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The Pediatric Spine Foundation

The Pediatric Spine Foundation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02540915
Enrollment
5000
Registered
2015-09-04
Start date
2013-11-30
Completion date
2050-12-31
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Wall and Spinal Disorders

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.

Interventions

OTHERStandard of Care - Registry

Standard of Care - Registry

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

United States

Contacts

Primary ContactTyler Feddema, BS
tyler.feddema@childrenscolorado.org720) 777-5809
Backup ContactFlorian Miller, BA
Florian.Miller@childrenscolorado.org720) 777-8026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026