Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Repair of the Shoulder
• Intervention / Treatment: Device: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)

• Study Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

• Study Contact: Name: Kathleen Derwin, PhD; Phone Number: 216-408-7930; Email: derwink@ccf.org
• Study Contact Backup: Name: Cathy Shemo, BS; Phone Number: 216-218-1722; Email: shemoc@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Kathleen Derwin, PhD; Phone Number: 216-408-7930; Email: derwink@ccf.org
      • Contact: Cathy Shemo, BS; Phone Number: 216-218-1722; Email: shemoc@@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary arthroscopic rotator cuff repair

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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™.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcome measures	Patients will be asked to answer the American Shoulder and Elbow Surgeons (ASES) Score from 0-100 points where higher score indicates better outcome.	1 year post-operation
Shoulder strength	Isometric shoulder strength in pounds will be assessed using a table mounted dynamometer.	1 year post-operation
Shoulder range of motion	Shoulder range-of-motion will be assessed by asking patients to lift their affected arm overhead in the scapular plane and measuring the range with a manual goniometer (degrees).	1 year post-operation

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Kathleen Derwin, PhD, The Cleveland Clinic; Principal Investigator: Eric Ricchetti, MD, The Cleveland Clinic

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: rotator cuff tear; shoulder; rotator cuff repair; collagen suture
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Ulcer Agents; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: 25-252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes