Anterior Shoulder Dislocation
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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 |
- 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 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
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 |
Community sample
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| Contact: Gregory Hendey, MD | 5594996440 | ghendey@fresno.ucsf.edu |
| Contact: Marcel Emond, MD |
| United States, California | |
| University of California, San Francisco-Fresno | Recruiting |
| Fresno, California, United States, 93701 | |
| Contact: Gregory Hendey, MD 559-499-6440 ghendey@fresno.ucsf.edu | |
| Contact: Svetlana Bagdasarov, MPH 5594996440 sbagdasarov@fresno.ucsf.edu | |
| Canada, Quebec | |
| Universite Laval Pavillon Ferdinand-Vandry | Recruiting |
| Qubec, Quebec, Canada, G1V 0A6 | |
| Contact: Marcel Emond, MD 4186562131 marcel.emond.1@ulaval.ca | |
More Information
Publications:
| Responsible Party: | Gregory Hendey, Clinical Professor of Medicine, 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: | May 20, 2013 |
| 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 May 22, 2013