Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
PCPS
1 other identifier
observational
402
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 21, 2023
November 1, 2023
17.5 years
May 16, 2008
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
radiographic outcomes
5 year
Secondary Outcomes (2)
Clinical outcomes
5 years
Health related quality of life outcomes
5 years
Study Arms (2)
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).
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.
Eligibility Criteria
Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
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).
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Setting Scoliosis Straight Foundationlead
- K2M, Inc.collaborator
Study Sites (15)
Rady Children's Hospital
San Diego, California, 92123, United States
A.I. Dupont Hospital for Children
Wilmington, Delaware, 19803, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
New York University Hospital for Joint Diseases
New York, New York, 10003, United States
Columbia University
New York, New York, 10034, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140-4131, United States
Texas Scottish Rite Hospital
Dallas, Texas, 75219, United States
Kluge Children's Rehab. Ctr.
Charlottesville, Virginia, 22908, United States
CHU Saint-Justine Hospital
Montreal, Canada
Hospital for Sick Children
Toronto, Canada
British Columbia Children's Hospital
Vancouver, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Sponseller, MD
John's Hopkins Hospital
- STUDY DIRECTOR
Peter Newton, MD
Rady Children's Hospital San Deigo
- STUDY CHAIR
Michelle Marks, PT, MA
Harms Study Group
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 20, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
November 21, 2023
Record last verified: 2023-11