Recruiting

ActivBraid™ Collagen Co-Braid

Sponsor:

The Cleveland Clinic

Code:

NCT06971497

Conditions

Rotator Cuff Repair of the Shoulder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)

Study Details

Brief 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

Study ID

NCT06971497

Start date

Aug 11, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-75 years
  • acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons

Exclusion Criteria:

  • prior ipsilateral shoulder surgery
  • outstanding worker's compensation claim
  • symptomatic cervical spine disease
  • a frozen shoulder
  • advanced glenohumeral arthritis
  • isolated subscapularis tear
  • significant radiation exposure for other medical reasons.
  • known is advance to be claustrophobic
  • known history of hypersensitivity to bovine-derived materials.

Study Design

Enrollment

65 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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™.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kathleen Derwin, PhD

216-408-7930derwink@ccf.org

Cathy Shemo, BS

216-218-1722shemoc@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kathleen Derwin, PhD

216-408-7930derwink@ccf.org

Cathy Shemo, BS

216-218-1722shemoc@@ccf.org

Principal Investigator:

Kathleen Derwin, PhD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kathleen Derwin, PhD

216-408-7930derwink@ccf.org

Cathy Shemo, BS

216-218-1722shemoc@@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • rotator cuff repair
  • shoulder
  • rotator cuff tear
  • collagen suture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-28.