Repairing rotator cuff tears with or without a dermal patch
Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation
This study is testing whether using a special dermal patch during rotator cuff surgery helps people aged 50 to 75 heal better than traditional repair methods.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT04975581 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare the effectiveness of repairing large rotator cuff tears using traditional methods versus methods that include an augmentative human dermal matrix patch. It will involve 40 patients aged 50 to 75 years with specific criteria for rotator cuff tears. Participants will be randomly assigned to receive either the standard repair or the repair with the dermal patch, followed by outpatient evaluations at 6 weeks, 3 months, and 12 months post-surgery, including MRI scans to assess re-tear rates. The study will also evaluate shoulder function and cost-effectiveness of the two approaches.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 75 years with large, degenerative rotator cuff tears that can be fully repaired.
Not a fit: Patients with previous shoulder surgeries, acute traumatic tears, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced rates of re-tear for patients with rotator cuff injuries.
How similar studies have performed: While similar approaches have been explored, this specific combination of techniques is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient aged at least 50 years to 75 years. 2. Degenerative cuff tear. 3. Large Full thickness rotator cuff tear (≥ 3cm and \< 5 cm ) that is fully repairable. 4. Tears diagnosed using MRI scan. 5. Ability to consent. 6. Agreement to use of human dermal matrix allograft as augmentative patch Exclusion Criteria: 1. Previous surgery on the affected shoulder. 2. Osteoarthritic changes. 3. Unable to have MRI Scans. 4. Significant neck pathology. 5. Cognitive problems or language issue. 6. Systemic arthritis 7. Significant dual pathology in the involved shoulder 8. Acute Traumatic tears (\< 6 months since injury).
Where this trial is running
Leicester
- University Hopsitals of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: UHL Sponsor
- Email: uhlsponsor@uhl-tr.nhs.uk
- Phone: +44 116 258 8239 (1823)
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.