Repairing rotator cuff tears with or without a dermal patch
Official title: Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation
Run by University Hospitals, Leicester · NCT04975581 · Data updated 2026-11-12
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 |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Status | Recruiting |
| Started | December 3, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT04975581 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50 to 75 years with large, degenerative rotator cuff tears that can be fully repaired.
✕Probably not a fit
Patients with previous shoulder surgeries, acute traumatic tears, or significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar approaches have been explored, this specific combination of techniques is relatively novel and has not been extensively tested.
Who can join: the full rules
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 it's running
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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)
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
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Biomarkers to see if rotator cuff repairs will heal after surgery
This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.
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Mobilization with Movement for people with rotator cuff lesions
This trial will test whether Mobilization with Movement helps reduce pain, improve shoulder function, and restore joint position sense in adults with rotator cuff lesions.
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Does age-related muscle loss change rotator cuff tear patterns?
We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.
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Impact of neck nerve compression (cervical radiculopathy) on recovery after rotator cuff repair
This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.
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Using virtual reality to help rehabilitate shoulder injuries
This study tests whether using virtual reality can make shoulder rehabilitation more engaging and effective for people with shoulder injuries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.