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Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Sponsor: Henry Ford Health System
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.
Official title: Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2022-08-16
Completion Date
2029-07-01
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
arthroscopic rotator cuff repair
This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.
Bioinductive implant
A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.
Ultrasound Imaging
An ultrasound will be performed on each patient one year postoperatively.
Locations (1)
Henry Ford Health
Detroit, Michigan, United States