NCT00196560CompletedPhase 3
A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
Fowler Kennedy Sport Medicine Clinic1 site in 1 country50 target enrollmentStarted: September 1, 2003Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Recurrent Instability at 24 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
exernal rotation
Experimental
external rotation at 90 degrees
Intervention: Immobilization in External Rotation (Device)
Outcomes
Primary Outcomes
Recurrent Instability at 24 months
Secondary Outcomes
- Western Ontario Shoulder Instability index (WOSI)
- Time (weeks) to return to work and time(weeks) to return to sport
- Complications (resulting from immobilization)
- Compliance with immobilization protocol
- American Shoulder and Elbow Surgeons questionnaire (ASES)
Investigators
Sharon Griffin
Research Coordinator
Fowler Kennedy Sport Medicine Clinic
Study Sites (1)
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