporting both the use of BMVP of the intercondylar notch and intra-articular PRP injections for a...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 16 or older
- Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
- Complex tears may be included at the discretion of the site investigator if patient has one of tear patterns listed in inclusion criteria 2 as the most predominant finding
- No other concomitant procedure unless one of the following:
- Chondroplasty
- Synovectomy
- Loose body removal
- "Contralateral" menisectomy (i.e. medial meniscus repair with a lateral menisectomy or lateral meniscus repair with a medial menisectomy) would be permitted for inclusion
- Any other procedure that does not include drilling, requires prior approval of the study sponsor for each procedure
- Exclusion Criteria
- Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others)
- Patients with meniscus root tears
- Patients undergoing repair for horizontal cleavage tears
- Kellgren-Lawrence scale 3\>
- Patients undergoing lateral release
- Ipsilateral chondral lesion with Outerbridge classification of 3-4
- Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery
- Cortisone use within the six weeks prior to surgery
- Utilizing worker's compensation at the time of screening
- Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus.
- Concomitant ligamentous insufficiency
- Inflammatory rheumatic disease or other rheumatic disease
- Immune compromised patients (hepatitis, HIV, etc.)
- Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc)
- History of distal femur, proximal tibia, or patellar fracture that was treated operatively
- Non English-speaking patients
Exclusion
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04775004
Start Date
July 19 2021
End Date
December 31 2026
Last Update
November 14 2025
Active Locations (3)
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1
University of Florida
Gainesville, Florida, United States, 32611
2
University of Chicago Medicine
Chicago, Illinois, United States, 60637
3
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157