Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation (CUFFPATCH)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
UHL Sponsor
Data sourced from clinicaltrials.gov
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