Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meniscal Repair Procedure, BEAR Implant.
- Who it may be relevant to
- Registry conditions: Meniscus Tear. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial
Overview
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.
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
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06041763 · 23-00813