Comparing two methods for repairing rotator cuff tears
Official title: Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair
Run by Spital Thurgau AG · NCT06076902 · Data updated 2026-11-12
This study is testing whether using a synthetic patch during rotator cuff surgery helps people heal better and reduces the chance of their tear coming back compared to standard surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 75 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Spital Thurgau AG Academic / other |
| Locations | 1 site (Frauenfeld, Thurgau) |
| Status | Recruiting |
| Started | April 6, 2023 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | October 11, 2023 |
| Trial ID | NCT06076902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with massive rotator cuff tears affecting at least two tendons, who are German-speaking and eligible for primary surgery.
✕Probably not a fit
Patients with severe fatty infiltration, bilateral tears, or significant arthritis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized controlled study will evaluate the effectiveness of arthroscopic rotator cuff reconstruction with and without the use of a synthetic polyester patch. Patients will be randomly assigned to one of two treatment groups: one receiving patch augmentation and the other receiving standard fixation with anchors. The primary focus is on comparing retear rates, while secondary outcomes will include mid- and long-term clinical and radiological assessments using established orthopedic evaluation tools. The study will follow patients for two years post-surgery to gather comprehensive data on their recovery.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced retear rates for patients with rotator cuff tears.
How similar studies have gone: While similar studies have explored rotator cuff repair techniques, the specific use of this synthetic patch augmentation is a novel approach that has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with massive rotator cuff tear * Tear must affect at least two tendons * Primary surgery only * Origin of tear can be either degenerative or traumatic * German language speaking Exclusion Criteria: * Fatty infiltration grade 4 (according to Goutallier) * Bilateral tears * Cases of arthritis or severe osteoarthritis * Structural or pathological condition of the bone or soft tissue that could impair healing * Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines * Unable or unwilling to give consent (language barrier or cognitive impairment) * Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits
Where it's running
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Spital Thurgau AG
Frauenfeld, Thurgau, Switzerland Recruiting
Study contacts
- Principal investigator: Florian Hess, MD — Spital Thurgau AG
- Study coordinator: Florian Hess, MD
- Email: florian.hess@stgag.ch
- Phone: +41 58 144 8143
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
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Biomarkers to see if rotator cuff repairs will heal after surgery
This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.
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We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.
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This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.