Status:
RECRUITING
Patch Study (Patch-augmented Rotator Cuff Repair)
Lead Sponsor:
Spital Thurgau AG
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
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 cuf...
Detailed Description
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 cuf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06076902
Start Date
April 6 2023
End Date
April 30 2027
Last Update
October 11 2023
Active Locations (1)
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1
Spital Thurgau AG
Frauenfeld, Thurgau, Switzerland, 8501