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

NCT04775004 | Active Not Recruiting

• 1 other identifier: IRB20-1394
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Meniscal Tear

Outcome Measures

Primary Outcomes (1)

• Promis Physical function CAT lower extremity score

  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.

  1-year after meniscus tear operation.

Secondary Outcomes (1)

• Re-tear of repair meniscus

  1-year after meniscus tear operation.

Study Arms (2)

Bone marrow venting procedure (BMVP)

ACTIVE COMPARATOR

Subjects randomized in the OR to undergo BMVP surgical augmentation

Other: Bone marrow venting procedure (BMVP)

Platelet rich plasma (PRP)

ACTIVE COMPARATOR

Subjects randomized in the OR to undergo PRP surgical augmentation

Other: Platelet Rich Plasma (PRP)

Interventions

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.

Platelet rich plasma (PRP)

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.

Bone marrow venting procedure (BMVP)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16 or older
• Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
• No other concomitant procedure unless one of the following:
• Chondroplasty
• Synovectomy
• Loose body removal
• Any other procedure that does not include drilling, requires prior approval of the study sponsor for each procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• American Orthopaedic Society for Sports Medicine: collaborator
• University of Chicago: lead

Study Sites (3)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Aravind Athiviraham, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: July 19, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)