Comparing two methods for enhancing meniscal tear repair
Comparing Meniscal Repair Biologic Augmentation: Marrow Venting Procedure Versus PRP (MVP Trial)
This study is testing which of two treatments, Bone Marrow Venting or Platelet Rich Plasma injections, works better for helping people with certain types of meniscal tears heal and recover.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 3 sites (Gainesville, Florida and 2 other locations) |
| Trial ID | NCT04775004 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two biologic augmentation methods for meniscal repair: the Bone Marrow Venting Procedure (BMVP) and Platelet Rich Plasma (PRP) injections. It seeks to determine which method provides better outcomes in terms of meniscal repair success and functional recovery. The study will involve patients aged 16 and older with specific types of meniscal tears and will track outcomes such as repair failure and reoperation rates. The research is novel as it directly compares these two augmentation techniques, which have not been previously evaluated against each other.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 or older with specific types of meniscal tears, including medial, lateral, vertical longitudinal, oblique, or radial tears.
Not a fit: Patients with meniscus root tears, horizontal cleavage tears, or those requiring cartilage restorative procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with meniscal tears, enhancing recovery and reducing the need for reoperations.
How similar studies have performed: While there is existing data supporting the use of both BMVP and PRP for meniscal repair, this study is novel as it directly compares these two methods, which have not been previously tested against each other.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Age 16 or older 2. Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear 3. 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 4. 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 1. Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others) 2. Patients with meniscus root tears 3. Patients undergoing repair for horizontal cleavage tears 4. Kellgren-Lawrence scale 3\> 5. Patients undergoing lateral release 6. Ipsilateral chondral lesion with Outerbridge classification of 3-4 7. Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery 8. Cortisone use within the six weeks prior to surgery 9. Utilizing worker's compensation at the time of screening 10. Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus. 11. Concomitant ligamentous insufficiency 12. Inflammatory rheumatic disease or other rheumatic disease 13. Immune compromised patients (hepatitis, HIV, etc.) 14. Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc) 15. History of distal femur, proximal tibia, or patellar fracture that was treated operatively 16. Non English-speaking patients
Where this trial is running
Gainesville, Florida and 2 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- University of Chicago Medicine — Chicago, Illinois, United States (Recruiting)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Aravind Athiviraham, MD — University of Chicago
- Study coordinator: Justin Bell
- Email: jbell3@bsd.uchicago.edu
- Phone: 773-834-0822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.