Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06041763
Status
Recruiting
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Conditions

  • Meniscus Tear

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Meniscal Repair Procedure — 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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 20, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score [ Time Frame: Baseline, 1 Year Post-Procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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