Recruiting

BEAR

Sponsor:

NYU Langone Health

Code:

NCT06041763

Conditions

Meniscus Tear

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Meniscal Repair Procedure

BEAR Implant

Study Details

Brief summary:

The bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole blood. It is designed to promote healing in the setting of intraarticular knee pathology. This study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the BEAR implant.

Conditions

Meniscus Tear

Study ID

NCT06041763

Start date

Nov 20, 2024

Status verified date

Feb, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BEAR Implant

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

active comparator: Standard Repair

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.

Interventions

Meniscal Repair Procedure

All meniscal repairs will be performed by the surgeons who are listed as investigators for the study. Meniscal repair consists of arthroscopic suturing of torn fragments. This takes approximately 20 minutes. In the interventional group, the BEAR implant will be inserted through preexistent arthroscopic portals after repair is complete. This will take an additional 2 minutes.

BEAR Implant

The BEAR Implant (22 mm in diameter and 45mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam inadiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.

Primary outcome measure

  • Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score [ Time Frame: Baseline, 1 Year Post-Procedure ]
  • Change in Lysholm Scale Score [ Time Frame: Baseline, 1 Year Post-Procedure ]
  • Change in Visual Analogue Scale (VAS) Score [ Time Frame: Baseline, 1 Year Post-Procedure ]
  • Incidence of Repair Failure [ Time Frame: Up to 1 Year Post-Procedure ]

Central Contacts and Locations

Central contacts

Emma Trasatti

856-885-3259Emma.trasatti@nyulangone.org

Samy Shelbaya

517-575-5522samy.shelbaya@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-25.