ClinicalTrials.gg
WithdrawnNCT05237167Updated Sep 3, 2024

Time to Diagnosis of Glenohumeral Joint Dislocations in the ED- Traditional Radiography vs. POC Ultrasound

An interventional study of Shoulder reduction in Glenohumeral Dislocation, sponsored by University of Nebraska. Withdrawn. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by University of Nebraska · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
The study was ultimately found to be too difficult to enroll patients and have an adequate control.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Glenohumeral Dislocation

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Keywords

  • glenohumeral dislocation
  • POC Ultrasound
  • Plain radiograph
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In context

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

Browse Shoulder Dislocation studies →

Lead sponsor

University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Injury sustained in major traumatic event (trauma activation), unable to consent, in extremis, less then 19 years of age
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Ultrasound

    After randomization, these subjects will undergo diagnostic point-of-care ultrasound

    Procedure: Shoulder reduction

  • Active comparator
    Radiograph

    After randomization, these subjects will undergo diagnostic plain radiograph

    Procedure: Shoulder reduction

Interventions

  • ProcedureShoulder reduction

    This is standard of care and only measure as a time component outcome in the study

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 0 to 60 minutes

Secondary outcomes

  1. Time to reduction of dislocation joint

    Time from presentation in Emergency Department to treatment (reduction of joint dislocation)

    Time frame: 1 to 6 hours

  2. Emergency Department Length of Stay

    Total time in Emergency Department

    Time frame: 1 to 12 hours

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32111508 ↗
  • 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. PubMed 26113487 ↗
  • 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. PubMed 28874947 ↗
  • 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. PubMed 23489654 ↗
  • 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. PubMed 27330675 ↗
  • 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. PubMed 26935225 ↗

Individual participant data

Plan to share: No — There is no currently plan to share IPD with other researchers.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05237167
Responsible party
Sponsor
First posted
Feb 11, 2022
Start date
Jul 5, 2022
Primary completion
Jul 5, 2022
Completion
Jul 5, 2022
Last update
Sep 3, 2024

Study contacts

Bradford C Huff, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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