Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

NCT ID: NCT00585234

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Thoracic Insufficiency Syndrome TIS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Digital Photography

Intervention Type OTHER

Digital Photography

Interventions

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Digital Photography

Digital Photography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and female participants from 1- skeletal maturity
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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john t. smith

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John T Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB# 00014137

Identifier Type: -

Identifier Source: secondary_id

00014137

Identifier Type: -

Identifier Source: org_study_id

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