Status:
UNKNOWN
A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Lead Sponsor:
Signe Rosner Rasmussen
Collaborating Sponsors:
Herlev and Gentofte Hospital
Conditions:
Shoulder Fractures
Eligibility:
All Genders
65-120 years
Phase:
NA
Brief Summary
The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compare...
Eligibility Criteria
Inclusion
- Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
- Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
- All patients, regardless of age, with an insufficient or irreparable rotator cuff
Exclusion
- Brachial plexus palsy
- Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
- Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
- Patients without a Danish civil registration number
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04507880
Start Date
August 1 2020
End Date
August 1 2024
Last Update
August 11 2020
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