BMVP vs PRP for Meniscal Tears

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Aravind Athiviraham, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Chicago

Must not be taking: Steroids, Immunosuppressants, Chemotherapy, Cortisone

Disqualifiers: Meniscus root tears, Rheumatic disease, Nicotine, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two methods to help heal knee injuries involving the meniscus. One method uses special plasma from bone marrow, and the other uses concentrated plasma from the patient's own blood. Both aim to speed up healing by providing extra nutrients. The study will determine which method is more effective. Plasma from the patient's own blood has been widely used in recent years for bone regeneration and wound healing, and it has shown potential benefits in meniscus repair.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used prednisone, other steroids, immunosuppressants, or chemotherapy one week before surgery, or if you plan to use them within six weeks after surgery. Also, cortisone use within six weeks prior to surgery is not allowed.

What data supports the effectiveness of the treatment BMVP and PRP for meniscal tears?

Research shows that the bone marrow venting procedure (BMVP) can help improve meniscal repair by providing biological support, while platelet-rich plasma (PRP) has been seen as a promising therapy to aid healing in meniscal injuries, especially in adolescents. ^{1 2 3 4 5}

Is the Bone Marrow Venting Procedure (BMVP) and Platelet-Rich Plasma (PRP) therapy safe for humans?

The Bone Marrow Venting Procedure (BMVP) and Platelet-Rich Plasma (PRP) therapy have been studied for their safety in various conditions, including meniscal repair and knee osteoarthritis. These treatments are generally considered safe, but their effectiveness and safety can vary depending on the specific condition being treated. ^{1 2 3 4 6}

How is the BMVP vs PRP treatment for meniscal tears different from other treatments?

The BMVP and PRP treatment for meniscal tears is unique because it uses the body's own biological materials to enhance healing, with BMVP involving a procedure to stimulate bone marrow and PRP using concentrated platelets from the patient's blood to promote tissue repair, unlike traditional surgical methods that may not focus on biological augmentation. ^{1 2 3 7 8}

Research Team

Aravind Athiviraham, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for individuals aged 16 or older with certain types of meniscal tears who haven't used cortisone, nicotine products, steroids, or immunosuppressants within specified time frames before surgery. It excludes those with ligament instability, immune compromise (like HIV), inflammatory diseases, undergoing certain knee procedures, non-English speakers, and those with a history of significant knee fractures.

Inclusion Criteria

Any procedure that does not include drilling, requires prior approval of the study sponsor for each procedure.

I need surgery to remove loose fragments in my joint.

My tear type is mainly one that qualifies me for the study, as confirmed by a doctor.

Exclusion Criteria

Ipsilateral chondral lesion with Outerbridge classification of 3-4

I had surgery for a fracture in my lower thigh, upper shin, or kneecap.

I have a tear in the root of my meniscus.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical augmentation with either PRP or BMVP

Immediate (surgical procedure)

1 visit (in-person, surgical)

Follow-up

Participants are monitored for function and meniscal repair failure

1 year

Regular follow-up visits (in-person and virtual)

Treatment Details

Interventions

• Bone marrow venting procedure (BMVP) (Procedure)
• Platelet Rich Plasma (PRP) (Procedure)

Trial Overview The MVP Trial compares two biological treatments to enhance meniscal repair: Bone Marrow Venting Procedure (BMVP) and Platelet Rich Plasma (PRP) injections. The study aims to determine which method better prevents repair failure in patients with meniscal tears by tracking their recovery and need for reoperation.

Participant Groups

Group I: Platelet rich plasma (PRP) Active Control 1 Intervention

Subjects randomized in the OR to undergo PRP surgical augmentation

Group II: Bone marrow venting procedure (BMVP) Active Control 1 Intervention

Subjects randomized in the OR to undergo BMVP surgical augmentation

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

American Orthopaedic Society for Sports Medicine

Collaborator

Trials

8

Recruited

2,100+

Findings from Research

In a study of 40 patients with complete vertical meniscus tears, meniscal repair combined with bone marrow venting procedure (BMVP) resulted in a significantly higher healing rate of 100% compared to 76% in the control group after 36 weeks (P = .0035).

