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

Conditions

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.

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

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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