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
About this trial
This is an interventional diagnostic trial for Kyphosis focused on measuring spinal curvatures
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
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
NCT ID
NCT02165514
First Posted
June 11, 2014
Last Updated
June 13, 2014
Sponsor
University of Michigan
Collaborators
GE Healthcare
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
Learn more about this trial
Cobb Angle Measurement of Kyphosis and Scoliosis
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