Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
NCT ID: NCT04775004
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
146 participants
INTERVENTIONAL
2021-07-19
2026-12-31
Brief Summary
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The proposed interventional aim to compare meniscal repair augmentation methods is novel, as the direct comparison of these outcome measures has not been previously described. Because of the known benefit of biologic augmentation of meniscal repair, the investigators hypothesize that the repair failure rate for both cohorts will be lower than the reported repair failure rate for isolated tears without biologic augmentation; the investigators also hypothesize that BMVP of the intercondylar notch will clinically be significantly better than intra-articular PRP injection. The basis behind this hypothesis is in vivo evidence as well as a small RCT supporting the use of BMVP as augmentation for meniscal repair procedures.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bone marrow venting procedure (BMVP)
Subjects randomized in the OR to undergo BMVP surgical augmentation
Bone marrow venting procedure (BMVP)
The BMVP involves creating small holes in a non-weight bearing area of the bone that does not have any important structures; the holes act as channels, which allow for flow of the participants own biologic products and stem cells from within the bone marrow.
Platelet rich plasma (PRP)
Subjects randomized in the OR to undergo PRP surgical augmentation
Platelet Rich Plasma (PRP)
The PRP group will have 40cc to 60cc (about 3 tablespoons) of blood drawn at the time of surgery. The blood sample will then be prepared in a centrifuge machine to collect a component of the blood called platelet rich plasma. Once appropriate concentrations of the PRP are confirmed, the PRP will be injected into the subject's knee prior to wound closure.
Interventions
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Bone marrow venting procedure (BMVP)
The BMVP involves creating small holes in a non-weight bearing area of the bone that does not have any important structures; the holes act as channels, which allow for flow of the participants own biologic products and stem cells from within the bone marrow.
Platelet Rich Plasma (PRP)
The PRP group will have 40cc to 60cc (about 3 tablespoons) of blood drawn at the time of surgery. The blood sample will then be prepared in a centrifuge machine to collect a component of the blood called platelet rich plasma. Once appropriate concentrations of the PRP are confirmed, the PRP will be injected into the subject's knee prior to wound closure.
Eligibility Criteria
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Inclusion Criteria
2. Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
4. 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
2. Patients with meniscus root tears
3. Patients undergoing repair for horizontal cleavage tears
4. Kellgren-Lawrence scale 3\>
5. Patients undergoing lateral release
6. Ipsilateral chondral lesion with Outerbridge classification of 3-4
7. Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery
8. Cortisone use within the six weeks prior to surgery
9. Utilizing worker's compensation at the time of screening
10. Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus.
11. Concomitant ligamentous insufficiency
12. Inflammatory rheumatic disease or other rheumatic disease
13. Immune compromised patients (hepatitis, HIV, etc.)
14. Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc)
15. History of distal femur, proximal tibia, or patellar fracture that was treated operatively
16. Non English-speaking patients
16 Years
ALL
No
Sponsors
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American Orthopaedic Society for Sports Medicine
OTHER
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Aravind Athiviraham, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Florida
Gainesville, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Marissa Pazik, MS
Role: primary
Justin Bell
Role: primary
Erica Hartzell, MS
Role: primary
Nina Cruz-Diaz
Role: backup
Other Identifiers
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IRB20-1394
Identifier Type: -
Identifier Source: org_study_id