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

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ClinicalTrials.gov Identifier: NCT05237167
Recruitment Status : Not yet recruiting
First Posted : February 11, 2022
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Aaron Barksdale, University of Nebraska

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glenohumeral Dislocation Procedure: Shoulder reduction Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized diagnostic comparison study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Time to Diagnosis of Glenohumeral Joint Dislocations in the Emergency Department- Traditional Radiography Versus Point-of-care Ultrasound
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrasound
After randomization, these subjects will undergo diagnostic point-of-care ultrasound
 Procedure: Shoulder reduction
This is standard of care and only measure as a time component outcome in the study
Active Comparator: Radiograph
After randomization, these subjects will undergo diagnostic plain radiograph
 Procedure: Shoulder reduction
This is standard of care and only measure as a time component outcome in the study


Outcome Measures
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Primary Outcome Measures :
  1. Time to diagnosis of glenohumeral joint dislocations [ Time Frame: 0 to 60 minutes ]
    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 :
  1. Time to reduction of dislocation joint [ Time Frame: 1 to 6 hours ]
  2. Emergency Department Length of Stay [ Time Frame: 1 to 12 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Aaron Barksdale, Vice Chair of Research (Associate Professor), University of Nebraska
ClinicalTrials.gov Identifier: NCT05237167    
Other Study ID Numbers: 0790-21-FB
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no currently plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aaron Barksdale, University of Nebraska:
glenohumeral dislocation
POC Ultrasound
Plain radiograph
Additional relevant MeSH terms:
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Joint Dislocations
Shoulder Dislocation
Joint Diseases
 Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries