Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Conditions

• Rotator Cuff Repair of the Shoulder

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) — DEVICE
  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™.

Study Details

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.

Key Dates

Start date

Aug 11, 2025

Status verified

Aug 2025

Primary completion

Aug 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

65 participants (estimated)

Arms

• Arm: patients undergoing primary arthroscopic rotator cuff repair
  Patients undergoing primary arthroscopic rotator cuff repair will have their repair completed with ActivBraid™Collagen Co-Braid suture (Zimmer Biomet).

Primary Outcome Measure

Rotator cuff repair healing [ Time Frame: 1 year post-operation ]

Central Contacts

• Kathleen Derwin, PhD
  216-408-7930
  [email protected]
• Cathy Shemo, BS
  216-218-1722
  [email protected]

Locations (2)

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