What side effects are associated with this type of intervention?

The most common treatments for meniscal tears, such as BMVP and PRP, can have side effects including pain at the injection site, infection, and inflammation. BMVP, which uses bone marrow-derived stem cells, may also pose a risk of immune reactions. PRP therapy, which enhances tissue repair through concentrated platelets, shares similar risks of pain and infection. Both treatments aim to promote healing but carry inherent risks associated with biological therapies.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for treatments directly targeting meniscal tears using Bone Marrow Ventricular Plasma (BMVP) or Platelet-Rich Plasma (PRP). While PRP has been widely studied and used off-label for various musculoskeletal injuries, including meniscal tears, it has not received specific FDA approval for this indication. Similarly, treatments involving stem cells and growth factors, like BMVP, are still largely investigational and have not yet achieved FDA approval for meniscal repair.

What other types of research exist?

Promising novel alternatives to BMVP and PRP for meniscal tear treatment in 2024 include platelet-rich fibrin matrix (PRFM) and fibroblast growth factor-18 (FGF-18). PRFM has shown potential in enhancing tissue healing, and FGF-18 has demonstrated anabolic effects on cartilage, which may aid in meniscal repair.

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Procedure

BMVP vs PRP for Meniscal Tears

N/A

Recruiting

Led By Aravind Athiviraham, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Loose body removal

Age 16 or older

Must not have

Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others)

Patients with meniscus root tears

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year after meniscus tear operation.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial description does not specify side effects directly related to BMVP or PRP interventions being tested here, common risks may include pain at injection site, infection risk from the procedure itself, swelling or inflammation around the knee joint.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery to remove loose fragments in my joint.

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I am 16 years old or older.

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I have a tear in my knee's cartilage.

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I have had a synovectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery to fix or restore cartilage in my joints.

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I have a tear in the root of my meniscus.

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I am having surgery to fix a horizontal tear in my tissue.

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I am scheduled for or have had a lateral release surgery.

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I have a ligament problem in addition to my main condition.

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I haven't used nicotine products in the last 3 months.

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

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I have had surgery on the ligaments or meniscus of my affected limb.

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My joint disease is moderate to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year after meniscus tear operation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year after meniscus tear operation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year after meniscus tear operation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Promis Physical function CAT lower extremity score

Secondary study objectives

Re-tear of repair meniscus

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Platelet rich plasma (PRP)Active Control1 Intervention

Subjects randomized in the OR to undergo PRP surgical augmentation

Group II: Bone marrow venting procedure (BMVP)Active Control1 Intervention

Subjects randomized in the OR to undergo BMVP surgical augmentation

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Meniscal Tear, such as BMVP and PRP, work by enhancing the body's natural healing processes. BMVP uses bone marrow-derived stem cells to promote tissue repair and regeneration through differentiation and the release of growth factors. PRP involves injecting a concentrated solution of the patient's own platelets, which release growth factors that enhance tissue repair and reduce inflammation. These mechanisms are crucial for Meniscal Tear patients as they can potentially improve healing outcomes and reduce recovery times compared to traditional treatments.