Anterior Shoulder Dislocation

Shoulder Dislocation Clinical Trial

Official title:

Selective Radiography in Anterior Shoulder Dislocation: Prospective Validation Rule of Decision Rules Derived in Fresno and Quebec

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585467
• Other study ID #: 02102010
• Status: Completed
• Phase: N/A
• First received: April 24, 2012
• Last updated: May 5, 2015
• Start date: February 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

To compare and validate the two clinical algorithms

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dislocations
• Shoulder Dislocation

Locations

Country	Name	City	State
Canada	Universite Laval Pavillon Ferdinand-Vandry	Qubec	Quebec
United States	University of California, San Francisco-Fresno	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (10)

Emond M, Le Sage N, Lavoie A, Moore L. Refinement of the Quebec decision rule for radiography in shoulder dislocation. CJEM. 2009 Jan;11(1):36-43. — View Citation

Emond M, Le Sage N, Lavoie A, Rochette L. Clinical factors predicting fractures associated with an anterior shoulder dislocation. Acad Emerg Med. 2004 Aug;11(8):853-8. — View Citation

Hendey GW, Chally MK, Stewart VB. Selective radiography in 100 patients with suspected shoulder dislocation. J Emerg Med. 2006 Jul;31(1):23-8. — View Citation

Hendey GW, Kinlaw K. Clinically significant abnormalities in postreduction radiographs after anterior shoulder dislocation. Ann Emerg Med. 1996 Oct;28(4):399-402. — View Citation

Hendey GW. Necessity of radiographs in the emergency department management of shoulder dislocations. Ann Emerg Med. 2000 Aug;36(2):108-13. — View Citation

Hoffman JR, Mower WR, Wolfson AB, Todd KH, Zucker MI. Validity of a set of clinical criteria to rule out injury to the cervical spine in patients with blunt trauma. National Emergency X-Radiography Utilization Study Group. N Engl J Med. 2000 Jul 13;343(2):94-9. Erratum in: N Engl J Med 2001 Feb 8;344(6):464. — View Citation

Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Reardon M, Stewart JP, Maloney J. Decision rules for the use of radiography in acute ankle injuries. Refinement and prospective validation. JAMA. 1993 Mar 3;269(9):1127-32. — View Citation

Stiell IG, Greenberg GH, Wells GA, McDowell I, Cwinn AA, Smith NA, Cacciotti TF, Sivilotti ML. Prospective validation of a decision rule for the use of radiography in acute knee injuries. JAMA. 1996 Feb 28;275(8):611-5. — View Citation

Stiell IG, McKnight RD, Greenberg GH, McDowell I, Nair RC, Wells GA, Johns C, Worthington JR. Implementation of the Ottawa ankle rules. JAMA. 1994 Mar 16;271(11):827-32. — View Citation

Stiell IG, Wells GA, Vandemheen KL, Clement CM, Lesiuk H, De Maio VJ, Laupacis A, Schull M, McKnight RD, Verbeek R, Brison R, Cass D, Dreyer J, Eisenhauer MA, Greenberg GH, MacPhail I, Morrison L, Reardon M, Worthington J. The Canadian C-spine rule for radiography in alert and stable trauma patients. JAMA. 2001 Oct 17;286(15):1841-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospective validation of clinical decision rules		to be measured at study conclusion	Yes