Back to resultsEvaluation of Bone Length Measurement
Primary Purpose
Bone Calcification, Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lunar iXDA scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Bone Calcification
Eligibility Criteria
Inclusion Criteria:
- Age 18 yrs. of age or older
- Have recent x-rays of lower extremity
- Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches.
Exclusion Criteria:
- Are unwilling to read and sign the consent
- Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan
- Have severe deformities of your legs or back
- Unable to lay on the scanning table for the scan
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
x-ray with iXDA scan
Arm Description
Tota body scan taken by the Lunar iXDA. During the scan, subject will be asked to lay on their back. Following the Lunar iDXA scan, the computer of the Luna iXDA will calculate bone length. The calculation of bone length will be compared to a calculation from the subject's conventional x-ray to determine accuracy.
Outcomes
Primary Outcome Measures
Leg (Femur and Tibia) bone length measurement in centimeters using iDXA
Lunar iXDA computer will calculate the bone length following a total body scan taken by the Lunar iDXA and compare results from conventional x-ray to determine accuracy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02165527
Brief Title
Evaluation of Bone Length Measurement
Official Title
Evaluation of Bone Length Measurement Using Lunar iDXA
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays.
Detailed Description
The investigators would like to see how well the calculation of bone length using Lunar iDxa compares to conventional x-ray since the Lunar iXDA exposed patients to less radiation than conventional x-rays.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Calcification, Osteoporosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
x-ray with iXDA scan
Arm Type
Experimental
Arm Description
Tota body scan taken by the Lunar iXDA. During the scan, subject will be asked to lay on their back. Following the Lunar iDXA scan, the computer of the Luna iXDA will calculate bone length. The calculation of bone length will be compared to a calculation from the subject's conventional x-ray to determine accuracy.
Intervention Type
Procedure
Intervention Name(s)
Lunar iXDA scan
Intervention Description
Subject will receive a total body scan taken by the Lunar iXDA. This scan will take approximately 8 minutes to complete. Following the scan, the computer of the Lunar iXDA will calculate the bone length.
Primary Outcome Measure Information:
Title
Leg (Femur and Tibia) bone length measurement in centimeters using iDXA
Description
Lunar iXDA computer will calculate the bone length following a total body scan taken by the Lunar iDXA and compare results from conventional x-ray to determine accuracy.
Time Frame
scan time is 8 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 yrs. of age or older
Have recent x-rays of lower extremity
Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches.
Exclusion Criteria:
Are unwilling to read and sign the consent
Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan
Have severe deformities of your legs or back
Unable to lay on the scanning table for the scan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yebin Jiang, MD, PhD
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
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Evaluation of Bone Length Measurement
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