Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

Thoracic Insufficiency Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00585234
• Other study ID #: 00014137
• Secondary ID: IRB# 00014137
• Status: Withdrawn
• Start date: December 2005
• Est. completion date: March 2012

Study information

• Verified date: January 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Male and female participants from 1- skeletal maturity

Exclusion Criteria:

• no specific disease related exclusion criteria

Related Conditions & MeSH terms

• Congenital Abnormalities
• Thoracic Insufficiency Syndrome
• TIS

Intervention

Other:
• Digital Photography
Digital Photography

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in overall global balance following surgical intervention		Dec 2005-Dec 2008
Secondary	Improvement in overall global balance		Dec 2005-Dec 2008