Immobilization in External Rotation of Acute Shoulder Dislocations

Phase 3

Completed

• Conditions: Anterior Shoulder Dislocation
• Interventions: Device: Immobilization in External Rotation

• Registration Number: NCT00196560
• Lead Sponsor: Fowler Kennedy Sport Medicine Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-26
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exernal rotation	Immobilization in External Rotation	external rotation at 90 degrees

Primary Outcome Measures

Name	Time	Method
Recurrent Instability at 24 months

Secondary Outcome Measures

Name	Time	Method
Western Ontario Shoulder Instability index (WOSI)
Complications (resulting from immobilization)
Compliance with immobilization protocol
American Shoulder and Elbow Surgeons questionnaire (ASES)
Time (weeks) to return to work and time(weeks) to return to sport

Trial Locations

Locations (1)

Fowler Kennedy Sport Medicine Clinic; 🇨🇦 London, Ontario, Canada