Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
65 participants
OBSERVATIONAL
2025-08-11
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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™.
Interventions
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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™.
Eligibility Criteria
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Inclusion Criteria
* acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
The Cleveland Clinic
OTHER
Responsible Party
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Kathleen Derwin, PhD
Associate Staff Scientist
Principal Investigators
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Kathleen Derwin, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Eric Ricchetti, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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product information for ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)
Other Identifiers
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25-252
Identifier Type: -
Identifier Source: org_study_id
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