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

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ClinicalTrials.gov Identifier: NCT00680264
Recruitment Status : Recruiting
First Posted : May 20, 2008
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
K2M, Inc.
Information provided by (Responsible Party):
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.

Condition or disease
Cerebral Palsy Scoliosis

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 Type : Observational
Estimated Enrollment : 402 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
Study Start Date : June 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Operative
Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level Curve >40 degrees on sitting film, A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion).
Non-operative
Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level, Curve >40 degrees on sitting film, A spinal fusion is not being undertaken either because the family has refused surgery or because it is not recommended at this point.



Primary Outcome Measures :
  1. radiographic outcomes [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Clinical outcomes [ Time Frame: 5 years ]
  2. Health related quality of life outcomes [ Time Frame: 5 years ]


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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680264


Contacts
Contact: Michelle C. Marks, PT, MA 619-810-1430 mmarks@ssshsg.org

Locations
United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Principal Investigator: Peter Newton, MD         
Sub-Investigator: Burt Yaszay, MD         
United States, Delaware
A.I. Dupont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Geraldine Neiss, PhD    302-651-6518    gneiss@nemours.org   
Principal Investigator: Suken Shah, MD         
United States, Florida
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Principal Investigator: Harry Shufflebarger, MD         
United States, Maryland
Johns Hopkins Medical Institute Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Paul Sponseller, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Mike Glotzbecker, MD         
United States, New York
New York University Hospital for Joint Diseases Recruiting
New York, New York, United States, 10003
Principal Investigator: Tom Errico, MD         
Columbia University Recruiting
New York, New York, United States, 10034
Principal Investigator: Michael Vitale, MD         
Sub-Investigator: Ben Roye, MD         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Peter Sturm, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Jack Flynn, MD         
Sub-Investigator: Pat Cahill, MD         
Shriners Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19140-4131
Sub-Investigator: Amer Samdani, MD         
United States, Texas
Texas Scottish Rite Hospital Recruiting
Dallas, Texas, United States, 75219
Principal Investigator: Dan Sucato, MD         
Sub-Investigator: Brandon Ramos, MD         
Sub-Investigator: Amy McIntosh, MD         
United States, Virginia
Kluge Children's Rehab. Ctr. Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Mark Abel, MD         
Sub-Investigator: Keith Bachmann, MD         
Canada
CHU Saint-Justine Hospital Recruiting
Montreal, Canada
Contact: Marjolaine Roy-Beaudry       marjolaine.beaudry@recherche-ste-justine.qc.ca   
Contact: Isabelle Turgeon       isabelle.turgeon@recherche-ste-justine.qc.ca   
Principal Investigator: Hubert Labelle, MD         
Sub-Investigator: Stefan Parent, MD         
Hospital for Sick Children Recruiting
Toronto, Canada
Principal Investigator: Unni G Narayanan, MBBS         
British Columbia Children's Hospital Recruiting
Vancouver, Canada
Principal Investigator: Chris Reilly, MD         
Sub-Investigator: Firoz Miyanji, MD         
Sponsors and Collaborators
Setting Scoliosis Straight Foundation
K2M, Inc.
Investigators
Principal Investigator: Paul Sponseller, MD John's Hopkins Hospital
Study Director: Peter Newton, MD Rady Children's Hospital San Deigo
Study Chair: Michelle Marks, PT, MA Harms Study Group

Additional Information:
Responsible Party: Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier: NCT00680264     History of Changes
Other Study ID Numbers: 2007HSG021
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by Setting Scoliosis Straight Foundation:
Treatment Outcomes
Scoliosis
Cerebral Palsy

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Scoliosis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases