Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

Brief Title

Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity

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.

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.
    



Study Type

Observational


Primary Outcome

Improvement in overall global balance following surgical intervention

Secondary Outcome

 Improvement in overall global balance

Condition

Thoracic Insufficiency Syndrome

Intervention

Digital Photography

Study Arms / Comparison Groups

 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

0

Start Date

December 2005

Completion Date

March 2012

Primary Completion Date

March 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female participants from 1- skeletal maturity

        Exclusion Criteria:

          -  no specific disease related exclusion criteria
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

John T Smith, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00585234

Organization ID

00014137

Secondary IDs

IRB# 00014137

Responsible Party

Principal Investigator

Study Sponsor

University of Utah


Study Sponsor

John T Smith, MD, Principal Investigator, University of Utah


Verification Date

December 2014