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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Setting Scoliosis Straight Foundation
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier:
NCT00680264
First received: May 16, 2008
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical treatment in patients with Cerebral Palsy.


Condition
Cerebral Palsy
Scoliosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study of Scoliosis in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Setting Scoliosis Straight Foundation:

Primary Outcome Measures:
  • radiographic outcomes [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Health related quality of life outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 402
Study Start Date: June 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680264

Contacts
Contact: Michelle C. Marks, PT, MA 520-529-2546 mmarks@comcast.net

Locations
United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: JoAnna Roocroft, BS    858-576-1700 ext 3186    jroocroft@rchsd.org   
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
Contact: Dianna Morales, MD    305-662-8346    dianna.morales@mch.com   
Principal Investigator: Harry Shufflebarger, MD         
Sub-Investigator: John Asghar, MD         
United States, Maryland
Johns Hopkins Medical Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jonsyhsn Preminger    401-502-6442    Jpreminger@jhu.edu   
Principal Investigator: Paul Sponseller, MD         
United States, Pennsylvania
Shriners Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19140-4131
Contact: Kim Costello, RN    215-430-4248    kcostello@shrinenet.org   
Sub-Investigator: Randal Betz, MD         
Sub-Investigator: Amer Samdani, MD         
Principal Investigator: Patrick Cahill, MD         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephanie Cody    215-590-1522    codys@email.chop.edu   
Principal Investigator: Jack Flynn, MD         
United States, Texas
Texas Scottish Rite Hospital Recruiting
Dallas, Texas, United States, 75219
Contact: Anna McClung, RN    214-559-7685    anna.mcclung@tsrh.org   
Principal Investigator: Dan Sucato, MD         
United States, Virginia
Kluge Children's Rehab. Ctr. Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Lindsay Sauer    434-924-5983    LKD4D@hscmail.mcc.virginia.edu   
Principal Investigator: Mark Abel, 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         
Children's Hospital Recruiting
Montreal, Canada
Principal Investigator: Jean Ouellet, MD, FRCSC         
Hospital for Sick Children Recruiting
Toronto, Canada
Principal Investigator: Unni G Narayanan, MBBS         
British Columbia Children's Hospital Recruiting
Vancouver, Canada
Contact: Veronika Scheepmaker    604-875-2359    VScheepmaker@cw.bc.ca   
Principal Investigator: Chris Reilly, MD         
Sub-Investigator: Firoz Miyanji, MD         
Sponsors and Collaborators
Setting Scoliosis Straight Foundation
DePuy Spine
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
  More Information

No publications provided

Responsible Party: Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier: NCT00680264     History of Changes
Other Study ID Numbers: 2007HSG021
Study First Received: May 16, 2008
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014