Clinical trial NCT00196560: Immobilization in External Rotation of Acute Shoulder Dislocations
Official title: A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Shoulder Dislocation
Keywords: Immobilization in External Rotation
Acute primary anterior shoulder dislocation
Lead sponsor: Fowler Kennedy Sport Medicine Clinic
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
name: American Shoulder and Elbow Surgeons
First posted: 2005-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24 months.

Detailed description: Immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation)should reduce the rate of recurrent dislocations experienced in 24 months.

Eligibility criteria: Inclusion Criteria:

* skeletally mature patients less than 30 years of age
* sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. Mechanism of abduction, external rotation ii. Sudden pain in the shoulder iii. Manipulative reduction required or iv. Radiograph documenting a dislocated joint
* willing to participate in follow-up for at least two years

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
* a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder
* neurovascular compromise of the affected limb
* a medical condition making the patient unable to wear a brace or sling

Primary outcomes:
measure: Recurrent Instability at 24 months
Secondary outcomes:
measure: Time (weeks) to return to work and time(weeks) to return to sport
measure: Complications (resulting from immobilization)
measure: Compliance with immobilization protocol
measure: Western Ontario Shoulder Instability index (WOSI)
measure: American Shoulder and Elbow Surgeons questionnaire (ASES)
Other outcomes:
Locations:
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic
state: Ontario
Study officials:
affiliation: Fowler Kennedy Sport Medicine Clinic
name: Robert B Litchfield, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
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