Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 20, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Meniscus Tear
Interventions
PROCEDURE

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.

DEVICE

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.

Trial Locations (1)

10016

RECRUITING

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER