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Musculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction

Primary Purpose

Ultrasound, Shoulder Dislocation, Musculoskeletal Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Point of care ultrasound
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults greater than or equal to 18 years
  • Acute shoulder dislocation

Exclusion Criteria:

  • Associated fracture
  • Associated neurovascular injury

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Self Controlled

    Arm Description

    Patients will active as their own comparator

    Outcomes

    Primary Outcome Measures

    Comparison of X ray to Ultrasound for Shoulder Reduction
    Compare the impression of the x ray to the ultrasound for successful shoulder reduction

    Secondary Outcome Measures

    Comparison of X ray to Ultrasound in the diagnosis of post shoulder reduction complications
    Compare the impression of the x ray to the ultrasound for shoulder dislocation complications

    Full Information

    First Posted
    December 16, 2020
    Last Updated
    January 8, 2021
    Sponsor
    Rutgers, The State University of New Jersey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04703517
    Brief Title
    Musculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction
    Official Title
    Musculoskeletal Ultrasonography to Diagnose Successful Reduction of Shoulder Dislocation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    December 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rutgers, The State University of New Jersey

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This study will compare the current standard of care post reduction plain film x ray for confirmation of shoulder reduction to point of care ultrasound. Patients will receive both the current standard of care post reduction x ray and point of care ultrasound to act as their own comparators

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ultrasound, Shoulder Dislocation, Musculoskeletal Injury

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Self Controlled
    Arm Type
    Other
    Arm Description
    Patients will active as their own comparator
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Point of care ultrasound
    Intervention Description
    Patients will receive a point of care ultrasound at the bedside in the Emergency Department and compare the impression to the x ray result
    Primary Outcome Measure Information:
    Title
    Comparison of X ray to Ultrasound for Shoulder Reduction
    Description
    Compare the impression of the x ray to the ultrasound for successful shoulder reduction
    Time Frame
    through study completion up to 1 year
    Secondary Outcome Measure Information:
    Title
    Comparison of X ray to Ultrasound in the diagnosis of post shoulder reduction complications
    Description
    Compare the impression of the x ray to the ultrasound for shoulder dislocation complications
    Time Frame
    through study completion up to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults greater than or equal to 18 years Acute shoulder dislocation Exclusion Criteria: Associated fracture Associated neurovascular injury
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jesper Aurup, MD
    Phone
    732-258-9267
    Email
    ja1137@rwjms.rutgers.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Musculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction

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