Actively Recruiting
Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial
Led by NYU Langone Health · Updated on 2026-02-25
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of the bridge-enhanced ACL repair (BEAR) implant, a collagen-based scaffold loaded with the patient's own blood, to support healing after meniscus tears in the knee. This trial compares clinical outcomes and inflammation markers in the knee joint fluid between patients undergoing meniscus repair with or without the BEAR implant. The goal is to understand how this implant affects recovery in patients with isolated meniscal injuries. The study involves two groups of adult patients with meniscus injuries needing isolated repair. One group will receive standard arthroscopic meniscus repair, which involves suturing the torn meniscus fragments. The other group will have this repair plus insertion of the BEAR implant during surgery. The implant, made from sterilized bovine collagen and extracellular matrix, is placed through arthroscopic portals and is absorbed within 8 weeks, being replaced by new repair tissue. Participants will be followed for up to one year after their procedure. Researchers will assess knee function and pain using the International Knee Documentation Committee (IKDC) Subjective Knee Form, Lysholm Scale, and Visual Analogue Scale (VAS) at baseline and one year. They will also monitor the rate of repair failure during this time. The study is randomized and single-blinded, ensuring careful comparison of outcomes between the two groups.
CONDITIONS
Brief Title
Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of meniscus injury indicated for isolated repair
- No ligament reconstruction, cartilage repair, or osteotomy planned
- Age between 18 and 75 years
You will not qualify if you...
- Undergoing meniscal repair for displaced bucket-handle meniscal tears
- History of blood-borne diseases including HIV, hepatitis B or C, human T-lymphotropic virus, or syphilis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with implant resorption over 8 weeks
Participants undergo meniscal repair surgery. In the experimental group, the BEAR implant will be inserted during the procedure to assist repair. The implant is resorbed within 8 weeks and replaced with repair tissue.
1 surgery visit (in-person)
Duration - Up to 1 year post-procedure
Participants are followed for up to 1 year after the procedure to assess knee function, pain, and repair integrity.
Visits at baseline and 1 year post-procedure
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
E
Emma Trasatti
S
Samy Shelbaya
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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