Actively Recruiting
Arthroscopic Rotator Cuff Repair with Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
Led by Henry Ford Health System · Updated on 2026-02-27
78
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of arthroscopic rotator cuff repair surgery for patients with full-thickness rotator cuff tears. This study compares the standard surgery to the same surgery augmented with a Bioinductive Implant, which is a patch designed to promote tendon healing. The main focus is to see if the implant improves the repair's integrity one year after surgery, as shown by ultrasound imaging. Participants will be randomly assigned to one of two groups. One group will receive the standard arthroscopic rotator cuff repair surgery alone, while the other group will have the same surgery plus the bioinductive patch implanted during the procedure. Both groups will be followed up with ultrasound imaging one year after surgery to assess the repair's condition. During the study, participants will undergo evaluations including ultrasound imaging one year after surgery to check repair integrity. Additional assessments will track upper extremity function, pain interference, depression, shoulder range of motion, strength, complications, and any need for reoperation for up to two years after surgery. The total participation duration includes preoperative assessments through two years postoperatively to monitor healing and outcomes.
CONDITIONS
Brief Title
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indicated and scheduled for arthroscopic rotator cuff repair
- Full-thickness medium (1-3 cm), large (3-5 cm), or massive (>5 cm) rotator cuff tears involving supraspinatus and/or infraspinatus tendons diagnosed by MRI or ultrasound
- Chronic, degenerative rotator cuff tears
- Ability to read and understand English
- Age 18 years or older
- Failed at least 6 weeks of conservative treatment including structured physical therapy or documented home therapy
You will not qualify if you...
- Scheduled for open or mini-open rotator cuff repair
- Prior surgery on affected shoulder except diagnostic arthroscopy
- Partial-thickness rotator cuff tears
- Small (<1 cm) rotator cuff tears
- Tears involving the subscapularis tendon
- Acute and traumatic rotator cuff tears
- Active infection
- Cancer
- Autoimmune and rheumatologic disorders including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo arthroscopic rotator cuff repair surgery. Those in the experimental group receive an additional bioinductive patch implant during surgery.
1 surgical visit (in-person)
Duration - Up to 2 years post-surgery
Participants have follow-up visits including ultrasound imaging to assess tendon healing and recovery.
Ultrasound imaging at 1 year postoperatively and additional visits up to 2 years
Trial Site Locations
Total: 1 location
1
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
J
Johnny Kasto, MD
S
Stephanie J Muh, MD
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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