Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-01 @ 11:07 AM
Study NCT ID:
NCT04775004
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2021-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: