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Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

This study is ongoing, but not recruiting participants.
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
History of Changes
  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 University of Utah:

Primary Outcome Measures:
  • Improvement in overall global balance following surgical intervention [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in overall global balance [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2005
Estimated Study Completion Date: March 2012
Estimated 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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: john t. smith, Clinical Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00585234     History of Changes
Other Study ID Numbers: 00014137, IRB# 00014137
Study First Received: December 21, 2007
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013