Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy (PCPS)

  • STATUS
    Recruiting
  • End date
    Dec 10, 2025
  • participants needed
    402
  • sponsor
    Setting Scoliosis Straight Foundation
Updated on 10 May 2022
scoliosis

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.

Details
Condition Cerebral Palsy, Scoliosis
Clinical Study IdentifierNCT00680264
SponsorSetting Scoliosis Straight Foundation
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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