None listed
Conditions
Brief summary
To compare whether use of a dermal allopatch graft in rotator cuff repair leads to improved functional and structural outcomes over a 2-year period compared to no graft. It is expected the use of these grafts will improve functional shoulder outcomes and reduce the re-tear rate following surgery. If successful these grafts can be potentially considered a gold standard of care moving forward. We will also be monitoring for any changes in adverse event profile.
Interventions
Use of an allopatch augmentation graft by an consultant orthopaedic surgeon in surgical rotator cuff repair. The graft is an acellular dermal allopatch graft that has been treated and suitable for surgery. It theoretically provides a mechanical bridge to aid in the strength of the repair. This will occur as an additional step during an arthroscopic repair of the rotator cuff at a certified hospital to repair the rotator cuff that adds roughly an extra 20 minutes and overall takes 1.5-2h to compl
Use of an allopatch augmentation graft by an consultant orthopaedic surgeon in surgical rotator cuff repair. The graft is an acellular dermal allopatch graft that has been treated and suitable for surgery. It theoretically provides a mechanical bridge to aid in the strength of the repair. This will occur as an additional step during an arthroscopic repair of the rotator cuff at a certified hospital to repair the rotator cuff that adds roughly an extra 20 minutes and overall takes 1.5-2h to complete the surgery.
Sponsors
St. John of God Healthcare Subiaco
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Diagnosis of rotator cuff tear confirmed radiologically by MRI to be full-thickness, greater than or equal to 4cm, involve two or more tendons and be repairable. - Adequate pre-operative function of the uninjured arm. - Ability to understand and participate in the trial including ability to understand and complete the patient reported outcome measures (PROMs). - Ability to participate in regular rehabilitation post-operatively. - Age 18-75 years. - Medically fit for surgery with general anaesthetic.
Exclusion criteria
Age less than 18 years or greater than 75 years. - Any previous surgical repair to the injured shoulder - Neuromuscular disorders (for example, myasthenia gravis, Lambert-Eaton, amyotrophic lateral sclerosis et cetera). - Upper extremity dysfunction due to a neurological or medical cause (for example, due to a cerebrovascular accident or traumatic brain injury, diabetic neuropathy et cetera). - Unfit for general anaesthesia. - Evidence of active infection or cancer. - Current smoker. - Current use of immunosuppressing medication.
Outcome results
None listed