Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
Not Applicable
Terminated
- Conditions
- Closed Fracture Proximal Humerus, Four Part
- Interventions
- Procedure: Fracture repair with joint replacementProcedure: Fracture repair
- Registration Number
- NCT02597972
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?
- Detailed Description
The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reverse Total Shoulder Arthroplasty Fracture repair with joint replacement The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty. Open Reduction Internal Fixation Proximal Humerus Fracture repair The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate.
- Primary Outcome Measures
Name Time Method To measure the change using the chi-square tests for lowering the pain score of the patients base line to 2 years threshold of statistical significance will be set at α = 0.05.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States