NCT00585234

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

6.3 years

First QC Date

December 21, 2007

Last Update Submit

January 8, 2024

Conditions

Thoracic Insufficiency SyndromeTIS

Outcome Measures

Primary Outcomes (1)

  • Improvement in overall global balance following surgical intervention

    Dec 2005-Dec 2008

Secondary Outcomes (1)

  • Improvement in overall global balance

    Dec 2005-Dec 2008

Study Arms (1)

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.

Other: Digital Photography

Interventions

Digital PhotographyOTHER

Digital Photography

1

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Center

You may qualify if:

  • Male and female participants from 1- skeletal maturity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Officials

  • John T Smith, MD

    University of Utah

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 3, 2008

Study Start

December 1, 2005

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

US(1)