Immobilization in External Rotation of Acute Shoulder Dislocations

Study Overview
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Brief Summary
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The purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24 months.

Detailed Description
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Immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation)should reduce the rate of recurrent dislocations experienced in 24 months.

Official Title
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A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder

Conditions
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Anterior Shoulder Dislocation

Intervention / Treatment
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* Device: Immobilization in External Rotation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: skeletally mature patients less than 30 years of age sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. Mechanism of abduction, external rotation ii. Sudden pain in the shoulder iii. Manipulative reduction required or iv. Radiograph documenting a dislocated joint willing to participate in follow-up for at least two years Exclusion Criteria: incompetent or unwilling to consent inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments previous instability of the affected shoulder significant associated fracture (exception Hill Sachs or Bankart lesions) concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder neurovascular compromise of the affected limb a medical condition making the patient unable to wear a brace or sling

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 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 |
| --- | --- |
| Experimental: exernal rotation<br>external rotation at 90 degrees | Device: Immobilization in External Rotation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Instability at 24 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (weeks) to return to work and time(weeks) to return to sport |  |  | 
| Complications (resulting from immobilization) |  |  | 
| Compliance with immobilization protocol |  |  | 
| Western Ontario Shoulder Instability index (WOSI) |  |  | 
| American Shoulder and Elbow Surgeons questionnaire (ASES) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immobilization in External Rotation, Acute primary anterior shoulder dislocation