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Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
N/A
Waitlist Available
Led By Joaquin Sanchez-Sotelo, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up base line to 2 years
Awards & highlights
No Placebo-Only Group
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)?
Eligible Conditions
- Shoulder Fracture
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ base line to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~base line to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To measure the change using the chi-square tests for lowering the pain score of the patients
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Open Reduction Internal Fixation Proximal HumerusActive Control1 Intervention
The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate.
Group II: Reverse Total Shoulder ArthroplastyActive Control1 Intervention
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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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,121 Total Patients Enrolled
Joaquin Sanchez-Sotelo, MD, PhDPrincipal InvestigatorMayo Clinic