BEAR Implant for Meniscus Repair
This study is looking at a new way to help meniscus tears heal. It's testing the BEAR Implant, which is a special collagen (a type of protein) scaffold that helps promote healing in the knee. Researchers want to see if adding the BEAR Implant to a standard meniscal repair procedure (arthroscopic suturing of torn fragments) improves how well people recover. They will compare outcomes in patients who receive the BEAR Implant with those who only have the standard repair. Success will be measured by changes in knee function and pain scores over one year. You might be able to join if you are 18 to 75 years old and have a meniscus injury that needs repair, but not if you have certain other conditions like displaced bucket-handle tears or blood-borne diseases. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 80 participants. It compares a standard meniscal repair with a meniscal repair that also uses the BEAR Implant.
- What's involved
- You would undergo a meniscal repair procedure, which involves arthroscopic suturing and takes about 20 minutes. You would have follow-up assessments at baseline and one year after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after the procedure to assess changes in knee function and pain.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair
At a glance
Conditions
NCT06041763
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
NYU Langone Health
New York, New Yorkno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Guillem Gonzalez-Lomas, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Exclusion
What this trial measures
- Change in International Knee Documentation Committee (IKDC) Subjective Knee Form ScoreBaseline, 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).
- Change in Lysholm Scale ScoreBaseline, 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.
- Change in Visual Analogue Scale (VAS) ScoreBaseline, 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.
- Incidence of Repair FailureUp to 1 Year Post-Procedure
Instances of failure of the meniscal repair.