NCT01585467

Brief Summary

To compare and validate the two clinical algorithms

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

4.8 years

First QC Date

April 24, 2012

Last Update Submit

May 5, 2015

Conditions

Shoulder Dislocation

Keywords

Anterior Shoulder DislocationShoulder DislocationShoulder PainShoulder Deformity

Outcome Measures

Primary Outcomes (1)

  • Prospective validation of clinical decision rules

    to be measured at study conclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • adult patients 18 years and older
  • patient with a suspected acute anterior shoulder dislocation

You may not qualify if:

  • patients under 18 years of age
  • prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

Universite Laval Pavillon Ferdinand-Vandry

Qubec, Quebec, G1V 0A6, Canada

Location

Related Publications (10)

  • 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.

    PMID: 8114236BACKGROUND

  • 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. doi: 10.1001/jama.269.9.1127.

    PMID: 8433468BACKGROUND

  • 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. doi: 10.1001/jama.286.15.1841.

    PMID: 11597285BACKGROUND

  • 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.

    PMID: 8594242BACKGROUND

  • 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. doi: 10.1056/NEJM200007133430203.

    PMID: 10891516BACKGROUND

  • Hendey GW, Kinlaw K. Clinically significant abnormalities in postreduction radiographs after anterior shoulder dislocation. Ann Emerg Med. 1996 Oct;28(4):399-402. doi: 10.1016/s0196-0644(96)70004-5.

    PMID: 8839524BACKGROUND

  • Hendey GW. Necessity of radiographs in the emergency department management of shoulder dislocations. Ann Emerg Med. 2000 Aug;36(2):108-113. doi: 10.1067/mem.2000.108314.

    PMID: 10918101BACKGROUND

  • Hendey GW, Chally MK, Stewart VB. Selective radiography in 100 patients with suspected shoulder dislocation. J Emerg Med. 2006 Jul;31(1):23-8. doi: 10.1016/j.jemermed.2005.09.006.

    PMID: 16798149BACKGROUND

  • 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. doi: 10.1017/s1481803500010903.

    PMID: 19166638BACKGROUND

  • 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. doi: 10.1111/j.1553-2712.2004.tb00768.x.

    PMID: 15289192BACKGROUND

MeSH Terms

Conditions

Shoulder DislocationShoulder Pain

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 25, 2012

Study Start

February 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

CA(1)US(1)