Bioinductive patch for repairing rotator cuff tears
Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
PHASE4 · Henry Ford Health System · NCT05439850
This study is testing if adding a special patch during surgery can help people with rotator cuff tears heal better than just standard surgery alone.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System (other) |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05439850 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic, full-thickness rotator cuff tears who have not responded to conservative treatment.
Not a fit: Patients with partial-thickness tears, small tears, or those with acute injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve healing rates and outcomes for patients with rotator cuff tears.
How similar studies have performed: Other studies have shown promise with bioinductive implants in tendon repair, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Detroit, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Rotator Cuff Tear, Bioinductive, Arthroscopic Rotator Cuff Repair