Using a collagen implant to enhance meniscus repair in the knee
Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial
This study is testing if a special collagen implant can help people heal better after surgery for a torn meniscus in the knee compared to standard repair methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06041763 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the bridge-enhanced ACL repair (BEAR) implant, a collagen-based scaffold loaded with whole blood, in promoting healing during isolated meniscal repair. The study compares clinical outcomes and synovial fluid cytokine profiles in patients who receive the BEAR implant versus those who undergo standard meniscal repair without the implant. The goal is to determine if the BEAR implant can improve healing and recovery in patients with meniscus tears.
Who should consider this trial
Good fit: Ideal candidates are individuals with a history of meniscus injury who are indicated for isolated repair without additional knee procedures.
Not a fit: Patients with displaced bucket-handle meniscal tears or those with a history of blood-borne diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing outcomes and faster recovery for patients with meniscus tears.
How similar studies have performed: While the BEAR implant approach is relatively novel, similar studies in knee repair have shown promising results in enhancing healing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • History of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy. Exclusion Criteria: * Patients who are undergoing meniscal repair for displaced bucket-handle meniscal tears * Patients with a history of blood-borne diseases including HIV, hepatitis B virus, hepatitis C virus, human T-lymphotropic virus, and syphilis
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Guillem Gonzalez-Lomas, MD — NYU Langone Health
- Study coordinator: Emma Trasatti
- Email: Emma.trasatti@nyulangone.org
- Phone: 856-885-3259
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.