Evaluation of Bone Length Measurement

Evaluation of Bone Length Measurement Using Lunar iDXA

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Bone Calcification
• Intervention / Treatment: Procedure: Lunar iXDA scan

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: x-ray with iXDA scan; 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.	Procedure: Lunar iXDA scan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	scan time is 8 minutes

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Yebin Jiang, MD, PhD, University of Michigan Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: HUM29462