Back to resultsProspective Study of Cerebral Palsy Scoliosis
Primary Purpose
Cerebral Palsy, Scoliosis
Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Surgical fusion
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Palsy focused on measuring cerebral palsy, scoliosis, children
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 8 and 18 years
- Diagnosis of Cerebral Palsy with total body involvement
- Coronal curve greater than 40 degrees OR a kyphotic curve greater than 50 degrees on sitting film will be included
- Growing rod treatment will also be included
Exclusion Criteria:
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
- Cornelia de Lange Syndrome or any pervasive genetic disorder whose effects are due to much more than the static cortical injury
- Ambulatory spastic diplegic without upper extremity impairment or speech, swallowing or other involvement
Sites / Locations
- BC Children's Hospital, Department of Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Surgical Arm
Non-Surgical Arm
Arm Description
Surgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon.
Non-Surgical No intervention - Includes patients who have either refused to have surgery or have not been recommended to have surgery at this point. These patients will continue to be monitored closely, however, will not receive any other intervention.
Outcomes
Primary Outcome Measures
Comparison of pre- and post- operative x-rays
Secondary Outcome Measures
Gross motor function, physical data, past medical history, seizure status, pain and medications, sitting ability, activity level, clinical photos, quality of life questionnaires, data regarding surgery and hospital stay
Full Information
NCT ID
NCT00958542
First Posted
August 11, 2009
Last Updated
June 20, 2014
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00958542
Brief Title
Prospective Study of Cerebral Palsy Scoliosis
Official Title
Prospective Study of Scoliosis in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Suspended
Why Stopped
This study is coordinated by the Harms Study Group. It is already registered on this website
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, multi-centre study that will be looking at two groups of males and females over the course of their operative treatment for cerebral palsy (CP) scoliosis and the years following that treatment. The first group the study will be looking at is those individuals who undergo surgery for CP Scoliosis. The second group will be those individuals who do not undergo surgical treatment for CP Scoliosis, either because the family declines surgery or surgery is not recommended during the course of study participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Scoliosis
Keywords
cerebral palsy, scoliosis, children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical Arm
Arm Type
Experimental
Arm Description
Surgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon.
Arm Title
Non-Surgical Arm
Arm Type
No Intervention
Arm Description
Non-Surgical No intervention - Includes patients who have either refused to have surgery or have not been recommended to have surgery at this point. These patients will continue to be monitored closely, however, will not receive any other intervention.
Intervention Type
Procedure
Intervention Name(s)
Surgical fusion
Intervention Description
Surgical intervention for correction of scoliotic or kyphotic curvatures of the spine will include either the posterior approach or the anterior + posterior approach, with either the unit or custom rod, depending on the choice of the surgeon.
Primary Outcome Measure Information:
Title
Comparison of pre- and post- operative x-rays
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Gross motor function, physical data, past medical history, seizure status, pain and medications, sitting ability, activity level, clinical photos, quality of life questionnaires, data regarding surgery and hospital stay
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 8 and 18 years
Diagnosis of Cerebral Palsy with total body involvement
Coronal curve greater than 40 degrees OR a kyphotic curve greater than 50 degrees on sitting film will be included
Growing rod treatment will also be included
Exclusion Criteria:
Previous operated scoliotic spine deformity
Diagnosis of Rett's Syndrome
Concomitant lower extremity surgery (within 3 months of spinal fusion)
Cornelia de Lange Syndrome or any pervasive genetic disorder whose effects are due to much more than the static cortical injury
Ambulatory spastic diplegic without upper extremity impairment or speech, swallowing or other involvement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firoz Miyanji, Dr.
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital, Department of Orthopaedics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Prospective Study of Cerebral Palsy Scoliosis
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