Actively Recruiting
Patch Study (Patch-augmented Rotator Cuff Repair)
Led by Spital Thurgau AG · Updated on 2023-10-11
300
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Patch Study (Patch-augmented Rotator Cuff Repair)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Spital Thurgau AG
Frauenfeld, Thurgau, Switzerland, 8501
Actively Recruiting
Research Team
F
Florian Hess, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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