Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures

Study Overview
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Brief Summary
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Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty. The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.

Official Title
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Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures in Patients Older Than 70 Years. A Multicenter Randomized Controlled Trial

Conditions
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Humeral Fracture, Proximal

Intervention / Treatment
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* Procedure: Reverse Total Shoulder Arthroplasty
* Procedure: Hemiarthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Displaced 3- or 4-part fracture of the proximal humerus Age over 70 years Independent living Low energy trauma Exclusion criteria Pre-existing shoulder disease Severe cognitive dysfunction More than 14 days from injury to surgery Comorbidity that affects shoulder rehabilitation considerably Concurrent injury that affect shoulder rehabilitation considerably

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reverse Total Shoulder Arthroplasty<br> | Procedure: Reverse Total Shoulder Arthroplasty<br> <br> |
| Active Comparator: Hemiarthroplasty<br> | Procedure: Hemiarthroplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Score | The Constant-Murley score is used to assess shoulder function. The maximum score is 100 points. Higher scores represent better shoulder function. | 24 months | 
| WOOS (Western Ontario Osteoarthritis of the Shoulder) Index |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humeral Fracture, Proximal, Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty, Shoulder Hemiarthroplasty