Comparing two methods for repairing rotator cuff tears
Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Spital Thurgau AG Academic / other |
| Locations | 1 site (Frauenfeld, Thurgau) |
| Trial ID | NCT06076902 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe fatty infiltration, bilateral tears, or significant arthritis may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Frauenfeld, Thurgau
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.