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project opened under new PI
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Reduction Internal Fixation Proximal Humerus | Active Comparator | The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate. |
|
| Reverse Total Shoulder Arthroplasty | Active Comparator | The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fracture repair | Procedure |
| ||
| Fracture repair with joint replacement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | base line to 2 years |
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin Sanchez-Sotelo, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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| Procedure |
|
| D019919 | Prosthesis Implantation |