Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Status: Recruiting
Location: See all (15) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Rady Children's Hospital
RECRUITING
San Diego
Delaware
A.I. Dupont Hospital for Children
RECRUITING
Wilmington
Florida
Miami Children's Hospital
RECRUITING
Miami
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Maryland
Johns Hopkins Medical Institute
RECRUITING
Baltimore
New York
Columbia University
RECRUITING
New York
New York University Hospital for Joint Diseases
RECRUITING
New York
Ohio
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Shriners Hospital for Children
RECRUITING
Philadelphia
Texas
Texas Scottish Rite Hospital
RECRUITING
Dallas
Virginia
Kluge Children's Rehab. Ctr.
RECRUITING
Charlottesville
Other Locations
Canada
CHU Saint-Justine Hospital
RECRUITING
Montreal
Hospital for Sick Children
RECRUITING
Toronto
British Columbia Children's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Michelle C. Marks, PT, MA
mmarks@ssshsg.org
619-810-1430
Time Frame
Start Date: 2008-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 402
Treatments
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.
Authors
Harry Shufflebarger, Randal Betz, Patrick Cahill, Jean Ouellet
Sponsors
Leads: Setting Scoliosis Straight Foundation
Collaborators: K2M, Inc.

This content was sourced from clinicaltrials.gov