The Pediatric Spine Foundation

Chest Wall and Spinal Disorders Clinical Trial

Official title:

The Pediatric Spine Foundation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02540915
• Other study ID #: 11-1248
• Status: Recruiting
• Start date: November 2013
• Est. completion date: December 2050

Study information

• Verified date: February 2023
• Source: University of Colorado, Denver
• Contact: Tyler Feddema, BS
• Phone: 720) 777-5809
• Email: tyler.feddema[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2050
• Est. primary completion date: December 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Wall and Spinal Disorders
• Spinal Diseases

Intervention

Other:
• Standard of Care - Registry
Standard of Care - Registry

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 10 years, recording each clinical and/or surgical visit the patient encounters at Children's Hospital Colorado.