Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775004
Status:
RECRUITING
Last Update Posted:
2022-07-13
First Post:
2021-02-24
Brief Title:
Comparing Meniscal Repair Biologic Augmentation Marrow Venting Procedure Versus PRP MVP Trial
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Comparing Meniscal Repair Biologic Augmentation Marrow Venting Procedure Versus PRP MVP Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
RECRUITING
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:
None
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?:
None