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RecruitingNCT02540915Updated Oct 10, 2024

The Pediatric Spine Foundation

An observational study in Chest Wall and Spinal Disorders, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
5,000
Ages
Up to 17 Years
Sex
All
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Study summary

The Pediatric Spine Foundation is a registry designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders.

Read the detailed description

The Pediatric Spine Foundation is a registry designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders. The registry allows spine surgeons to participate in retrospective and prospective studies for specific spinal disorders.

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Conditions studied

  • Chest Wall and Spinal Disorders

Browse trials for

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Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • Enrollment in another spine registry
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Study design

Observational model
Other
Time perspective
Other
Enrollment
5,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • All patients 17 years or younger

    Standard of Care - Registry. Must have been 11 yrs or under at initial treatment/evaluation.

    Other: Standard of Care - Registry

Interventions

  • OtherStandard of Care - Registry

    Standard of Care - Registry

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What researchers measure

Primary outcomes

  1. Clinical and radiographic measures for children with chest wall deformity, spine deformity and/or spinal disorder.

    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.

    Time frame: Approximately 10 years, recording each clinical and/or surgical visit the patient encounters at Children's Hospital Colorado.

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Study locations

1 of 1 sites recruiting
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Registry details

Key details

Study ID
NCT02540915
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Sep 4, 2015
Start date
Nov 2013
Primary completion
Dec 2050 (estimated)
Completion
Dec 2050 (estimated)
Last update
Oct 10, 2024

Study contacts

Tyler Feddema, BS
Contact
tyler.feddema@childrenscolorado.org
720) 777-5809
Florian Miller, BA
Contact
Florian.Miller@childrenscolorado.org
720) 777-8026
Sumeet Garg, MD
principal investigator · Children's Hopsital Colorado

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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