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Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

This study has been withdrawn prior to enrollment.
(Study has been withdrawn.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585234
First Posted: January 3, 2008
Last Update Posted: December 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
john t. smith, University of Utah
  Purpose

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.


Condition Intervention
Thoracic Insufficiency Syndrome TIS Other: Digital Photography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Further study details as provided by john t. smith, University of Utah:

Primary Outcome Measures:
  • Improvement in overall global balance following surgical intervention [ Time Frame: Dec 2005-Dec 2008 ]

Secondary Outcome Measures:
  • Improvement in overall global balance [ Time Frame: Dec 2005-Dec 2008 ]

Enrollment: 0
Study Start Date: December 2005
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Digital Photography
Digital Photography

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Center
Criteria

Inclusion Criteria:

  • Male and female participants from 1- skeletal maturity

Exclusion Criteria:

  • no specific disease related exclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585234


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: John T Smith, MD University of Utah
  More Information

Responsible Party: john t. smith, Clinical Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00585234     History of Changes
Other Study ID Numbers: 00014137
IRB# 00014137
First Submitted: December 21, 2007
First Posted: January 3, 2008
Last Update Posted: December 10, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Congenital Abnormalities