Immobilization in External Rotation of Acute Shoulder Dislocations

Sponsor
Fowler Kennedy Sport Medicine Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00196560
Collaborator
The Physicians' Services Incorporated Foundation (Other), American Shoulder and Elbow Surgeons (Other)
50
1
1
45
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Immobilization in External Rotation
Phase 3

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
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: exernal rotation

external rotation at 90 degrees

Device: Immobilization in External Rotation

Outcome Measures

Primary Outcome Measures

  1. Recurrent Instability at 24 months []

Secondary Outcome Measures

  1. Time (weeks) to return to work and time(weeks) to return to sport []

  2. Complications (resulting from immobilization) []

  3. Compliance with immobilization protocol []

  4. Western Ontario Shoulder Instability index (WOSI) []

  5. American Shoulder and Elbow Surgeons questionnaire (ASES) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 30 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sharon Griffin, Research Coordinator, Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:
NCT00196560
Other Study ID Numbers:
  • FKSMC PSI ERAADS
First Posted:
Sep 20, 2005
Last Update Posted:
Nov 30, 2015
Last Verified:
Nov 1, 2015
Keywords provided by Sharon Griffin, Research Coordinator, Fowler Kennedy Sport Medicine Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2015