A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder (EERAADS)

Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2% in the general population. In young patients, recurrence after a primary dislocation is also common (~60%) and multiple recurrent episodes can cause significant disability over time. Following initial reduction of the joint, the traditional treatment for primary shoulder dislocations has been immobilization in a sling, with the arm in a position of adduction and internal rotation. The length of the immobilization period is controversial, however most authors would recommend between three to six weeks in a sling followed by several months of rehabilitation to include range of motion and strengthening exercises. The clinical course of patients after this approach has been extensively investigated. Of particular interest is the relatively high rate of recurrent instability in young patients, reported to be between 17 and 96%.

A prospective randomized trial is needed to determine whether in young patients (16-30 yrs of age) following reduction of a first-time traumatic anterior shoulder dislocation, does EMERGENT (<4 hours post reduction) immobilization of the affected shoulder in external rotation reduce the rate of recurrent instability experienced within 12 months versus emergent immobilization in a traditional internal rotation sling? Eligible patients will be randomly allocated to the sling or ER brace. The results of this study will provide the best evidence for choosing emergent immobilization for shoulder dislocations.

Study Overview

• Status: Terminated
• Conditions: Primary Anterior Shoulder Dislocation
• Intervention / Treatment: Device: External Rotation Brace; Device: Sling

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C1R6
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Skeletally mature patients between 18 - 35 years of age inclusive
• Patient is seen within 24 hours from time of injury.
• Sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by;
• Mechanism of abduction, external rotation
• Sudden pain in the shoulder
• Manipulative reduction required or
• Radiograph documenting a dislocated joint
• Willing to participate in follow-up for at least 24 months.

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.
• Neurovascular compromise of the affected limb
• A medical condition making the patient unable to wear a brace or sling
• Patient is seen within 24 hours from time of injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: External Rotation Brace; Shoulder placed in an external rotation brace for 4 weeks	Device: External Rotation Brace
Active Comparator: Traditional Sling; Patient placed in traditional sling	Device: Sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Re-dislocation of shoulder	within 12 months

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: EERAADS