Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

Study Overview
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Brief Summary
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Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of 1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed by an immobilization of the arm. The purpose of the study is to evaluate the healing of the labrum in first time anterior glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an external rotation brace to an internal rotation brace to immobilize the injured arm.

Official Title
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First Time Anterior Glenohumeral Joint Dislocation With a Bankart Lesion in Young Patients: Which Type of Immobilization Should be Chosen? A Prospective Randomized Study

Conditions
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Glenohumeral Joint Dislocation

Intervention / Treatment
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* Device: Donjoy ER brace
* Device: Thoraco brachial brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years old < 40 years old anterior glenohumeral joint dislocation proved by radiography dislocation needing a reduction manoeuvre home close to evaluation site for 24 months follow-up visits signed consent form Exclusion Criteria: associated fracture Hill-Sachs lesion = or > than 30% neurovascular deficit hypermobility pre-existing instability of the injured shoulder systemic neurological disease allergy to gadolinium functional sequel to the shoulder due to previous injury incapacitated adult patient minor patient home far from evaluation site refusal to sign the consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: external rotation immobilization<br>Patient will wear an external rotation brace to immobilize the injured arm. | Device: Donjoy ER brace<br>* Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.<br>|
| Active Comparator: internal rotation immobilization<br>Patient will wear an internal rotation brace to immobilize the injured arm. | Device: Thoraco brachial brace<br>* Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical healing of the labrum | An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum. | 3 months after dislocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in relapse rate | Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position | 3 months after dislocation | 
| Decrease in relapse rate | Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position | 12 months after dislocation | 
| Decrease in relapse rate | Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position | 24 months after dislocation |