Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

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 randomization and receive an Magnetic Resonant Imaging (MRI) scan 12 months after surgery. The primary outcome measure is to assess the Re-tear rate of rotator cuff at 12 months after surgery. The secondary outcome measure is to assess functional scores of the shoulder at 12 months . The tertiary outcome measures are to check the cost effectiveness of each procedure.

Inclusion criteria

• Patient aged at least 50 years to 75 years.
• Degenerative cuff tear.
• Large Full thickness rotator cuff tear (≥ 3cm and < 5 cm ) that is fully repairable.
• Tears diagnosed using MRI scan.
• Ability to consent.
• Agreement to use of human dermal matrix allograft as augmentative patch

Exclusion criteria

• Previous surgery on the affected shoulder.
• Osteoarthritic changes.
• Unable to have MRI Scans.
• Significant neck pathology.
• Cognitive problems or language issue.
• Systemic arthritis
• Significant dual pathology in the involved shoulder
• Acute Traumatic tears (< 6 months since injury).