Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Sumeet Garg, MD
CONTACT
Sumeet Garg, MD
CONTACT
Thien Thanh Angela Vu, BS
CONTACT
Recruiting
NCT Number: NCT02540915
The Pediatric Spine Foundation
The Pediatric Spine Foundation is a registry designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
Up to 17 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
- Enrollment in another spine registry
Treatment and study plan
Standard of Care - Registry
OtherStandard of Care - Registry
Primary outcomes
-
Clinical and radiographic measures for children with chest wall deformity, spine deformity and/or spinal disorder.
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Florian Miller, BA
CONTACT
Tyler Feddema, BS
CONTACT
Sponsors and collaborators
Lead sponsor
University of Colorado, Denver
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2050
- Study completion
- 2050
- First posted
- Sep 4, 2015
- Registry last updated
- Oct 10, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.