Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Recruiting

• Conditions: Cerebral Palsy; Scoliosis

• Registration Number: NCT00680264
• Lead Sponsor: Setting Scoliosis Straight Foundation

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-20
• Study Start: 2008-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 402

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
radiographic outcomes	5 year

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	5 years
Health related quality of life outcomes	5 years

Trial Locations

Locations (15)

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

A.I. Dupont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Miami Children's Hospital; 🇺🇸 Miami, Florida, United States

Johns Hopkins Medical Institute; 🇺🇸 Baltimore, Maryland, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

New York University Hospital for Joint Diseases; 🇺🇸 New York, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Shriners Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States

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