Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

Study Overview
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Brief Summary
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The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

Detailed Description
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The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18). Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty. The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.

Official Title
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Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

Conditions
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Humeral Fracture, Aged Patient, Reversed Total Shoulder Arthroplasty, Surgical Approach

Intervention / Treatment
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* Procedure: Reversed total shoulder arthroplasty
* Procedure: lateral approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated) Patient registered to the national health system Patient able to understand information about the protocol and answer to questionnaire Exclusion Criteria: Non-displaced fracture or no need of surgical treatment. Existing bone disease Infection Neurological deficit (axillary nerve) Multi-injured patients Patient no able to fulfill the questionnaire Patient refuses the study

Ages Eligible for Study
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Minimum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: deltopectoral approach<br>the patients are treated with deltopectoral approach surgery | Procedure: Reversed total shoulder arthroplasty<br>* Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach<br>|
| Other: lateral approach<br>the patients are treated with a lateral approach surgery | Procedure: lateral approach<br>* Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Murley Score | Constant Murley Score it a clinical method of functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick dash score | the Quick Dash score is a functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score | 3, 6 and 12 months | 
| SF12 score | The SF12 score is a quality of life assessment. The score varies between 0 and 100, more the value is better brought up is the score | 3, 6 and 12 months | 
| Alder score | Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score | 3, 6 and 12 months | 
| The Simple Shoulder Test (SST) | The Simple Shoulder Test is functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score | 3, 6 and 12 months | 
| WOOS (The Western Ontario Osteosarthritis ) | The Western Ontario Osteosarthritis of the shoulder index is a quality of life measurement tool for osteoarthritis of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score | 3, 6 and 12 months | 
| intensity of pain | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between  no pain  (the score of 0) and  the pain so badly as he could be  or  the worst conceivable pain  (the score of 10) | pre op, 3, 6 and 12 months | 
| Radiologic evaluation | Radiologic evaluation | pre op, 3, 6 and 12 months | 
| Complications | list of the complications | pre op, 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective, Randomized study, Proximal humerus fracture, Surgical treatment