Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
NCT ID: NCT00680264
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
402 participants
OBSERVATIONAL
2008-06-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Operative
Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level Curve \>40 degrees on sitting film, A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion).
No interventions assigned to this group
Non-operative
Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level, Curve \>40 degrees on sitting film, A spinal fusion is not being undertaken either because the family has refused surgery or because it is not recommended at this point.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Diagnosis of Rett's Syndrome
* Concomitant lower extremity surgery (within 3 months of spinal fusion)
8 Years
21 Years
ALL
No
Sponsors
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K2M, Inc.
INDUSTRY
Setting Scoliosis Straight Foundation
OTHER
Responsible Party
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Principal Investigators
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Paul Sponseller, MD
Role: PRINCIPAL_INVESTIGATOR
John's Hopkins Hospital
Peter Newton, MD
Role: STUDY_DIRECTOR
Rady Children's Hospital San Deigo
Michelle Marks, PT, MA
Role: STUDY_CHAIR
Harms Study Group
Locations
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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
Texas Scottish Rite Hospital
Dallas, Texas, United States
Kluge Children's Rehab. Ctr.
Charlottesville, Virginia, United States
CHU Saint-Justine Hospital
Montreal, , Canada
Hospital for Sick Children
Toronto, , Canada
British Columbia Children's Hospital
Vancouver, , Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group
Other Identifiers
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2007HSG021
Identifier Type: -
Identifier Source: org_study_id
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