Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Launched by HENRY FORD HEALTH SYSTEM · Jun 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with full-thickness rotator cuff tears, which are injuries to the shoulder that can cause pain and limit movement. The trial aims to compare two approaches: one group will receive a standard surgical repair, while the other group will receive the same repair but with an added Bioinductive Implant, which is designed to help the shoulder heal better. Researchers want to see if using the implant leads to stronger repairs one year after surgery, as measured by ultrasound.

To participate in this study, individuals must be at least 18 years old and have specific types of rotator cuff tears that haven’t improved with at least six weeks of physical therapy. The trial is open to both men and women, and it is currently recruiting participants. Those who join can expect to undergo a minimally invasive surgery and will be monitored over the next year to assess the success of their repair. It's important to note that not everyone will qualify; for example, people with certain shoulder conditions or other health issues may be excluded from the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Indicated and scheduled for arthroscopic rotator cuff repair.
• • Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
• • Chronic, degenerative rotator cuff tears.
• • Ability to read and understand English.
• • Age ≥18 years
• • Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy
• Exclusion Criteria:
• • Patient scheduled for open or mini-open rotator cuff repair
• • Prior surgery of affected shoulder (except diagnostic arthroscopy)
• • Partial-thickness rotator cuff tears
• • Small (\<1 cm) rotator cuff tears
• • Rotator cuff 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