Shoulder patch passes safety check in ongoing study
NCT ID NCT05906004
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study is checking the long-term safety and how well a medical device called the Pitch-Patch works for people who have had surgery for a torn rotator cuff in the shoulder. The Pitch-Patch is a small polyester patch that helps strengthen the repair. About 37 people who already received the patch 2 to 2.5 years ago will be followed for up to 3 years to see how their shoulder function changes and if any problems occur.
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.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Rotator cuff tear treated with Pitch-Patch for augmentation or reinforcement of the rotator cuff.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patient has been treated using a Pitch-Patch device for augmentation or reinforcement of the rotator cuff 2-2.5years prior to enrolment. * Patient has a baseline Constant Murley Score (CMS), assessed within 30 days prior to implantation of the device. * Patient must be 16 years old or above. * Patient is willing to participate in the study, and having been informed of the nature of the study, has provided written informed consent as approved by the Ethics Committee (EC). Exclusion Criteria: \- The Pitch-Patch has been used outside its intended use.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Reading Shoulder Unit
RECRUITINGReading, RG1 6UZ, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Brain signals and resilience: the hidden side of rotator cuff recovery
- Can a Stomach-Derived peptide help tendons heal faster after surgery?
- Can a patch make torn shoulder tendons heal stronger?
- Blood-derived injections may mend torn shoulder tendons without surgery
- MRI and biomarkers may predict rotator cuff repair success
- Ultrasound 'Tissue Stiffness' test could reveal hidden rotator cuff healing problems