Can a patch make torn shoulder tendons heal stronger?
NCT ID NCT07005063
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests a device called the FiberLocker System, which includes a patch that surgeons attach to a torn rotator cuff tendon during repair surgery. The patch is meant to reinforce the repair and help it hold. Researchers will follow about 50 adults aged 40 to 65 who need surgery for a full-thickness rotator cuff tear. The main goal is to check safety by tracking complications over 12 months, and to see if the patch lowers the chance of the tendon tearing again.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FiberLocker System, a device with a PET patch and an instrument that anchors the patch into the tendon during rotator cuff repair surgery
- What this could lead to
- If it works, this could lead to a stronger rotator cuff repair that is less likely to tear again, improving recovery and shoulder function.
- What could go wrong
- This is a small pilot study, so results may not apply to everyone. The patch could cause complications, and it is not yet clear if it reduces retears better than standard surgery alone.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 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.
- Ages
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40 to 65 years
- 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: 1. Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure 2. Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus 3. The rotator cuff tear is of traumatic origin. 4. Subject is ≥ 40 years of age \& ≤ 65 years of age. 5. Primary rotator cuff repair 6. Informed Consent signed by the subject 7. Pre-operative MRI performed Exclusion Criteria: 1. Vulnerable subjects (as defined in ISO 14155) 2. Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate 3. Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation, 4. Previous enrolment into the current investigation, 5. Enrolment of the PI, his/her family members, employees and other dependent persons, 6. Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject 7. Active smoker 8. History of claustrophobia that would prevent an MRI of the index shoulder 9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder 10. Pregnant or planning to become pregnant during the study period 11. Breast feeding women 12. Subject has conditions or circumstances that would interfere with study requirements. 13. Contraindications and limitations of the MD as described in the IFUs. 14. Partial rotator cuff tears 15. History or known allergy or intolerance to polyester 16. Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater 17. Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear 18. Limited space or exposure for implant delivery 19. Structural or pathological condition of the bone or soft tissue that could impair healing. 20. Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria 21. Fatty infiltration of the index shoulder rotator cuff muscle \> Goutallier Score 2 22. Corticosteroid injection in the operative shoulder within 6 weeks of operation 23. Subject shows frozen shoulder/adhesive capsulitis at day of surgery 24. Cases of moderate to severe osteoarthritis 25. Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy) 26. Subjects with diabetes type I or II 27. The subject currently has an acute infection in the area surrounding the surgical site 28. Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint. 29. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
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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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Balgrist University Hospital
RECRUITINGZurich, Canton of Zurich, 8008, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood-derived injections may mend torn shoulder tendons without surgery
- Ultrasound 'Tissue Stiffness' test could reveal hidden rotator cuff healing problems
- Which painkiller wins for shoulder surgery? a Head-to-Head test
- Could a nasal spray shield aging brains from Post-Surgery confusion?
- Which shoulder repair works best for massive tears? a trial pits two techniques Head-to-Head