NCT02197819: EERAADS

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

Terminated NA Last updated 4 April 2019

What this trial tests

NA trial testing Sling in Primary Anterior Shoulder Dislocation in 3 participants. Terminated before completion.

Timeline

1 February 2013

Primary endpoint
1 February 2018

1 February 2018

Quick facts

Lead sponsor	Unity Health Toronto
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 February 2013
Primary completion	1 February 2018
Estimated completion	1 February 2018
Sites	1 location across Canada

Drugs / interventions tested

• Sling
• External Rotation Brace

Conditions studied

• Primary Anterior Shoulder Dislocation — all drugs for Primary Anterior Shoulder Dislocation →

Sponsor

Unity Health Toronto — full company profile →

Who can join

Adults 18 to 40, any sex, with Primary Anterior Shoulder Dislocation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.
   Braun C, McRobert CJ. · · 2019 · cited 18× · PMID 31074847 · DOI 10.1002/14651858.cd004962.pub4