Evaluation of a new model to predict scoliosis progression in adolescents
Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
This study is testing a new way to predict which teenagers with scoliosis are likely to have their condition get worse, so doctors can provide better treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 10 Years to 15 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital Academic / other |
| Locations | 9 sites (San Diego, California and 8 other locations) |
| Trial ID | NCT02434003 on ClinicalTrials.gov |
What this trial studies
This study aims to refine a predictive model for the progression of adolescent idiopathic scoliosis (AIS) by analyzing 3D spinal parameters. The model, developed from a cohort of 195 patients, seeks to identify those at significant risk of curve progression, allowing for proactive management strategies such as brace treatment. By distinguishing between patients who will progress and those who will not, the study aims to optimize treatment approaches and reduce unnecessary interventions. The research will involve multiple centers and will include patients with specific eligibility criteria related to their scoliosis condition.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10 and older diagnosed with idiopathic scoliosis, exhibiting specific curve measurements and skeletal maturity.
Not a fit: Patients with previous spinal surgeries, congenital or syndromic scoliosis, or other significant spinal abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this model could lead to more personalized treatment plans for adolescents with scoliosis, potentially reducing the need for surgical interventions.
How similar studies have performed: While similar predictive models have been explored, this specific approach utilizing 3D parameters is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Idiopathic Scoliosis (as diagnosed by the surgeon) * Patients above 10 year old at the time of recruitment * Spina bifida occulta with no neurological signs and otherwise normal * Curves ranging between 11º and 40º of Cobb angle measurement and * Risser 0 or 1, as measured on a standing postero-anterior digital radiograph of the spine. * All single thoracic, thoraco-lumbar, lumbar, double major and triple major curves will be included in the study. Exclusion Criteria: * Previous thoracic, pelvis or spine surgery as they may be co-factors in scoliosis initiation, * Congenital scoliosis, * MRI abnormalities (including \> 4mm of Syrinx and/or Chiari malformation) * Syndromic scoliosis (associated with Marfan's or other genetic syndromes), * Neuromuscular scoliosis, * Developmental delay * Spinal asymmetry * Symptomatic spondylolisthesis * Leg length discrepancy longer than 1 cm. * Unable or unwilling to firmly commit to returning for required follow-up visits
Where this trial is running
San Diego, California and 8 other locations
- Rady Children's Hospital — San Diego, California, United States (Recruiting)
- Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States (Not_yet_recruiting)
- Miami Children's Hospital — Miami, Florida, United States (Not_yet_recruiting)
- Mayo Clinic — Minneota, Minnesota, United States (Not_yet_recruiting)
- St Justine's Hospital — Montreal, Quebec, Canada (Recruiting)
- Robert Debré Hospital — Paris, France (Not_yet_recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- The Meijo Hospital — Nagoya, Japan (Recruiting)
- National University — Singapore, Singapore (Not_yet_recruiting)
Study contacts
- Principal investigator: Stefan Parent, MD, PhD — St. Justine's Hospital
- Study coordinator: Stefan Parent, MD, PhD
- Email: stefan.parent@umontreal.ca
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.