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Prospective Study of Cerebral Palsy Scoliosis

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ClinicalTrials.gov Identifier: NCT00958542
Recruitment Status : Suspended (This study is coordinated by the Harms Study Group. It is already registered on this website)
First Posted : August 13, 2009
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment
Cerebral Palsy Scoliosis Procedure: Surgical fusion

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study of Scoliosis in Children With Cerebral Palsy
Study Start Date : March 2009
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Comparison of pre- and post- operative x-rays [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00958542     History of Changes
Other Study ID Numbers: H08-00897
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

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

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