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Recruiting
NCT06971497
Zimmer ActivBraid Rotator Cuff Repair (RCR) Study
Conditions: Rotator Cuff Repair of the Shoulder
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 65
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06971497). StuddyBuddy aggregates publicly available trial information.