Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity
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 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.|
- Improvement in overall global balance following surgical intervention [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ]
- Improvement in overall global balance [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585234
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||John T Smith, MD||University of Utah|