Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

NCT06971497 | Recruiting FDA Device

• 1 other identifier: 25-252
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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

Keywords

rotator cuff repair; shoulder; rotator cuff tear; collagen suture

Outcome Measures

Primary Outcomes (2)

• Rotator cuff repair healing

  Patients will undergo magnetic resonance imaging (MRI) of the shoulder from which healing of their rotator cuff repair will be classified using Sugaya score from 1-5, where higher score indicated worse healing.

  1 year post-operation

• Rotator cuff repair healing

  Patients will also undergo computed tomography (CT) scans of the shoulder from which tendon retraction of the rotator cuff repair will also be measured in millimeters where higher tendon retraction indicates worse healing.

  1 year post-operation

Secondary Outcomes (3)

• Patient-reported outcome measures

  1 year post-operation

• Shoulder strength

  1 year post-operation

• Shoulder range of motion

  1 year post-operation

Study Arms (1)

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).

Device: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)

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™.

patients undergoing primary arthroscopic rotator cuff repair

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary arthroscopic rotator cuff repair

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Zimmer Biomet: collaborator

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Links

• product information for ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Kathleen Derwin, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Eric Ricchetti, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Derwin, PhD

CONTACT

216-408-7930; derwink@ccf.org

Cathy Shemo, BS

CONTACT

216-218-1722; shemoc@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff Scientist

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 14, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)