BEAR Implant for Meniscus Tears

Overseen By Michael Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Displaced meniscal tears, Blood-borne diseases

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for healing knee injuries, specifically meniscus tears, which occur in the knee's cushioning tissue. Researchers compare the outcomes of standard meniscus tear repairs with and without a special implant called the BEAR implant. Made of collagen, a protein that aids tissue healing, the implant is filled with blood to enhance recovery. This trial targets individuals with a meniscus injury requiring repair, excluding those with other knee issues like ligament tears or certain diseases. As an unphased trial, participants can contribute to groundbreaking research that may improve future knee injury treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the BEAR implant is safe for meniscus repair?

Research shows that the BEAR implant, used in knee surgeries, is generally safe. Studies comparing patients with the BEAR implant to those with traditional ACL (anterior cruciate ligament) repairs found similar levels of satisfaction and knee function after surgery.

Some patients have reported knee injuries like ACL tears or meniscal injuries after surgery. However, these are similar to those that might occur with other knee surgeries.

Made from collagen, the BEAR implant aids in better knee healing. It has been tested and used in other knee repairs, supporting its safety. While no treatment is without risk, current evidence suggests the BEAR implant is usually well-tolerated in knee repair surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BEAR Implant for meniscus tears because it offers a novel approach to healing. Unlike traditional treatments that involve standard meniscal repair, the BEAR Implant enhances the healing process by using a special scaffold that encourages the body's own tissue to repair the tear more effectively. This technique aims to improve recovery times and outcomes by promoting natural tissue regeneration, which could lead to better long-term joint health compared to current surgical options.

What evidence suggests that the BEAR Implant is effective for meniscus tears?

This trial will compare the effectiveness of a standard meniscal repair procedure with one using the BEAR Implant. Research has shown that the BEAR Implant can aid in repairing knee injuries. In earlier studies, patients who used the BEAR Implant for knee repair achieved results similar to those who underwent traditional ACL surgery. The chance of re-injury with the BEAR Implant was about 15%, considered low, suggesting that the knee remains stable. Early findings also indicate that the BEAR Implant supports tissue growth, aiding in the healing of knee injuries. Overall, the BEAR Implant appears promising for improving knee healing after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Guillem Gonzalez-Lomas, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with meniscus injuries that need repair but don't require other knee procedures like ligament reconstruction. Participants must not have blood-borne diseases such as HIV, hepatitis B or C, human T-lymphotropic virus, and syphilis.

Inclusion Criteria

I have a meniscus injury needing repair without other knee surgeries.

Exclusion Criteria

I am having surgery for a specific type of knee cartilage tear.

I have a history of blood-borne diseases like HIV or hepatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo isolated meniscal repair with or without the BEAR implant

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Meniscal Repair Procedure
• Meniscal Repair Procedure with BEAR Implant

Trial Overview The study tests a new BEAR implant against standard meniscal repair procedures. The BEAR implant uses a collagen scaffold with the patient's own blood to encourage healing in the knee joint.

How Is the Trial Designed?

Group I: BEAR Implant Experimental Treatment 2 Interventions

Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure.

Group II: Standard Repair Active Control 1 Intervention

adult patients with meniscus injury indicated for isolated meniscus repair. In the standard repair group, participants will undergo an isolated meniscus repair without the implant.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Biodegradable implants for meniscal repair, introduced in the 1990s, have been used since 1999, but there are documented cases of failure, including a foreign-body reaction and a new meniscus tear after trauma.

While meniscus refixation with bioabsorbable arrows is generally considered reliable, the potential for complications, such as granuloma formation and additional tears, should be carefully considered by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications after meniscal repair with bioabsorbable arrows: two cases and analysis of literature. Otte, S., Klinger, HM., Beyer, J., et al.[2016]

Biologic augmentation techniques, particularly platelet-rich plasma (PRP) and bone marrow stimulation, may reduce the risk of failure in isolated meniscal repairs, although they do not significantly improve knee symptom scores.

Current evidence is limited regarding the effectiveness of various augmentation methods, with fibrin clot techniques lacking sufficient support for reducing failure risk, while meniscal wrapping and scaffold implantation show promise for complex tears but require further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologic Augmentation during Meniscal Repair. Blough, CL., Bobba, CM., DiBartola, AC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965036/

Indications, Techniques, and Outcomes of Bridge-Enhanced ... Combining all three BEAR trials, there was an aggregate re-tear rate of 15%. Our post-market published BEAR data shows non-inferior short-term ...

2. trialx.com trialx.com/clinical-trials/listings/296158/bridge-enhanced-acl-repair-bear-in-meniscus-repair/

Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair This study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the BEAR ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212628722001906

Bridge-Enhanced Anterior Cruciate Ligament Repair for ... The subset of patients receiving BEAR who underwent a subsequent procedure had similar outcomes to those who underwent a single ACL reconstruction. The results ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322937/

Bridge-Enhanced Anterior Cruciate Ligament Restoration This preliminary study suggests that the outcomes of BEAR and ACLR with a hamstring tendon graft may be similar at the 6-year follow-up.

5. sabrinastrickland.com sabrinastrickland.com/bridge-registry-what-the-first-100-bear-patients-teach-us/

Bridge Registry: First 100 BEAR Patients | Dr. Sabrina Strickland Bridge Registry study: BEAR offers a promising ACL repair, showing high knee stability and low retear rates in the first 100 real-world ...

6. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/ksa.12806

Postcommercialisation outcomes of bridge‐enhanced anterior ... Adverse events between 1 and 2 years included one recurrent ACL tear with associated meniscus tears, two meniscal injuries without ACL tear, and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02292004

Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial) Complete ACL tear, confirmed by MRI · Time from injury to screening must be less than or equal to 90 days · ACL tissue present on pre-operative MRI.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200035.pdf

BEAR® (Bridge-Enhanced ACL Repair) Implant Various outcomes were measured at the follow-up visits, including patient-reported outcomes, strength and functional measurements and imaging (X-ray, magnetic ...