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Ultrasound Examination and Guided Injection Into the Acromio-clavicular Joint

Primary Purpose

Osteoarthritis of Acromioclavicular Joint

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
contrast material injection
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis of Acromioclavicular Joint

Eligibility Criteria

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

Inclusion Criteria:

  • adults over 18 years with AC joint degenerative changes

Sites / Locations

    Outcomes

    Primary Outcome Measures

    ultrasound controlled injection of contrast material into the AC joint followed by standard x-ray
    standard x-ray will be taken after the contrast dye has been injected into the joint to see whether it has successfully been placed into the joint.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 19, 2012
    Last Updated
    June 26, 2012
    Sponsor
    The Baruch Padeh Medical Center, Poriya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01628796
    Brief Title
    Ultrasound Examination and Guided Injection Into the Acromio-clavicular Joint
    Official Title
    Ultrasound Measurement of the Acromio-clavicular Joint and Injection of Standard Contrast Material Into the Joint Under Ultrasonic Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    January 2013 (Anticipated)
    Study Completion Date
    January 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Is it possible to improve the accuracy of injection into the acromio-clavicular joint with the use of ultrasound?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of Acromioclavicular Joint

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    contrast material injection
    Other Intervention Name(s)
    iomeron 350
    Intervention Description
    using ultrasound to locate ac joint and injecting contrast material to ensure that the dye is actually in the joint
    Primary Outcome Measure Information:
    Title
    ultrasound controlled injection of contrast material into the AC joint followed by standard x-ray
    Description
    standard x-ray will be taken after the contrast dye has been injected into the joint to see whether it has successfully been placed into the joint.
    Time Frame
    outcome assessed at the time of the injection (1 day)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: adults over 18 years with AC joint degenerative changes
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gordon Edelson, MD
    Phone
    97246652670
    Email
    edelson@bezeqint.net

    12. IPD Sharing Statement

    Learn more about this trial

    Ultrasound Examination and Guided Injection Into the Acromio-clavicular Joint

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