NCT06971497

Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Repair of the Shoulder

Interventions

Type	Name	Description
DEVICE	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™.

Timeline

• Start date: 2025-08-11
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2025-05-14
• Last updated: 2025-08-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study