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New treatment option for Rotator Cuff Tears
Official title Patch Study (Patch-augmented Rotator Cuff Repair)
ClinicalTrials.gov ID: NCT06076902
What this study is testing
- What it's testing
- This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Frauenfeld, Thurgau, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frauenfeld, Thurgau, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.