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Mini-C-Arm for Distal Radius Fractures in Adults

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mini-c-arm
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

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

Inclusion Criteria:

  • Closed distal radius fracture requiring reduction

Exclusion Criteria:

  • Open, other ipsilateral upper extremity fractures, pregnant, incarcerated, less than 18 yo

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mini-c-arm

    Standard

    Arm Description

    Fluoroscopically aided reductions

    Outcomes

    Primary Outcome Measures

    Reduction quality
    Fracture alignment measured on post-reduction radiographs

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2018
    Last Updated
    January 11, 2018
    Sponsor
    University of Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03396965
    Brief Title
    Mini-C-Arm for Distal Radius Fractures in Adults
    Official Title
    The Efficacy of Mini-c-arm Fluoroscopy for the Closed Reduction of Distal Radius Fractures in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cincinnati

    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
    Determine efficacy of the use of mini-c-arm fluoroscopy for the closed reduction of isolated distal radius fractures in adult patients in the emergency department setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Radius Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients randomized to fluoroscopically-aided reduction of fracture, versus no fluoroscopic guidance
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mini-c-arm
    Arm Type
    Experimental
    Arm Description
    Fluoroscopically aided reductions
    Arm Title
    Standard
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Mini-c-arm
    Intervention Description
    Fluoroscopy used to aid reduction of distal radius fracture
    Primary Outcome Measure Information:
    Title
    Reduction quality
    Description
    Fracture alignment measured on post-reduction radiographs
    Time Frame
    Immediately post reduction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Closed distal radius fracture requiring reduction Exclusion Criteria: Open, other ipsilateral upper extremity fractures, pregnant, incarcerated, less than 18 yo

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Mini-C-Arm for Distal Radius Fractures in Adults

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