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Cobb Angle Measurement of Kyphosis and Scoliosis

Primary Purpose

Kyphosis, Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lunar iDXA x-ray scan
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kyphosis focused on measuring spinal curvatures

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age
  • Have Kyphosis or Scoliosis
  • Have had an x-ray of the spine performed within 3 months time

Exclusion Criteria:

  • Are unwilling to read and sign this document
  • Are pregnant or if you have not had a negative pregnancy test just prior to the iDXA scan.
  • Have severe deformities of your back
  • Unable to lay on the scanning table for the scan

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lunar iDXA (DEXA) scan

    Arm Description

    Spinal scans taken by DEXA scanner

    Outcomes

    Primary Outcome Measures

    Cobb angle measurements in degrees of spine curvature
    Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2014
    Last Updated
    June 13, 2014
    Sponsor
    University of Michigan
    Collaborators
    GE Healthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02165514
    Brief Title
    Cobb Angle Measurement of Kyphosis and Scoliosis
    Official Title
    Traditional Cobb Angle Measurement of Kyphosis and Scoliosis Using Lunar IDXA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    GE Healthcare

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan.
    Detailed Description
    To determine if bone density scanning (DEXA) and the use of a computer software program can make accurate measurements of the curvature(s) of the spine (Cobb angle)in patients with kyphosis and scoliosis compared to x-rays of the spine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kyphosis, Scoliosis
    Keywords
    spinal curvatures

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lunar iDXA (DEXA) scan
    Arm Type
    Experimental
    Arm Description
    Spinal scans taken by DEXA scanner
    Intervention Type
    Procedure
    Intervention Name(s)
    Lunar iDXA x-ray scan
    Intervention Description
    Subjects will lay either on their back or side depending whether subject has kyphosis or scoliosis. After the DEXA scan the computer will calculate the Cobb angle. The calculation of Cobb angle from the DEXA scan will be compared to the conventional spine x-ray.
    Primary Outcome Measure Information:
    Title
    Cobb angle measurements in degrees of spine curvature
    Description
    Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs
    Time Frame
    3 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age Have Kyphosis or Scoliosis Have had an x-ray of the spine performed within 3 months time Exclusion Criteria: Are unwilling to read and sign this document Are pregnant or if you have not had a negative pregnancy test just prior to the iDXA scan. Have severe deformities of your back Unable to lay on the scanning table for the scan
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yebin Jiang, PhD
    Organizational Affiliation
    University of Michigan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Cobb Angle Measurement of Kyphosis and Scoliosis

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