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Prospective Study of Cerebral Palsy Scoliosis

This study has suspended participant recruitment.
(This study is coordinated by the Harms Study Group. It is already registered on this website)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00958542
First received: August 11, 2009
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Cerebral Palsy
Scoliosis
 Procedure: Surgical fusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Study of Scoliosis in Children With Cerebral Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Comparison of pre- and post- operative x-rays [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical Arm
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.
 Procedure: Surgical fusion
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.
No Intervention: Non-Surgical Arm
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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958542

Locations
Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Firoz Miyanji, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00958542     History of Changes
Other Study ID Numbers: H08-00897
Study First Received: August 11, 2009
Last Updated: January 11, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
cerebral palsy
scoliosis
children

Additional relevant MeSH terms:
Cerebral Palsy
Scoliosis
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013