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

NCT ID: NCT02197819

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2018-02-01

Brief Summary

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.

Conditions

Primary Anterior Shoulder Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

External Rotation Brace

Shoulder placed in an external rotation brace for 4 weeks

Group Type: EXPERIMENTAL

External Rotation Brace

Intervention Type: DEVICE

Traditional Sling

Patient placed in traditional sling

Group Type: ACTIVE_COMPARATOR

Sling

Intervention Type: DEVICE

Interventions

Sling

Intervention Type: DEVICE

External Rotation Brace

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

EERAADS

Identifier Type: -

Identifier Source: org_study_id