Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Status unconfirmed

Conditions studied: Cerebral Palsy, Scoliosis

In brief

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.

Key facts

Study ID

NCT00680264

Run by

Setting Scoliosis Straight Foundation

People needed

402

Starts

2008-06-01

Expected to finish

2025-12-01

Last updated by the study team

2023-11-21

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• Previous operated scoliotic spine deformity
• Diagnosis of Rett's Syndrome
• Concomitant lower extremity surgery (within 3 months of spinal fusion)

Where it is running

• Rady Children's Hospital — San Diego, California, United States (enrolling)
• A.I. Dupont Hospital for Children — Wilmington, Delaware, United States (enrolling)
• Miami Children's Hospital — Miami, Florida, United States (enrolling)
• Johns Hopkins Medical Institute — Baltimore, Maryland, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• New York University Hospital for Joint Diseases — New York, New York, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Shriners Hospital for Children — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Scottish Rite Hospital — Dallas, Texas, United States (enrolling)
• Kluge Children's Rehab. Ctr. — Charlottesville, Virginia, United States (enrolling)
• CHU Saint-Justine Hospital — Montreal, Canada (enrolling)
• Hospital for Sick Children — Toronto, Canada (enrolling)
• British Columbia Children's Hospital — Vancouver, Canada (enrolling)

Full record on ClinicalTrials.gov

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