Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy



Status:Recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:8 - 21
Updated:4/17/2018
Start Date:June 2008
End Date:December 2020
Contact:Michelle C. Marks, PT, MA
Email:mmarks@ssshsg.org
Phone:619-810-1430

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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.

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.

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)
We found this trial at
13
sites
Wilmington, Delaware 19803
Principal Investigator: Suken Shah, MD
Phone: 302-651-6518
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Principal Investigator: Harry Shufflebarger, MD
Phone: 305-662-8346
Miami Children's Hospital Welcome to Miami Children
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Michael Vitale, MD
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Jack Flynn, MD
Phone: 215-590-1522
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Baltimore, Maryland 21287
Principal Investigator: Paul Sponseller, MD
Phone: 401-502-6442
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Mike Glotzbecker, MD
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Charlottesville, Virginia 22908
Principal Investigator: Mark Abel, MD
Phone: 434-924-5983
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Charlottesville, VA
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Cincinnati, Ohio 45229
Principal Investigator: Peter Sturm, MD
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Cincinnati, OH
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Dallas, Texas 75219
Principal Investigator: Dan Sucato, MD
Phone: 214-559-7685
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Dallas, TX
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Montreal,
Principal Investigator: Hubert Labelle, MD
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Montreal,
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New York, New York 10003
Principal Investigator: Tom Errico, MD
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Philadelphia, Pennsylvania 19140
Phone: 215-430-4248
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San Diego, California 92123
Principal Investigator: Peter Newton, MD
Phone: 858-576-1700
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San Diego, CA
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