An interventional study of Fracture repair and Fracture repair with joint replacement in Closed Fracture Proximal Humerus, Four Part, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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)?
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's enrollment of 3 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Exclusion
The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate.
Procedure: Fracture repair
The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty.
Procedure: Fracture repair with joint replacement
To measure the change using the chi-square tests for lowering the pain score of the patients
threshold of statistical significance will be set at α = 0.05.
Time frame: base line to 2 years
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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