Prospective Study of Cerebral Palsy Scoliosis

University of British Columbia

Status: Suspended

Conditions: Cerebral Palsy; Scoliosis

Treatments: Procedure: Surgical fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00958542

H08-00897

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Surgical Arm

Experimental group

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.

Treatment:

Procedure: Surgical fusion

Non-Surgical Arm

No Intervention group

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.