The Pediatric Spine Foundation

Recruiting

• Conditions: Chest Wall and Spinal Disorders
• Interventions: Other: Standard of Care - Registry

• Registration Number: NCT02540915
• Lead Sponsor: University of Colorado, Denver

Brief 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.

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2050-12
• Study Completion: 2050-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients 17 years or younger	Standard of Care - Registry	Standard of Care - Registry. Must have been 11 yrs or under at initial treatment/evaluation.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States