Bioinductive patch for repairing rotator cuff tears

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized-controlled study aims to compare the outcomes of arthroscopic rotator cuff repair with and without a bioinductive implant. Patients with full-thickness rotator cuff tears who have failed conservative treatment for at least six weeks will be randomly assigned to either the control group receiving standard surgery or the experimental group receiving surgery augmented with the bioinductive patch. The primary outcome will be assessed through ultrasound imaging to determine the integrity of the rotator cuff repair one year postoperatively. The hypothesis is that the bioinductive patch will enhance healing and repair integrity compared to standard repair alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Henry Ford Health
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: Stephanie J Muh, MC — Henry Ford Health
• Study coordinator: Johnny Kasto, MD
• Email: jkasto1@hfhs.org
• Phone: 313-244-8078

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.