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

Not Applicable

Recruiting

• Conditions: Meniscal Tear
• Interventions: Other: Platelet Rich Plasma (PRP); Other: Bone marrow venting procedure (BMVP)

• Registration Number: NCT04775004
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Study Start: 2021-07-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma (PRP)	Platelet Rich Plasma (PRP)	Subjects randomized in the OR to undergo PRP surgical augmentation
Bone marrow venting procedure (BMVP)	Bone marrow venting procedure (BMVP)	Subjects randomized in the OR to undergo BMVP surgical augmentation

Primary Outcome Measures

Name	Time	Method
Promis Physical function CAT lower extremity score	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 Outcome Measures

Name	Time	Method
Re-tear of repair meniscus	1-year after meniscus tear operation.	Clinically reported (symptomatic) and MRI confirmed via observation of fluid filled tear in the repaired tissue

Trial Locations

Locations (3)

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States