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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Withdrawn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
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glenohumeral Dislocation focused on measuring glenohumeral dislocation, POC Ultrasound, Plain radiograph

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 17, 2022
    Last Updated
    August 16, 2023
    Sponsor
    University of Nebraska
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    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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