Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)

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 augmentation of meniscal repair. However, the effectiveness of these augmentation methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this particular patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function as well as meniscal repair failure and reoperation rate.

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.

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Key information

Conditions

Meniscal Tear

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone marrow venting procedure (BMVP)

Other

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)

Other

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.

Primary outcomes

Promis Physical function CAT lower extremity score

Time frame: 1-year after meniscus tear operation.

Adaptive questionnaire that takes five minutes or less to complete and helps record how subject injury and recovery from surgery is affecting their normal life.

Secondary outcomes

Re-tear of repair meniscus

Time frame: 1-year after meniscus tear operation.

Clinically reported (symptomatic) and MRI confirmed via observation of fluid filled tear in the repaired tissue

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

American Orthopaedic Society for Sports Medicine

Registry information

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Mar 1, 2021
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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