Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

NYU Langone Health

Status: Enrolling

Conditions: Meniscus Tear

Treatments: Device: BEAR Implant; Procedure: Meniscal Repair Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06041763

23-00813

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

BEAR Implant

Experimental group

Description:

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

Treatment:

Procedure: Meniscal Repair Procedure

Device: BEAR Implant

Standard Repair

Active Comparator group

Description:

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.

Treatment:

Procedure: Meniscal Repair Procedure