Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

Not Applicable

Completed

• Conditions: Shoulder Dislocation
• Interventions: Device: External rotation shoulder sling; Device: Internal rotation shoulder sling

• Registration Number: NCT00707018
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

Detailed Description

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External rotation shoulder sling	External rotation shoulder sling	External rotation shoulder sling
Internal rotation shoulder sling	Internal rotation shoulder sling	Internal rotation shoulder sling

Primary Outcome Measures

Name	Time	Method
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.	24 months

Secondary Outcome Measures

Name	Time	Method
Patient self reported outcome measures	24 Months
Time to return to work or sport	24 Months

Trial Locations

Locations (8)

St. Anthony Hospitals; 🇺🇸 Winter Park, Colorado, United States

CU Sports Medicine; 🇺🇸 Boulder, Colorado, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Summa Healthcare; 🇺🇸 Akron, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Inland Orthopaedics; 🇺🇸 Pullman, Washington, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States