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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

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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

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




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 ]


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
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