NCT02165514

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

2.4 years

First QC Date

June 11, 2014

Last Update Submit

June 13, 2014

Conditions

KyphosisScoliosis

Keywords

spinal curvatures

Outcome Measures

Primary Outcomes (1)

  • Cobb angle measurements in degrees of spine curvature

    Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs

    3 year

Study Arms (1)

Lunar iDXA (DEXA) scan

EXPERIMENTAL

Spinal scans taken by DEXA scanner

Procedure: Lunar iDXA x-ray scan

Interventions

Lunar iDXA x-ray scanPROCEDURE

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.

Lunar iDXA (DEXA) scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Have Kyphosis or Scoliosis
  • Have had an x-ray of the spine performed within 3 months time

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

KyphosisScoliosisSpinal Curvatures

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Yebin Jiang, PhD

    University of Michigan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 17, 2014

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 17, 2014

Record last verified: 2014-06