BMVP vs PRP for Meniscal Tears

Recruiting at 2 trial locations

Overseen By Justin Bell

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

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

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate (surgical procedure)

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to repair meniscal tears in the knee: Bone Marrow Venting Procedure (BMVP) and Platelet Rich Plasma (PRP) injections. Researchers aim to determine which method more effectively reduces repair failure and the need for additional surgery. Eligible participants have specific types of meniscal tears and are not undergoing other major knee surgeries simultaneously. This study could advance future knee repair techniques. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance knee repair methods.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both the Bone Marrow Venting Procedure (BMVP) and Platelet Rich Plasma (PRP) are generally safe and well-tolerated for repairing meniscus tears.

Research indicates that BMVP significantly enhances meniscus healing. One study found a 100% healing rate with BMVP, compared to 76% without it. BMVP carries low risk, with no significant evidence of serious side effects.

PRP effectively reduces pain and improves knee function in meniscus injuries. Patients receiving PRP injections often experience significant pain relief and return to activities more quickly, with minimal side effects.

Both treatments have demonstrated promise in improving meniscus healing, with low risks of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for meniscal tears because they offer innovative approaches compared to standard options like physical therapy or surgery. The Bone Marrow Venting Procedure (BMVP) is unique as it aims to promote healing by releasing growth factors from bone marrow, potentially enhancing tissue repair. On the other hand, Platelet Rich Plasma (PRP) uses concentrated platelets from the patient's own blood to boost healing through growth factor release. Both treatments focus on stimulating the body's natural healing processes, which could lead to faster recovery and improved outcomes for patients with meniscal tears.

What evidence suggests that this trial's treatments could be effective for meniscal tears?

This trial will compare the Bone Marrow Venting Procedure (BMVP) and Platelet Rich Plasma (PRP) injections for treating meniscal tears. Research has shown that BMVP significantly improves meniscus healing, achieving a 100% success rate compared to 76% without it, suggesting it could greatly enhance the chances of successful meniscus repair. Meanwhile, PRP effectively reduces pain and improves knee function in individuals with meniscal injuries, potentially allowing athletes to return to sports more quickly due to shorter recovery times. This trial studies both methods to determine their effectiveness in enhancing meniscus repairs. ^{1 2 6 7 8}

Who Is on the Research Team?

Aravind Athiviraham, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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

Bone marrow venting procedure (BMVP) is already approved in United States, European Union for the following indications:

Approved in United States as Bone Marrow Venting Procedure for:

• Meniscal repair augmentation

Approved in European Union as Bone Marrow Venting Procedure for:

• Meniscal repair augmentation

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

American Orthopaedic Society for Sports Medicine

Collaborator

Trials

8

Recruited

2,100+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

Bone marrow concentrate (BMC) has a significantly higher concentration of the anti-inflammatory interleukin 1 receptor antagonist (IL-1Ra) compared to other preparations, making it a potentially more effective treatment for osteoarthritis and post-surgical healing.

Leukocyte-rich PRP (LR-PRP) shows higher concentrations of growth factors like platelet-derived growth factor (PDGF) and matrix metalloproteinases (MMPs), suggesting it may be optimal for enhancing vascularity and healing in injured tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Ziegler, CG., Van Sloun, R., Gonzalez, S., et al.[2020]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30902532/

A Prospective, Randomized, Double-Blind, Parallel-Group, ...

BMVP augmentation results in a significant improvement in the rate of meniscus healing (100% vs. 76%, P = .0035).

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04775004

Comparing Meniscal Repair Biologic Augmentation ...

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. Official ...

3.

arthroscopyjournal.org

arthroscopyjournal.org/article/S0749-8063(23)00288-8/fulltext

Biologic Stimulation Using Marrow Venting for Meniscus ...

Strong consideration should be given to biologic stimulation for all meniscal repairs, and the most cost effective technique is marrow stimulation.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11058150/

The Impact of Bone Marrow Venting Augmentation on Knee ...

The aim of this study was to compare the knee functional outcomes of patients with vertical/longitudinal meniscus tears who underwent either isolated repair.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0749806323001986

Platelet-Rich Plasma and Marrow Venting May Serve as ...

Platelet-Rich Plasma and Marrow Venting May Serve as Cost-Effective Augmentation Techniques for Isolated Meniscal Repair: A Decision-Analytical Markov Model– ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11156815/

Biologic Augmentation of Isolated Meniscal Repair - PMC

Another study confirmed the effectiveness of marrow venting procedures (MVP) in combination with meniscal repair for those with defects of both ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05053646

This is a Study to Verify if Marrow Venting Procedure Can ...

Meniscal suture represents the current surgical practice, and marrow venting is a low risk procedure. Bone venting may be able to improve the outcome of ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0749806318311423

Repair Augmentation of Unstable, Complete Vertical ...

To compare the effectiveness and safety of meniscal repair in 2 groups of patients: meniscal repair with biological augmentation using a bone marrow venting ...