Cobb Angle Measurement of Kyphosis and Scoliosis

Scoliosis Clinical Trial

Official title:

Traditional Cobb Angle Measurement of Kyphosis and Scoliosis Using Lunar IDXA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165514
• Other study ID #: HUM00029355
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 13, 2014
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kyphosis
• Scoliosis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cobb angle measurements in degrees of spine curvature	Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs	3 year	No