Cobb Angle Measurement of Kyphosis and Scoliosis

NCT ID: NCT02165514

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan.

Detailed Description

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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.

Conditions

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Kyphosis Scoliosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lunar iDXA (DEXA) scan

Spinal scans taken by DEXA scanner

Group Type EXPERIMENTAL

Lunar iDXA x-ray scan

Intervention Type PROCEDURE

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.

Interventions

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Lunar iDXA x-ray scan

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Yebin Jiang, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yebin Jiang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Other Identifiers

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HUM00029355

Identifier Type: -

Identifier Source: org_study_id

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