Registry of Scoliosis Outcomes in Children with Cerebral Palsy
Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
This study is trying to see how well different treatments for scoliosis work in children with cerebral palsy, including both surgery and non-surgical options, to help improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 402 (estimated) |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Sponsor | Setting Scoliosis Straight Foundation Academic / other |
| Locations | 15 sites (San Diego, California and 14 other locations) |
| Trial ID | NCT00680264 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the radiographic and clinical outcomes of both surgical and non-operative treatments for scoliosis in children diagnosed with cerebral palsy. It addresses the challenges of treating severe neuromuscular scoliosis, where surgery is often necessary but comes with significant risks and variable outcomes. By collecting data from multiple centers, this prospective registry seeks to provide comprehensive insights into the effectiveness of spinal fusion and its impact on quality of life for these patients. This is the first large-scale study of its kind, focusing on a population that has been underrepresented in previous research.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-21 years with total body involvement of cerebral palsy and significant scoliosis requiring surgical or non-operative intervention.
Not a fit: Patients with a previous operated scoliotic spine deformity or those with specific syndromes like Rett's Syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and quality of life for children with scoliosis related to cerebral palsy.
How similar studies have performed: While previous studies have been limited in scope, this approach is novel and aims to fill a significant gap in understanding treatment outcomes for this specific patient population.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
San Diego, California and 14 other locations
- Rady Children's Hospital — San Diego, California, United States (Recruiting)
- A.I. Dupont Hospital for Children — Wilmington, Delaware, United States (Recruiting)
- Miami Children's Hospital — Miami, Florida, United States (Recruiting)
- Johns Hopkins Medical Institute — Baltimore, Maryland, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- New York University Hospital for Joint Diseases — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Shriners Hospital for Children — Philadelphia, Pennsylvania, United States (Recruiting)
- Texas Scottish Rite Hospital — Dallas, Texas, United States (Recruiting)
- Kluge Children's Rehab. Ctr. — Charlottesville, Virginia, United States (Recruiting)
- CHU Saint-Justine Hospital — Montreal, Canada (Recruiting)
- Hospital for Sick Children — Toronto, Canada (Recruiting)
- British Columbia Children's Hospital — Vancouver, Canada (Recruiting)
Study contacts
- Principal investigator: Paul Sponseller, MD — John's Hopkins Hospital
- Study coordinator: Michelle C. Marks, PT, MA
- Email: mmarks@ssshsg.org
- Phone: 619-810-1430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.