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Can a donor skin patch stop rotator cuff tears from coming back?

NCT ID NCT04975581

Disease control Sponsor: University Hospitals, Leicester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a patch made from donated human skin to standard rotator cuff repair surgery can lower the chance of the tendon tearing again. Forty adults aged 50 to 75 with large tears will be randomly assigned to get surgery with or without the patch. An MRI one year later will check for re-tears.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human dermal matrix allograft (processed skin graft from a human donor)
What this could lead to
If it works, this could reduce the chance of rotator cuff re-tear after surgery, improving shoulder function and avoiding repeat operations.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to everyone. The patch is from human donors, which carries a small risk of infection or rejection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged at least 50 years to 75 years. 2. Degenerative cuff tear. 3. Large Full thickness rotator cuff tear (≥ 3cm and \< 5 cm ) that is fully repairable. 4. Tears diagnosed using MRI scan. 5. Ability to consent. 6. Agreement to use of human dermal matrix allograft as augmentative patch Exclusion Criteria: 1. Previous surgery on the affected shoulder. 2. Osteoarthritic changes. 3. Unable to have MRI Scans. 4. Significant neck pathology. 5. Cognitive problems or language issue. 6. Systemic arthritis 7. Significant dual pathology in the involved shoulder 8. Acute Traumatic tears (\< 6 months since injury).

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rotator cuff tears

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hopsitals of Leicester NHS Trust

    RECRUITING

    Leicester, United Kingdom

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