Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Last updated: November 20, 2023
Sponsor: Setting Scoliosis Straight Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Cataplexy

Treatment

N/A

Clinical Study ID

NCT00680264
2007HSG021
  • Ages 8-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient age 8-21 years
  • Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of
  1. with total body involvement - any functional level
  • Coronal Curve >50 degrees on sitting film (as measured by 'greatest Cobb') OR Kyphoticcurve >70 degrees on sitting film (as measured by T5-T12) AND
  • A spinal fusion is being undertaken and the patient/family is proceeding with thespinal fusion (with any level of distal fusion). OR

• A spinal fusion is not being undertaken (Non-Operative cohort) either because the familyhas refused surgery or because it is not recommended at this point or surgery isrecommended but is not being undertaken because they are on a waiting list, and are beingenrolled as a non-op patient because they will be on the waiting list for >18 months.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 402
Study Start date:
June 01, 2008
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • CHU Saint-Justine Hospital

    Montreal,
    Canada

    Active - Recruiting

  • Hospital for Sick Children

    Toronto,
    Canada

    Active - Recruiting

  • British Columbia Children's Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • Rehabilitationskrankenhaus Lagensteinbach

    Karlsbad-Lagensteinbach,
    Germany

    Site Not Available

  • Rady Children's Hospital

    San Diego, California 92123
    United States

    Active - Recruiting

  • A.I. Dupont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Active - Recruiting

  • Miami Children's Hospital

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Johns Hopkins Medical Institute

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10034
    United States

    Active - Recruiting

  • New York University Hospital for Joint Diseases

    New York, New York 10003
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Shriners Hospital for Children

    Philadelphia, Pennsylvania 19140-4131
    United States

    Active - Recruiting

  • Texas Scottish Rite Hospital

    Dallas, Texas 75219
    United States

    Active - Recruiting

  • Kluge Children's Rehab. Ctr.

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

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