- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02165514
Cobb Angle Measurement of Kyphosis and Scoliosis
June 13, 2014 updated by: Yebin Jiang, M.D., University of Michigan
Traditional Cobb Angle Measurement of Kyphosis and Scoliosis Using Lunar IDXA
Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lunar iDXA (DEXA) scan
Spinal scans taken by DEXA scanner
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cobb angle measurements in degrees of spine curvature
Time Frame: 3 year
|
Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yebin Jiang, PhD, University of Michigan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00029355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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