A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder (EERAADS)
Primary Purpose
Primary Anterior Shoulder Dislocation
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sling
External Rotation Brace
Sponsored by
About this trial
This is an interventional treatment trial for Primary Anterior Shoulder Dislocation
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
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
External Rotation Brace
Traditional Sling
Arm Description
Shoulder placed in an external rotation brace for 4 weeks
Patient placed in traditional sling
Outcomes
Primary Outcome Measures
Re-dislocation of shoulder
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02197819
Brief Title
A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
Acronym
EERAADS
Official Title
A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow patient enrolment
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Anterior Shoulder Dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
External Rotation Brace
Arm Type
Experimental
Arm Description
Shoulder placed in an external rotation brace for 4 weeks
Arm Title
Traditional Sling
Arm Type
Active Comparator
Arm Description
Patient placed in traditional sling
Intervention Type
Device
Intervention Name(s)
Sling
Intervention Type
Device
Intervention Name(s)
External Rotation Brace
Primary Outcome Measure Information:
Title
Re-dislocation of shoulder
Time Frame
within 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C1R6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
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