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Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

RecruitingPhase 4Ages 50 Years - 75 YearsAllUniversity Hospitals, Leicester
NCT04975581 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The Investigators are planning to conduct a Pilot study of 40 patients of Pragmatic randomised controlled trial comparing rotator cuff tendons repair (small tendons around the shoulder ) with or without augmentative patch. It includes patients between age groups 50 to 75 years with large (≥ 3cm and \< 5 cm ) rotator cuff tear that can be fully repaired using open or mini open repair with or without an augmentation with a human dermal matrix allograft (processed skin graft from a human donor ). The main aim is to examine whether the addition of the patch helps to reduce the rate of re-tear of the rotator cuff tendons at one year following surgery. Patients are randomized to receive either a repair with addition of an augmentative patch or a repair without a patch and have an identical follow-up after surgery. Patients are followed up in outpatient at 6 weeks , 3 months and 12 months after

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📋 Eligibility rules (as published)
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).
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What it tests

  • Allograft Patch
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Where

1 site
University Hopsitals of Leicester NHS Trust
Leicester, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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