Immobilization in External Rotation of Acute Shoulder Dislocations

November 26, 2015 updated by: Sharon Griffin, Fowler Kennedy Sport Medicine Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sport Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exernal rotation
external rotation at 90 degrees
Device: Immobilization in External Rotation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Recurrent Instability at 24 months

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fowler Kennedy Sport Medicine Clinic

Collaborators

The Physicians' Services Incorporated Foundation
American Shoulder and Elbow Surgeons

Investigators

  • Principal Investigator: Robert B Litchfield, MD, FRCS(C), Fowler Kennedy Sport Medicine Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 26, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKSMC PSI ERAADS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe