BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears (NCT05997381) | Clinical Trial Compass
RecruitingNot Applicable
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
United States268 participantsStarted 2024-01-05
Plain-language summary
This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.
Who can participate
Age range40 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female 40 to 70 years old
✓. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):
✓. Tear of the supraspinatus and/or infraspinatus tendons
✓. Tear size ≥ 2 cm and \< 5 cm
✓. Chronic shoulder pain ≥ 3 months
✓. Failed non-operative treatment of the index shoulder to include one or all of the following:
✕. Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
✕. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)