Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Purpose:

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.

Study summary:

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.

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)

Study is Available At:

Original ID:

2007HSG021

NCT ID:

NCT00680264

Secondary ID:

Study Acronym:

PCPS

Brief Title:

Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

Official Title:

Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT00680264

Overall Status:

Recruiting

Study Phase:

N/A

Genders:

N/A

Minimum Age:

8 Years

Maximum Age:

21 Years

Study Source:

Setting Scoliosis Straight Foundation

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:

Observational

Study Design:

Number of Arms:

0

Number of Groups:

2

Total Enrollment:

402

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: March 21, 2023

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