Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— PCPS  

Official title:

Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00680264
• Other study ID #: 2007HSG021
• Status: Recruiting
• Start date: June 2008
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Setting Scoliosis Straight Foundation
• Contact: Michelle C. Marks, PT, MA
• Phone: 619-810-1430
• Email: mmarks[@]ssshsg.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical and non-operative treatment in patients with Cerebral Palsy.

Description:

Bracing severe neuromuscular scoliotic curves rarely serves as definitive treatment, thus most progressive curves require surgical intervention in order to sustain or improve sitting (or ambulatory) abilities. Surgery is a demanding intervention for these patients, with variable functional gains. Controversy persists regarding indications for surgery, timing, and technique. Concerns about complications are paramount. Previous neuromuscular studies have been confined to a small number of surgeons with a narrow range of surgical instrumentation, technique, and correction. Very little evidence exists regarding the impact spinal surgery on the quality of life in children with scoliosis related to cerebral palsy. The instruments to measure quality of life are not specific to children with scoliosis related to cerebral palsy. There have been no comprehensive prospective studies published. This study would be the first large-scale prospective, multi-center series of spinal fusion outcomes in patients with Cerebral Palsy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

• Patient age 8-21 years
• Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level
• Coronal Curve >50 degrees on sitting film (as measured by 'greatest Cobb') OR Kyphotic curve >70 degrees on sitting film (as measured by T5-T12) AND
• A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion). OR
• A spinal fusion is not being undertaken (Non-Operative cohort) either because the family has refused surgery or because it is not recommended at this point or surgery is recommended but is not being undertaken because they are on a waiting list, and are being enrolled as a non-op patient because they will be on the waiting list for >18 months.

Exclusion Criteria:

• Previous operated scoliotic spine deformity
• Diagnosis of Rett's Syndrome
• Concomitant lower extremity surgery (within 3 months of spinal fusion)

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Scoliosis

Locations

Country	Name	City	State
Canada	CHU Saint-Justine Hospital	Montreal
Canada	Hospital for Sick Children	Toronto
Canada	British Columbia Children's Hospital	Vancouver
United States	Johns Hopkins Medical Institute	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Kluge Children's Rehab. Ctr.	Charlottesville	Virginia
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Texas Scottish Rite Hospital	Dallas	Texas
United States	Miami Children's Hospital	Miami	Florida
United States	Columbia University	New York	New York
United States	New York University Hospital for Joint Diseases	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Shriners Hospital for Children	Philadelphia	Pennsylvania
United States	Rady Children's Hospital	San Diego	California
United States	A.I. Dupont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Setting Scoliosis Straight Foundation	K2M, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic outcomes		5 year
Secondary	Clinical outcomes		5 years
Secondary	Health related quality of life outcomes		5 years

External Links

•   Setting Scoliosis Straight Website - highlighting the research of the Harms Study Group