Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity
This study is ongoing, but not recruiting participants.
Sponsor:
University of Utah
Information provided by (Responsible Party):
john t. smith, University of Utah
ClinicalTrials.gov Identifier:
NCT00585234
First received: December 21, 2007
Last updated: September 19, 2011
Last verified: September 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | September 19, 2011 | ||||
| Start Date ICMJE | December 2005 | ||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improvement in overall global balance following surgical intervention [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00585234 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Improvement in overall global balance [ Time Frame: Dec 2005-Dec 2008 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary Care Center |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Digital Photography
Digital Photography |
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| Study Group/Cohort (s) | 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.
Intervention: Other: Digital Photography |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | March 2012 | ||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00585234 | ||||
| Other Study ID Numbers ICMJE | 00014137, IRB# 00014137 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | john t. smith, University of Utah | ||||
| Study Sponsor ICMJE | University of Utah | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Utah | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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