Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Utah.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
john t. smith, University of Utah
ClinicalTrials.gov Identifier:
NCT00585234
First received: December 21, 2007
Last updated: September 19, 2011
Last verified: September 2011

December 21, 2007
September 19, 2011
December 2005
March 2012   (final data collection date for primary outcome measure)
Improvement in overall global balance following surgical intervention [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585234 on ClinicalTrials.gov Archive Site
Improvement in overall global balance [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity
Tools for Objective Clinical Assessment of Pediatric Spinal Deformity and the Results of Surgical Intervention--Simultaneous Measurement of Sagittal and Coronal Balance and Symmetry With Digital Photography.

This project seeks to develop a standardized technique for simultaneous capturing bi-planar images of patients against a standard background with a grid that can be used later for the quantitative determination of global balance and thoracic symmetry.

We hypothesize that patients who are successfully managed with surgery will demonstrate an improvement in global balance and thoracic symmetry that can be accurately measured. This measurement station will be specifically developed to provide a standardized, reproducible means to compare clinical assessments of surgical and non-surgical outcomes, and establish normative data for comparison. This standardized tool can be established at multiple centers for use in multicenter trials.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary Care Center

  • Thoracic Insufficiency Syndrome
  • TIS
Other: Digital Photography
Digital Photography
1
We intend to photograph male and female subjects from age 1 through skeletal maturity. Healthy children will be photographed to determine the normative characteristics of thoracic function using this technique. We will also enroll patients with thoracic pathology to determine how digital imaging can document thoracic dysfunction. There are no specific disease related exclusion criteria. Participation is voluntary.
Intervention: Other: Digital Photography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female participants from 1- skeletal maturity

Exclusion Criteria:

  • no specific disease related exclusion criteria
Both
up to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585234
00014137, IRB# 00014137
No
john t. smith, University of Utah
University of Utah
Not Provided
Principal Investigator: John T Smith, MD University of Utah
University of Utah
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP