Prospective Study of Cerebral Palsy Scoliosis

NCT ID: NCT00958542

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2017-06-30

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.

Conditions

Cerebral Palsy; Scoliosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Surgical fusion

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Firoz Miyanji, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H08-00897

Identifier Type: -

Identifier Source: org_study_id