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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06041763
Other study ID # 23-00813
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date October 1, 2025

Study information

Verified date February 2024
Source NYU Langone Health
Contact Isabel Wolfe
Phone (207)-749-6369
Email isabel.wolfe@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date October 1, 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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 with a fibrovascular repair tissue.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score 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). Baseline, 1 Year Post-Procedure
Primary Change in Lysholm Scale Score 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. Baseline, 1 Year Post-Procedure
Primary Change in Visual Analogue Scale (VAS) Score 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. Baseline, 1 Year Post-Procedure
Primary Incidence of Repair Failure Instances of failure of the meniscal repair. Up to 1 Year Post-Procedure
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