<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02197819</url>
  </required_header>
  <id_info>
    <org_study_id>EERAADS</org_study_id>
    <nct_id>NCT02197819</nct_id>
  </id_info>
  <brief_title>A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder</brief_title>
  <acronym>EERAADS</acronym>
  <official_title>A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2%&#xD;
      in the general population. In young patients, recurrence after a primary dislocation is also&#xD;
      common (~60%) and multiple recurrent episodes can cause significant disability over time.&#xD;
      Following initial reduction of the joint, the traditional treatment for primary shoulder&#xD;
      dislocations has been immobilization in a sling, with the arm in a position of adduction and&#xD;
      internal rotation. The length of the immobilization period is controversial, however most&#xD;
      authors would recommend between three to six weeks in a sling followed by several months of&#xD;
      rehabilitation to include range of motion and strengthening exercises. The clinical course of&#xD;
      patients after this approach has been extensively investigated. Of particular interest is the&#xD;
      relatively high rate of recurrent instability in young patients, reported to be between 17&#xD;
      and 96%.&#xD;
&#xD;
      A prospective randomized trial is needed to determine whether in young patients (16-30 yrs of&#xD;
      age) following reduction of a first-time traumatic anterior shoulder dislocation, does&#xD;
      EMERGENT (&lt;4 hours post reduction) immobilization of the affected shoulder in external&#xD;
      rotation reduce the rate of recurrent instability experienced within 12 months versus&#xD;
      emergent immobilization in a traditional internal rotation sling? Eligible patients will be&#xD;
      randomly allocated to the sling or ER brace. The results of this study will provide the best&#xD;
      evidence for choosing emergent immobilization for shoulder dislocations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow patient enrolment&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2013</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Re-dislocation of shoulder</measure>
    <time_frame>within 12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Primary Anterior Shoulder Dislocation</condition>
  <arm_group>
    <arm_group_label>External Rotation Brace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shoulder placed in an external rotation brace for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Sling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient placed in traditional sling</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sling</intervention_name>
    <arm_group_label>Traditional Sling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>External Rotation Brace</intervention_name>
    <arm_group_label>External Rotation Brace</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Skeletally mature patients between 18 - 35 years of age inclusive&#xD;
&#xD;
          -  Patient is seen within 24 hours from time of injury.&#xD;
&#xD;
          -  Sustained an acute, first-time, traumatic anterior dislocation of the shoulder as&#xD;
             defined by;&#xD;
&#xD;
          -  Mechanism of abduction, external rotation&#xD;
&#xD;
          -  Sudden pain in the shoulder&#xD;
&#xD;
          -  Manipulative reduction required or&#xD;
&#xD;
          -  Radiograph documenting a dislocated joint&#xD;
&#xD;
          -  Willing to participate in follow-up for at least 24 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incompetent or unwilling to consent&#xD;
&#xD;
          -  Inability or unwillingness to comply with rehabilitative protocol or required&#xD;
             follow-up assessments.&#xD;
&#xD;
          -  Previous instability of the affected shoulder&#xD;
&#xD;
          -  Significant associated fracture (Exception Hill Sachs or bankart lesions)&#xD;
&#xD;
          -  Concomitant ipsilateral upper extremity injuries which may affect the patient's&#xD;
             ability to participate in, or benefit from, a rehabilitative program.&#xD;
&#xD;
          -  Neurovascular compromise of the affected limb&#xD;
&#xD;
          -  A medical condition making the patient unable to wear a brace or sling&#xD;
&#xD;
          -  Patient is seen within 24 hours from time of injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C1R6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Shoulder Dislocation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02197819
org study id: EERAADS
nct id: NCT02197819
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Re-dislocation of shoulder
time frame: within 12 months
arm group label: External Rotation Brace
arm group type: Experimental
description: Shoulder placed in an external rotation brace for 4 weeks
arm group label: Traditional Sling
arm group type: Active Comparator
description: Patient placed in traditional sling
intervention type: Device
intervention name: Sling
arm group label: Traditional Sling
intervention type: Device
intervention name: External Rotation Brace
arm group label: External Rotation Brace
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Shoulder Dislocation