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The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical and non-operative treatment in patients with Cerebral Palsy.
Bracing severe neuromuscular scoliotic curves rarely serves as definitive treatment, thus most progressive curves require surgical intervention in order to sustain or improve sitting (or ambulatory) abilities. Surgery is a demanding intervention for these patients, with variable functional gains. Controversy persists regarding indications for surgery, timing, and technique. Concerns about complications are paramount. Previous neuromuscular studies have been confined to a small number of surgeons with a narrow range of surgical instrumentation, technique, and correction. Very little evidence exists regarding the impact spinal surgery on the quality of life in children with scoliosis related to cerebral palsy. The instruments to measure quality of life are not specific to children with scoliosis related to cerebral palsy. There have been no comprehensive prospective studies published. This study would be the first large-scale prospective, multi-center series of spinal fusion outcomes in patients with Cerebral Palsy.
Age
8 - 21 years
Sex
ALL
Healthy Volunteers
No
Rady Children's Hospital
San Diego, California, United States
A.I. Dupont Hospital for Children
Wilmington, Delaware, United States
Miami Children's Hospital
Miami, Florida, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
New York University Hospital for Joint Diseases
New York, New York, United States
Columbia University
New York, New York, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States
Start Date
June 1, 2008
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
November 21, 2023
402
ESTIMATED participants
Lead Sponsor
Setting Scoliosis Straight Foundation
Collaborators
NCT04630392
NCT06365892
NCT04761549
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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