Aurora, Colorado 80045


Purpose:

The Chest Wall and Spine Deformity Registry is a tool designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders.


Study summary:

The Chest Wall and Spine Deformity Registry is a tool 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.


Criteria:

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 is Available At:


Original ID:

11-1248


NCT ID:

NCT02540915


Secondary ID:


Study Acronym:


Brief Title:

The Children's Spine Foundation and Study Group


Official Title:

The Children's Spine Foundation and Study Group


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

1200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Sumeet Garg, MD
Principal Investigator
Children's Hopsital Colorado
Primary Contact:Eun Bi Kim, BA
(720) 777-8062
eun.kim@childrenscolorado.org
Backup Contact:Thien Thanh Angela Vu, BS
720-777-5809
ThienThanhAngela.Vu@childrenscolorado.org

Study Dates

Start Date:November 2013
Completion Date:December 2021
Completion Type:Anticipated
Primary Completion Date:December 2021
Primary Completion Type:Anticipated
Verification Date:October 2019
Last Changed Date:October 15, 2019
First Received Date:August 26, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure: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 Chil
Safety Issues:False
Description: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 satu

Study Interventions

Intervention Type:Other
Name:Standard of Care - Registry
Description:Standard of Care - Registry
Arm Name:All patients 17 years or younger

Study Arms

Study Arm Type:Other
Arm Name:All patients 17 years or younger
Description:Standard of Care - Registry. Must have been 11 yrs or under at initial treatment/evaluation.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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