Rotator Cuff TearsPhase 4CUFFPATCHNCT04975581
Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation
A Phase 4 study testing Allograft Patch in people with Rotator Cuff Tears, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Allograft Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2021to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hopsitals of Leicester NHS Trust
Leicester
UHL Sponsor, +44 116 258 8239(1823)
About this study
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.
Read the detailed 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Allograft Patch
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allograft PatchBiological
Rotator Cuff repair with Allograft Patch (Graftjacket Now)
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff repair Surgery with Augmentative patch | Experimental | Open rotator cuff repair Surgery with additional application of augmentative human allograft patch Receives: Biological: Allograft Patch |
| Rotator cuff repair surgery | Active comparator | Open Rotator cuff repair surgery Receives: Biological: Allograft Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retear on MRI scan
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start3 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975581
- Sponsor's protocol ID
- EDGE ID 139197
- Acronym
- CUFFPATCH
- Status last verified
- May 2026
- First submitted
- 6 May 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation
- ClinicalTrials.gov ID
- NCT04975581
- Acronym / sponsor ID
- CUFFPATCH / EDGE ID 139197
- Conditions
- Rotator Cuff Tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff repair Surgery with Augmentative patch | Experimental | Biological: Allograft PatchOpen rotator cuff repair Surgery with additional application of augmentative human allograft patch |
| Rotator cuff repair surgery | Active comparator | Biological: Allograft PatchOpen Rotator cuff repair surgery |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Previous surgery on the affected shoulder.
- Osteoarthritic changes.
- Unable to have MRI Scans.
- Significant neck pathology.
- Cognitive problems or language issue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allograft PatchRotator Cuff repair with Allograft Patch (Graftjacket Now) | Biological | Rotator cuff repair Surgery with Augmentative patch, Rotator cuff repair surgery |
Primary outcome
Retear on MRI scan
Time frame: 12-18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
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Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
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Not yet recruiting
Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allograft Patch in people with Rotator Cuff Tears, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UHL Sponsor (+44 116 258 8239 (1823), uhlsponsor@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retear on MRI scan (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.