Placental-derived tissue patch to help rotator cuff repair
Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation
The trial will test whether adding a decellularized human placental tissue patch at the repair site improves healing after full-thickness rotator cuff repair in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07027735 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study will assign half of enrolled adults undergoing primary full-thickness rotator cuff repair to receive a decellularized human placental extracellular matrix patch at the tendon-to-bone interface and half to standard repair without augmentation. The placental-derived scaffold is cell-free and is intended to encourage native cell ingrowth and recreate the tendon-to-bone transition zone to reduce scar formation and bone resorption. Outcomes will include imaging and clinical measures of tendon healing and function over the postoperative period. Key eligibility limits enrollment to primary full-thickness tears and excludes partial tears, full-thickness subscapularis tears, high-grade fatty degeneration (Goutallier 3–4), and prior rotator cuff surgery.
Who should consider this trial
Good fit: Adults (≥18 years) with a diagnosed full-thickness rotator cuff tear who are scheduled for primary repair and do not have severe fatty degeneration or prior rotator cuff surgery.
Not a fit: Patients with partial-thickness tears, full-thickness subscapularis tears, advanced fatty infiltration (Goutallier grade 3–4), or prior rotator cuff surgery are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the patch could increase tendon-to-bone healing and lower retear rates after rotator cuff repair.
How similar studies have performed: Animal studies and small human series have reported improved remodeling and healing with decellularized extracellular matrix patches, but large randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of full thickness rotator cuff tear Exclusion Criteria: * Partial thickness tears * Full thickness subscapularis tears * Goutallier grades 3 and 4 * Prior rotator cuff surgery
Where this trial is running
New York, New York
- NewYorkPresbyterian Hospital @ Columbia — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: William Levine, MD — Columbia University
- Study coordinator: Andrew J Luzzi, MD
- Email: al3896@cumc.columbia.edu
- Phone: 18604595700
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.