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

NCT02197819 | Terminated

• 1 other identifier: EERAADS
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Re-dislocation of shoulder

  within 12 months

Study Arms (2)

External Rotation Brace

EXPERIMENTAL

Shoulder placed in an external rotation brace for 4 weeks

Device: External Rotation Brace

Traditional Sling

ACTIVE COMPARATOR

Patient placed in traditional sling

Device: Sling

Interventions

Sling DEVICE

Traditional Sling

External Rotation Brace DEVICE

External Rotation Brace

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C1R6, Canada

Location

MeSH Terms

Interventions

Suburethral Slings

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: February 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 4, 2019

Record last verified: 2018-04

Locations

CA (1)