Cobb Angle Measurement of Kyphosis and Scoliosis | NCT02165514

Studies
Cobb Angle Measurement of Kyphosis and Scoliosis

NCT02165514

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Jun 17, 2014Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Kyphosis
Scoliosis

Interventions

Lunar iDXA x-ray scan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jun 11, 2014

First Submission Date that Met QC Criteria

Jun 13, 2014

First Posted Date

Jun 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2014

Last Update Posted Date

Jun 17, 2014Estimated

Name	Class
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lunar iDXA (DEXA) scan	Experimental	Spinal scans taken by DEXA scanner	Procedure: Lunar iDXA x-ray scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lunar iDXA x-ray scan	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cobb angle measurements in degrees of spine curvature	Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs	3 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yebin Jiang, PhD	University of Michigan Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007738	Kyphosis
D012600	Scoliosis
D013121	Spinal Curvatures

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided