Anterior Shoulder Dislocation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01585467
First received: April 24, 2012
Last updated: January 14, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 actue anterior shoulder dislocation

Exclusion Criteria:

  • patients under 18 years of age
  • prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 24, 2012
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on April 23, 2014