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Immobilization in External Rotation of Acute Shoulder Dislocations
This study has been completed.
Study NCT00196560   Information provided by Fowler Kennedy Sport Medicine Clinic
First Received: September 12, 2005   Last Updated: January 28, 2009   History of Changes

September 12, 2005
January 28, 2009
September 2003
June 2007   (final data collection date for primary outcome measure)
Recurrent Instability at 24 months
Same as current
Complete list of historical versions of study NCT00196560 on ClinicalTrials.gov Archive Site
  • Time (weeks) to return to work and time(weeks) to return to sport
  • Complications (resulting from immobilization)
  • Compliance with immobilization protocol
  • Western Ontario Shoulder Instability index (WOSI)
  • American Shoulder and Elbow Surgeons questionnaire (ASES)
Same as current
 
Immobilization in External Rotation of Acute Shoulder Dislocations
A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder

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.

 
Phase III
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Anterior Shoulder Dislocation
Device: Immobilization in External Rotation
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
15 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00196560
Elizabeth Wambolt, FKSMC
FKSMC PSI ERAADS
Fowler Kennedy Sport Medicine Clinic
  • The Physicians' Services Incorporated Foundation
  • American Shoulder and Elbow Surgeons
Principal Investigator: Robert B Litchfield, MD, FRCS(C) Fowler Kennedy Sport Medicine Clinic
Fowler Kennedy Sport Medicine Clinic
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP