Status:
COMPLETED
The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
Lead Sponsor:
Growing Spine Study Group
Collaborating Sponsors:
Growing Spine Foundation
Conditions:
Early Onset Scoliosis
Congenital Spinal Deformities
Eligibility:
All Genders
1-18 years
Brief Summary
The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices...
Detailed Description
This multi-center study will evaluate the long-term clinical and radiographic outcomes of Early Onset Scoliosis (EOS) and other Early Onset Spinal and Chest Wall Deformities in a large population of p...
Eligibility Criteria
Inclusion
- Patients of any age and any diagnosis who undergo a growth-friendly surgical procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid constructs, spinal tethering and staples
- Patients of any age and any diagnosis who undergo casting
- Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the thoracic and/or lumbar spine
- Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic and/or lumbar spine measuring \> 25 degrees. Observed and braced patients included
Exclusion
- Cervical spine anomalies alone will not be included
- Patient/family is unwilling to participate in the study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2020
Estimated Enrollment :
2602 Patients enrolled
Trial Details
Trial ID
NCT02299362
Start Date
October 1 2008
End Date
February 4 2020
Last Update
February 6 2020
Active Locations (27)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Rady Children's Hospital
San Diego, California, United States, 92123
4
Nemours/Alfred I. Dupont Hospital for Children
Wilmington, Delaware, United States, 19899