Functional outcomes were also better in the BMVP group at 30 months, with significant improvements in knee function scores, and no adverse events were reported, indicating a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. Kaminski, R., Kulinski, K., Kozar-Kaminska, K., et al.[2022]

In a study involving 21 male rabbits with knee lesions, both platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) treatments showed improved articular surface remodeling compared to a control group, indicating their potential effectiveness in treating knee injuries.

The use of regenerative therapies like PRP and BMAC after surgery can enhance joint outcomes and reduce degeneration, suggesting they should be considered as valuable adjunct treatments in orthopedic practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing PRP and bone marrow aspirate effects on cartilage defects associated with partial meniscectomy: a confocal microscopy study on animal model. Lăzărescu, AE., Văduva, AO., Hogea, GB., et al.[2021]

A meta-analysis of 837 patients showed no significant differences in pain relief or functional outcomes between arthroscopic meniscal repair with and without platelet-rich plasma (PRP) augmentation, indicating that PRP may not enhance recovery.

The study found similar rates of surgical failure and revision between the two groups, suggesting that PRP augmentation does not provide additional benefits for meniscal repair procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma (PRP) augmentation does not result in more favourable outcomes in arthroscopic meniscal repair: a meta-analysis. Migliorini, F., Cuozzo, F., Cipollaro, L., et al.[2022]

In a study of 30 adolescents aged 12 to 17 with meniscal tears, platelet-rich plasma (PRP) treatment significantly reduced knee pain from an average score of 7.73 to 2.0 on the numerical rating scale after 3 months.

After PRP treatment, 76.7% of patients reported 'excellent' or 'good' outcomes, indicating that PRP can be an effective option for those who did not find relief from conservative management and physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolated Meniscus Tears in Adolescent Patients Treated with Platelet-Rich Plasma Intra-articular Injections: 3-Month Clinical Outcome. Popescu, MB., Carp, M., Tevanov, I., et al.[2022]

In a randomized controlled trial involving 90 participants with knee osteoarthritis, both autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) showed significant improvements in pain and function over 24 months, with no significant differences between the two treatments.

Both PRP and BMC led to sustained improvements in patient-reported outcomes, plateauing at 3 months and maintained through 24 months, indicating that neither treatment was superior to the other for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. Anz, AW., Plummer, HA., Cohen, A., et al.[2022]

In a study of 3420 patients, the use of BMAC or PRP augmentation did not significantly affect the revision rates after isolated meniscus repair, indicating that these biologic treatments may not enhance outcomes in this specific scenario.

However, for meniscus repairs performed alongside anterior cruciate ligament reconstruction (ACLR), BMAC or PRP augmentation was associated with a significantly lower revision rate (5.2% vs 7.9%), suggesting a potential benefit in this combined surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Biologic Augmentation on Revision Surgery Rates After Meniscus Repair: A Matched-Cohort Analysis of 3420 Patients. Dancy, ME., Marigi, EM., Krych, AJ., et al.[2023]

White-white meniscal tears, located in an avascular zone, are difficult to heal due to lack of blood supply, leading to accelerated cartilage degeneration and increased risk of osteoarthritis if the meniscus is removed.

The use of platelet-rich plasma (PRP) is proposed as a promising technique to enhance healing in these challenging meniscal tears, potentially offering a simple and effective solution in knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel hypothesis: the application of platelet-rich plasma can promote the clinical healing of white-white meniscal tears. Wei, LC., Gao, SG., Xu, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. [2022]

2. Romania pubmed.ncbi.nlm.nih.gov

Comparing PRP and bone marrow aspirate effects on cartilage defects associated with partial meniscectomy: a confocal microscopy study on animal model. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. [2020]

4. Italy pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma (PRP) augmentation does not result in more favourable outcomes in arthroscopic meniscal repair: a meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Isolated Meniscus Tears in Adolescent Patients Treated with Platelet-Rich Plasma Intra-articular Injections: 3-Month Clinical Outcome. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of Biologic Augmentation on Revision Surgery Rates After Meniscus Repair: A Matched-Cohort Analysis of 3420 Patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A novel hypothesis: the application of platelet-rich plasma can promote the clinical healing of white-white meniscal tears. [2023]