Anterior Shoulder Dislocation

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT01585467
Collaborator
(none)
300
2
58
150
2.6

Study Details

Study Description

Brief Summary

To compare and validate the two clinical algorithms

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Clinical Decision rules have safely and successfully allowed clinicians to reduce the total number of radiographs ordered, while detecting patients with important pathology or injuries. The Ottawa Ankle and Knee Rules were developed from a series of studies, and have successfully reduced the number of radiographs ordered by physicians without missing serious ankle fractures (1-4). Likewise, the NEXUS group developed a clinical decision rule for the selection of blunt trauma patients who are appropriate for imaging, based on clinical features (5).

    Drs. Hendey and Emond have separately developed similar algorithms for selective radiography in patients with a suspected shoulder dislocation (6-10). The goal of the current study is to compare and validate the two clinical algorithms.

    Both approaches examine clinical features that are readily accessible to the physician at the time of ED evaluation. In the pre-reduction assessment, both algorithms included the mechanism of injury and whether the patient had experienced a previous shoulder dislocation. Hendey additionally assessed whether the physician was clinically confident of the dislocation (8). Emond additionally included the age of the patient, and the presence or absence of humeral ecchymosis (9). In the post-reduction assessment, both algorithms emphasize the importance of clinical certainty of reduction, as well as the presence of a fracture dislocation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Time Perspective:
    Prospective
    Official Title:
    Selective Radiography in Anterior Shoulder Dislocation: Prospective Validation Rule of Decision Rules Derived in Fresno and Quebec
    Study Start Date :
    Feb 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Prospective validation of clinical decision rules [to be measured at study conclusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • adult patients 18 years and older

    • patient with a suspected acute anterior shoulder dislocation

    Exclusion Criteria:
    • patients under 18 years of age

    • prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco-Fresno Fresno California United States 93701
    2 Universite Laval Pavillon Ferdinand-Vandry Qubec Quebec Canada G1V 0A6

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT01585467
    Other Study ID Numbers:
    • 02102010
    First Posted:
    Apr 25, 2012
    Last Update Posted:
    May 7, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by University of California, San Francisco
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 7, 2015