Clinical trial NCT00680264: Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
Official title: Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Scoliosis
Keywords: Treatment Outcomes
Scoliosis
Cerebral Palsy
Lead sponsor: Setting Scoliosis Straight Foundation
Sponsor class: OTHER
Collaborators: name: K2M, Inc.
First posted: 2008-05-20
Enrollment: 402
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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 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)

Primary outcomes:
measure: radiographic outcomes
timeFrame: 5 year
Secondary outcomes:
measure: Clinical outcomes
timeFrame: 5 years
measure: Health related quality of life outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Wilmington
country: United States
facility: A.I. Dupont Hospital for Children
state: Delaware
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institute
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Shriners Hospital for Children
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital
state: Texas
city: Charlottesville
country: United States
facility: Kluge Children's Rehab. Ctr.
state: Virginia
city: Montreal
country: Canada
facility: CHU Saint-Justine Hospital
city: Toronto
country: Canada
facility: Hospital for Sick Children
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
Study officials:
affiliation: John's Hopkins Hospital
name: Paul Sponseller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rady Children's Hospital San Deigo
name: Peter Newton, MD
role: STUDY_DIRECTOR
affiliation: Harms Study Group
name: Michelle Marks, PT, MA
role: STUDY_CHAIR
References: