Actively Recruiting
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Led by Henry Ford Health System · Updated on 2026-02-27
78
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for arthroscopic rotator cuff repair surgery
- Diagnosed with full-thickness medium (1-3 cm), large (3-5 cm), or massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons confirmed by MRI or ultrasound
- Have chronic, degenerative rotator cuff tears
- Able to read and understand English
- At least 18 years old
- Failed at least 6 weeks of conservative treatment including in-person physical therapy or documented home therapy
You will not qualify if you...
- Scheduled for open or mini-open rotator cuff repair
- Prior surgery on the affected shoulder except diagnostic arthroscopy
- Partial-thickness rotator cuff tears
- Small rotator cuff tears (<1 cm)
- Rotator cuff tears involving the subscapularis tendon
- Acute and traumatic rotator cuff tears
- Active infection
- Cancer
- Autoimmune or rheumatologic disorders including rheumatoid arthritis, psoriatic arthritis, or systemic lupus erythematosus
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
J
Johnny Kasto, MD
CONTACT
S
Stephanie J Muh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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