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Zimmer ActivBraid Rotator Cuff Repair (RCR) Study
Sponsor: The Cleveland Clinic
Summary
We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y.
Official title: Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
65
Start Date
2025-08-11
Completion Date
2029-08
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)
ActivBraid™ is a suture made from approximately half ultra-high molecular weight polyethylene and and half collagen derived from cow skin. Collagen is the most abundant protein in our bodies and serves as the building block for tendons and bones. The collagen in ActivBraid™ is intended to enhance cell attachment and tissue integration which may improve the healing of a rotator cuff repair. ActivBraid™ suture has been shown to have equivalent strength as other high strength sutures used in orthopaedic procedures and has been approved by the Food and Drug Administration (FDA) for repairing tendons. ActivBraid™ is a commercially available product that has been and is used in humans. This is the first post-market clinical study with ActivBraid™.
Locations (2)
Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States