The Pediatric Spine Foundation Registry for Chest Wall and Spinal Disorders

This study is a registry called The Pediatric Spine Foundation. It collects information on children with chest wall (the bony and cartilaginous cage around the lungs) and spinal disorders. The registry helps spine surgeons track patients and participate in studies. You can join if you are 17 or younger and are being treated at Children's Hospital Colorado Orthopaedic department for a chest wall or spinal disorder. You must have been 11 or younger at your first treatment or evaluation there. The study will look at clinical and X-ray (radiographic) measurements over about 10 years to understand how these conditions progress and are treated. This is an observational study, meaning researchers will collect information without giving new treatments.

Study design
This is an observational study designed to enroll 5000 participants. It is a registry, which means it collects information over time.
What's involved
The study collects information at each clinical and/or surgical visit you have at Children's Hospital Colorado.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 10 years, with data recorded at each clinical and/or surgical visit.

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NCT02540915

The Pediatric Spine Foundation

Recruiting
Not specifiedUp to 17Observational
University of Colorado, Denver
~5,000 participants
Updated 2024-10-10 on ClinicalTrials.gov
What's tested:Standard of Care - Registry

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical and radiographic measures for children with chest wall deformity, spine deformity and/or spinal disorder.
Measured over Approximately 10 years, recording each clinical and/or surgical visit the patient encounters at Children's Hospital Colorado.
Chest Wall and Spinal Disorders
1 sites across 1 states
Colorado1
  • Sumeet Garg, MD · PRINCIPAL_INVESTIGATOR · Children's Hopsital Colorado

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Eligibility criteria

Inclusion

All patients 17 and under that are being treated at Children's Hospital Colorado Orthopaedic department for a chest wall deformity, spine deformity and/or spinal disorder. However, patients must be/have been 11 or under at their initial treatment/evaluation at Children's Hospital Colorado to be included in this study.

Exclusion

Enrollment in another spine registry
  • Clinical and radiographic measures for children with chest wall deformity, spine deformity and/or spinal disorder.Approximately 10 years, recording each clinical and/or surgical visit the patient encounters at Children's Hospital Colorado.

    The registry records data from clinical and surgical visits - evaluation date, demographics, cobb angle, kyphosis, ambulatory status, ECG and ECHO measurements, lab results (HbG, Serum CO2, Albumin, Prealbumin), X-rays, pulmonary function test and O2 saturation, primary diagnosis, comorbidities, prior and current treatment, surgical info (days in ICU, blood loss, type of procedure, position of device, fusion details), and complication details. An Early Onset Scoliosis 24-Item Questionnaire is also administered each visit. Questions pertain to general health, pain/discomfort, pulmonary function, transfer, physical function, daily living, energy level, emotion, parental impact, financial impact, and satisfaction. For each category there are 1-3 questions where parents can circle one of the five answer choices that vary in severity grade. The primary outcome would be to complete numerous small retrospective cohort studies using the data collected prospectively from the registry.