Clinical Trial

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Recruiting Phase 4
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Summary
The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-06-27; most recent amendment 2026-02-24.
Status change: Not Yet Recruiting → Recruiting 2022-10-17
Trial Details
NCT Number NCT05439850
Lead Sponsor Henry Ford Health System
Conditions Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
Enrollment 78 participants
Start Date 2022-08-16
Primary Completion 2028-07-01 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-27