MVP Trial
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StatusAccepting Candidates
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Age16 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
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.
Details
Full study title | Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP |
Protocol number | OCR40873 |
ClinicalTrials.gov ID | NCT04775004 |
Phase | N/A |
Eligibility
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:
Chondroplasty
Synovectomy
Loose body removal
"Contralateral" menisectomy (i.e. medial meniscus repair with a lateral menisectomy or lateral meniscus repair with a medial menisectomy) would be permitted for inclusion
Any other procedure that does not include drilling, requires prior approval of the study sponsor for each procedure
Exclusion Criteria
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
- Non English-speaking patients
Lead researcher
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Kevin W Farmer, MDOrthopaedic Surgeon, Sports Medicine Specialist
Participate in a study
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.