Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
- Conditions
- Cerebral PalsyScoliosis
- Registration Number
- NCT00680264
- Lead Sponsor
- Setting Scoliosis Straight Foundation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 402
- Patient age 8-21 years
- Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level
- Coronal Curve >50 degrees on sitting film (as measured by 'greatest Cobb') OR Kyphotic curve >70 degrees on sitting film (as measured by T5-T12) AND
- A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion).
OR
โข A spinal fusion is not being undertaken (Non-Operative cohort) either because the family has refused surgery or because it is not recommended at this point or surgery is recommended but is not being undertaken because they are on a waiting list, and are being enrolled as a non-op patient because they will be on the waiting list for >18 months.
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method radiographic outcomes 5 year
- Secondary Outcome Measures
Name Time Method Clinical outcomes 5 years Health related quality of life outcomes 5 years
Trial Locations
- Locations (15)
Texas Scottish Rite Hospital
๐บ๐ธDallas, Texas, United States
Children's Hospital of Philadelphia
๐บ๐ธPhiladelphia, Pennsylvania, United States
Shriners Hospital for Children
๐บ๐ธPhiladelphia, Pennsylvania, United States
Johns Hopkins Medical Institute
๐บ๐ธBaltimore, Maryland, United States
New York University Hospital for Joint Diseases
๐บ๐ธNew York, New York, United States
British Columbia Children's Hospital
๐จ๐ฆVancouver, Canada
Columbia University
๐บ๐ธNew York, New York, United States
CHU Saint-Justine Hospital
๐จ๐ฆMontreal, Canada
Hospital for Sick Children
๐จ๐ฆToronto, Canada
Kluge Children's Rehab. Ctr.
๐บ๐ธCharlottesville, Virginia, United States
Miami Children's Hospital
๐บ๐ธMiami, Florida, United States
Rady Children's Hospital
๐บ๐ธSan Diego, California, United States
Cincinnati Children's Hospital
๐บ๐ธCincinnati, Ohio, United States
A.I. Dupont Hospital for Children
๐บ๐ธWilmington, Delaware, United States
Boston Children's Hospital
๐บ๐ธBoston, Massachusetts, United States