A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acut… (NCT02197819) | Clinical Trial Compass
TerminatedNot Applicable
A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
Stopped: Slow patient enrolment
Canada3 participantsStarted 2013-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.