Prospective Study of Cerebral Palsy Scoliosis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study of Scoliosis in Children With Cerebral Palsy

Conditions
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Cerebral Palsy, Scoliosis

Intervention / Treatment
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* Procedure: Surgical fusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical Arm<br>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<br>* 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.<br>|
| No Intervention: Non-Surgical Arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pre- and post- operative x-rays |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, scoliosis, children