Prospective Study of Cerebral Palsy Scoliosis

Cerebral Palsy Clinical Trial

Official title:

Prospective Study of Scoliosis in Children With Cerebral Palsy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00958542
• Other study ID #: H08-00897
• Status: Suspended
• Phase: N/A
• First received: August 11, 2009
• Last updated: June 20, 2014
• Start date: March 2009
• Est. completion date: June 2017

Study information

• Verified date: June 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cerebral Palsy
• Scoliosis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	BC Children's Hospital, Department of Orthopaedics	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of pre- and post- operative x-rays		1 year	No
Secondary	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	No