Prospective Study of Cerebral Palsy Scoliosis

NCT00958542 | Suspended

• 1 other identifier: H08-00897
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

cerebral palsy; scoliosis; children

Outcome Measures

Primary Outcomes (1)

• Comparison of pre- and post- operative x-rays

  1 year

Secondary Outcomes (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

  1 year

Study Arms (2)

Surgical Arm

EXPERIMENTAL

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

Non-Surgical Arm

NO INTERVENTION

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.

Interventions

Surgical fusion 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.

Surgical Arm

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Scoliosis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Firoz Miyanji, Dr.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

CA (1)