At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Allograft Patch (biological)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Allograft Patch — biological: Rotator Cuff repair with Allograft Patch (Graftjacket Now)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 50 Years to 75 Years
- Who
- All
- Number of participants
- 40
- Started
- 2021-12-03
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for rotator cuff tears
- • Phase4 - 40 participants
- • 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
Who can take part?
- • Ages 50 Years to 75 Years
- • Diagnosed with rotator cuff tears
Where?
- • Leicester - University Hopsitals of Leicester NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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 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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓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.
Who cannot take part
- ✗Previous surgery on the affected shoulder.
- ✗Osteoarthritic changes.
- ✗Unable to have MRI Scans.
- ✗Significant neck pathology.
- ✗Cognitive problems or language issue.
See the full criteria
Where Is This Study? (1 UK site)
University Hopsitals of Leicester NHS Trust
Leicester, United Kingdom
How to Get in Touch
UHL Sponsor
Sponsor contactCONTACT