Immobilization in External Rotation of Acute Shoulder Dislocations

This study has been completed.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
American Shoulder and Elbow Surgeons
Information provided by:
Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:
NCT00196560
First received: September 12, 2005
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Anterior Shoulder Dislocation
Device: Immobilization in External Rotation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder

Resource links provided by NLM:


Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:
  • Recurrent Instability at 24 months

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 50
Study Start Date: September 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196560

Locations
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Fowler Kennedy Sport Medicine Clinic
The Physicians' Services Incorporated Foundation
American Shoulder and Elbow Surgeons
Investigators
Principal Investigator: Robert B Litchfield, MD, FRCS(C) Fowler Kennedy Sport Medicine Clinic
  More Information

Publications:
Rowe CR, Patel D, Southmard WW. The bankart procedure - a study of late results. J Bone Joint Surg (Am) 59: 122, 1977.
Arciero RA, DeBernadino TM. Acute and chronic dislocations of the shoulder. In Norris TR (ed), Orthopaedic Knowledge update: Shoulder and Elbow. Rosemont Il, American Academy of Orthopaedic Surgeons, 1997, pp 69-71.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth Wambolt, FKSMC
ClinicalTrials.gov Identifier: NCT00196560     History of Changes
Other Study ID Numbers: FKSMC PSI ERAADS
Study First Received: September 12, 2005
Last Updated: January 28, 2009
Health Authority: Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:
Immobilization in External Rotation
Acute primary anterior shoulder dislocation

Additional relevant MeSH terms:
Dislocations
Shoulder Dislocation
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014