Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

Withdrawn

• Conditions: Thoracic Insufficiency Syndrome; TIS
• Interventions: Other: Digital Photography

• Registration Number: NCT00585234
• Lead Sponsor: University of Utah

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male and female participants from 1- skeletal maturity

Exclusion Criteria

• no specific disease related exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Digital Photography	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.

Primary Outcome Measures

Name	Time	Method
Improvement in overall global balance following surgical intervention	Dec 2005-Dec 2008

Secondary Outcome Measures

Name	Time	Method
Improvement in overall global balance	Dec 2005-Dec 2008

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States