Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation
Recruiting
Phase 4
Interventional Study
Rotator Cuff Tears
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 75
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- University Hospitals, Leicester · Other
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About This Trial
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 withou…
Trial Locations
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Eligibility 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 au…
Contacts