Time to Diagnosis of Glenohumeral Joint Dislocations in the ED- Traditional Radiography vs. POC Ultrasound
Primary Purpose
Glenohumeral Dislocation
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shoulder reduction
Sponsored by
About this trial
This is an interventional diagnostic trial for Glenohumeral Dislocation focused on measuring glenohumeral dislocation, POC Ultrasound, Plain radiograph
Eligibility Criteria
Inclusion Criteria:
- Adult patients (19 and older in state of Nebraska) who present to the emergency department with shoulder pain/injury and potential shoulder dislocation
Exclusion Criteria:
- Injury sustained in major traumatic event (trauma activation), unable to consent, in extremis, less then 19 years of age
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound
Radiograph
Arm Description
After randomization, these subjects will undergo diagnostic point-of-care ultrasound
After randomization, these subjects will undergo diagnostic plain radiograph
Outcomes
Primary Outcome Measures
Time to diagnosis of glenohumeral joint dislocations
Comparison between point-of-care ultrasound and plain radiograph in time to diagnosis of glenohumeral joint dislocations who present to the emergency department
Secondary Outcome Measures
Time to reduction of dislocation joint
Time from presentation in Emergency Department to treatment (reduction of joint dislocation)
Emergency Department Length of Stay
Total time in Emergency Department
Full Information
NCT ID
NCT05237167
First Posted
January 17, 2022
Last Updated
August 16, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT05237167
Brief Title
Time to Diagnosis of Glenohumeral Joint Dislocations in the ED- Traditional Radiography vs. POC Ultrasound
Official Title
Time to Diagnosis of Glenohumeral Joint Dislocations in the Emergency Department- Traditional Radiography Versus Point-of-care Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study was ultimately found to be too difficult to enroll patients and have an adequate control.
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is study to compare the time to diagnosis of glenohumeral joint dislocation using two imaging methods, traditional x-ray and point-of-care ultrasound. Participants who present at the emergency department complaining of shoulder injury and who are suspected of having a possible glenohumeral shoulder dislocation will be eligible for the study. A reduction of the joint will be performed if imaging findings so indicate. All participants will receive a post-reduction x-ray and be referred to appropriate follow-up care.
Detailed Description
This is a prospective comparison study evaluating the time to diagnosis of glenohumeral joint dislocation using two imaging modalities, traditional x-ray and point-of-care ultrasound. Eligible participants will include those who present to the emergency department with complaints of shoulder injury who are suspected by triage nursing of having a possible glenohumeral shoulder dislocation. Eligible participants will be consented by participating physicians and randomized into ultrasound or x-ray groups. If indicated based on the imaging findings, a reduction of the joint will be performed. All patients will receive a post-reduction x-ray and be referred to appropriate follow-up care based on the findings of their evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glenohumeral Dislocation
Keywords
glenohumeral dislocation, POC Ultrasound, Plain radiograph
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized diagnostic comparison study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
After randomization, these subjects will undergo diagnostic point-of-care ultrasound
Arm Title
Radiograph
Arm Type
Active Comparator
Arm Description
After randomization, these subjects will undergo diagnostic plain radiograph
Intervention Type
Procedure
Intervention Name(s)
Shoulder reduction
Intervention Description
This is standard of care and only measure as a time component outcome in the study
Primary Outcome Measure Information:
Title
Time to diagnosis of glenohumeral joint dislocations
Description
Comparison between point-of-care ultrasound and plain radiograph in time to diagnosis of glenohumeral joint dislocations who present to the emergency department
Time Frame
0 to 60 minutes
Secondary Outcome Measure Information:
Title
Time to reduction of dislocation joint
Description
Time from presentation in Emergency Department to treatment (reduction of joint dislocation)
Time Frame
1 to 6 hours
Title
Emergency Department Length of Stay
Description
Total time in Emergency Department
Time Frame
1 to 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients (19 and older in state of Nebraska) who present to the emergency department with shoulder pain/injury and potential shoulder dislocation
Exclusion Criteria:
Injury sustained in major traumatic event (trauma activation), unable to consent, in extremis, less then 19 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradford C Huff, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no currently plan to share IPD with other researchers.
Citations:
PubMed Identifier
32111508
Citation
Secko MA, Reardon L, Gottlieb M, Morley EJ, Lohse MR, Thode HC Jr, Singer AJ. Musculoskeletal Ultrasonography to Diagnose Dislocated Shoulders: A Prospective Cohort. Ann Emerg Med. 2020 Aug;76(2):119-128. doi: 10.1016/j.annemergmed.2020.01.008. Epub 2020 Feb 25.
Results Reference
background
PubMed Identifier
26113487
Citation
Kanji A, Atkinson P, Fraser J, Lewis D, Benjamin S. Delays to initial reduction attempt are associated with higher failure rates in anterior shoulder dislocation: a retrospective analysis of factors affecting reduction failure. Emerg Med J. 2016 Feb;33(2):130-3. doi: 10.1136/emermed-2015-204746. Epub 2015 Jun 25.
Results Reference
background
PubMed Identifier
28874947
Citation
Gottlieb M, Russell F. Diagnostic Accuracy of Ultrasound for Identifying Shoulder Dislocations and Reductions: A Systematic Review of the Literature. West J Emerg Med. 2017 Aug;18(5):937-942. doi: 10.5811/westjem.2017.5.34432. Epub 2017 Jul 10.
Results Reference
background
PubMed Identifier
23489654
Citation
Abbasi S, Molaie H, Hafezimoghadam P, Zare MA, Abbasi M, Rezai M, Farsi D. Diagnostic accuracy of ultrasonographic examination in the management of shoulder dislocation in the emergency department. Ann Emerg Med. 2013 Aug;62(2):170-5. doi: 10.1016/j.annemergmed.2013.01.022. Epub 2013 Mar 13.
Results Reference
background
PubMed Identifier
27330675
Citation
Lahham S, Becker B, Chiem A, Joseph LM, Anderson CL, Wilson SP, Subeh M, Trinh A, Viquez E, Fox JC. Pilot Study to Determine Accuracy of Posterior Approach Ultrasound for Shoulder Dislocation by Novice Sonographers. West J Emerg Med. 2016 May;17(3):377-82. doi: 10.5811/westjem.2016.2.29290. Epub 2016 Apr 26.
Results Reference
background
PubMed Identifier
26935225
Citation
Akyol C, Gungor F, Akyol AJ, Kesapli M, Guven R, Cengiz U, Toksul HI, Eken C. Point-of-care ultrasonography for the management of shoulder dislocation in ED. Am J Emerg Med. 2016 May;34(5):866-70. doi: 10.1016/j.ajem.2016.02.006. Epub 2016 Feb 16.
Results Reference
background
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Time to Diagnosis of Glenohumeral Joint Dislocations in the ED- Traditional Radiography vs. POC Ultrasound
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