Primary Anterior Shoulder Dislocation Clinical Trial
— EERAADSOfficial title:
A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
| Verified date | April 2018 |
| Source | St. Michael's Hospital, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | February 1, 2018 |
| Est. primary completion date | February 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| St. Michael's Hospital, Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Re-dislocation of shoulder | within 12 months |