Prospective Study of Cerebral Palsy Scoliosis

Not Applicable

Suspended

• Conditions: Cerebral Palsy; Scoliosis
• Interventions: Procedure: Surgical fusion

• Registration Number: NCT00958542
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Arm	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.

Primary Outcome Measures

Name	Time	Method
Comparison of pre- and post- operative x-rays	1 year

Secondary Outcome Measures

Name	Time	Method
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	1 year

Trial Locations

Locations (1)

BC Children's Hospital, Department of Orthopaedics; 🇨🇦 Vancouver, British Columbia, Canada