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.

Study Overview

• Status: Recruiting
• Conditions: Chest Wall and Spinal Disorders
• Intervention / Treatment: Other: Standard of Care - Registry

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Tyler Feddema, BS; Phone Number: 720) 777-5809; Email: tyler.feddema@childrenscolorado.org
• Study Contact Backup: Name: Florian Miller, BA; Phone Number: 720) 777-8026; Email: Florian.Miller@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Sumeet Garg, MD; Phone Number: 720-777-3253; Email: sumeet.garg@childrenscolorado.org
      • Contact: Thien Thanh Angela Vu, BS; Phone Number: 720) 777-5809; Email: ThienThanhAngela.Vu@childrenscolorado.org
      • Contact: Sumeet Garg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Standard of Care - Registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Sumeet Garg, MD, Children's Hopsital Colorado

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimated): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: 11-1248