NCT06971497|RecruitingFDA Device
Zimmer ActivBraid Rotator Cuff Repair (RCR) Study
Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
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Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
Sponsor study identifier
observational
65
1 country
2
Study Start
August 11, 2025
Actual (reported)Primary Completion
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2025
Actual (reported)May 14, 2025
Actual (reported)August 11, 2025
Actual (reported)August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Patient-reported outcome measures
1 year post-operation
Shoulder strength
1 year post-operation
Shoulder range of motion
1 year post-operation
Patients undergoing primary arthroscopic rotator cuff repair will have their repair completed with 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™.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients undergoing primary arthroscopic rotator cuff repair
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Kathleen Derwin, PhD
The Cleveland Clinic
Eric Ricchetti, MD
The Cleveland Clinic
First Submitted
April 29, 2025
First Posted
May 14, 2025
Study Start
August 11, 2025
Actual (reported)Primary Completion
August 2029
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 28, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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