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| Name | Class |
|---|---|
| American Orthopaedic Society for Sports Medicine | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone marrow venting procedure (BMVP) | Active Comparator | Subjects randomized in the OR to undergo BMVP surgical augmentation |
|
| Platelet rich plasma (PRP) | Active Comparator | Subjects randomized in the OR to undergo PRP surgical augmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Re-tear of repair meniscus | Clinically reported (symptomatic) and MRI confirmed via observation of fluid filled tear in the repaired tissue | 1-year after meniscus tear operation. |
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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:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Aravind Athiviraham, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States | ||
| University of Chicago Medicine |
Individual participant data will not be available to other researchers.
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| 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. |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |