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NCT Number: NCT06041763

Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

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.

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Key information

Conditions

Meniscus Tear

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score

    Time frame: Baseline, 1 Year Post-Procedure

    10-item assessment of knee-related symptoms at the present moment and over the previous 4 weeks. Each item is rated according to presence of symptoms. The raw score is the sum of responses and is rescaled to a total score ranging from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  2. Change in Lysholm Scale Score

    Time frame: Baseline, 1 Year Post-Procedure

    8-item assessment of knee-related activity and problems at the present moment. Each item is rated on a Likert-type scale. The total score is the sum of responses and ranges from 0 to 100, with higher scores indicating greater level of function/lower level of symptoms.

  3. Change in Visual Analogue Scale (VAS) Score

    Time frame: Baseline, 1 Year Post-Procedure

    One-item assessment of pain on the current day. Pain is rated on a scale from 0 (no pain) to 10 (worst possible, unbearable, excruciating pain); the total score is the numerical rating.

  4. Incidence of Repair Failure

    Time frame: Up to 1 Year Post-Procedure

    Instances of failure of the meniscal repair.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Trasatti

CONTACT

[email protected]

856-885-3259

Samy Shelbaya

CONTACT

[email protected]

517-575-5522

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 18, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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