Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

Study Overview
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Brief Summary
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Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

Detailed Description
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The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.

Official Title
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Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Device: External rotation shoulder sling
* Device: Internal rotation shoulder sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 14 to 30 years of age Willing to participate in follow-up for at least two years Acute, first-time, traumatic, isolated anterior dislocation of the shoulder Exclusion Criteria: Previous instability of the affected shoulder A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments Incompetent or unwilling to consent A medical condition making the patient unable to wear a sling Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%) Neurovascular compromise of the affected limb Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.

Ages Eligible for Study
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Minimum Age: 14 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: External rotation shoulder sling<br>External rotation shoulder sling | Device: External rotation shoulder sling<br>* The external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder.<br>|
| Active Comparator: Internal rotation shoulder sling<br>Internal rotation shoulder sling | Device: Internal rotation shoulder sling<br>* The internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self reported outcome measures |  | 24 Months | 
| Time to return to work or sport |  | 24 Months |