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Anterior Shoulder Dislocation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585467
First Posted: April 25, 2012
Last Update Posted: May 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
To compare and validate the two clinical algorithms

Condition
Shoulder Dislocation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Selective Radiography in Anterior Shoulder Dislocation: Prospective Validation Rule of Decision Rules Derived in Fresno and Quebec

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Prospective validation of clinical decision rules [ Time Frame: to be measured at study conclusion ]

Enrollment: 300
Study Start Date: February 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community sample
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585467


Locations
United States, California
University of California, San Francisco-Fresno
Fresno, California, United States, 93701
Canada, Quebec
Universite Laval Pavillon Ferdinand-Vandry
Qubec, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01585467     History of Changes
Other Study ID Numbers: 02102010
First Submitted: April 24, 2012
First Posted: April 25, 2012
Last Update Posted: May 7, 2015
Last Verified: May 2015

Keywords provided by University of California, San Francisco:
Anterior Shoulder Dislocation
Shoulder Dislocation
Shoulder Pain
Shoulder Deformity

Additional relevant MeSH terms:
Joint Dislocations
Shoulder Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries