What this study is
Scoliosis is a three-dimensional deformity affecting the orientation and position of the spine. Locally, the shape of the vertebra is also affected. The most common form is adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young adolescent females. AIS can either be treated using a brace and in some cases necessitate surgical correction to prevent progressive deformity. Risk factors for progression include female gender, curve magnitude and location, skeletal maturity and growth velocity. However, these risk factors have been shown to be inconsistent in predicting curve progression. Over the past 6 years, the investigators have developed a predictive model of the final Cobb angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195 patients that were enrolled upon their initial visit and followed until maturity. This predictive model has a determination coefficient of 0.702. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study. The objective of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. Three-dimensional reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral disks at each level as well as the geometry of the pelvis. A series of local and regional parameters will then be calculated from these 3D reconstructions. Correlation analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation or pelvic geometry can be used as early predictors of curve progression in AIS.
Identifying a new 3D measure of scoliosis associated with rapid curve progression could help predict which curves need early treatment to prevent further progression. The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.
Study details
- Sponsor
- St. Justine's Hospital
- Conditions
- Scoliosis
- Enrolling
- 1,200 people
- Starts
- 2014-05
- Est. completion
- 2027-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years – 15 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openRady Children's Hospital
San Diego, California, United States
- Peter Newton, MD · Contactpnewton@chsd.org
RecruitingAlfred I. duPont Hospital for Children
Wilmington, Delaware, United States
- Suken Shah · Contactsshah@nemours.org
Not yet recruitingMiami Children's Hospital
Miami, Florida, United States
- Harry Shufflebarger, MD · Contacththook@aol.com
Not yet recruitingMayo Clinic
Minneota, Minnesota, United States
- Noelle Larson · Contact
- Smitha Mathew · ContactMathew.Smitha@mayo.edu
Not yet recruiting
5 sites outside the US
St Justine's Hospital
Montreal, Quebec, Canada
- Stefan Parent, MD, PhD · Contactstefan.parent@umontreal.ca
Recruiting- Not yet recruiting
- Recruiting
- Recruiting
- Not yet recruiting
Study team
Sponsor
St. Justine's Hospital
Study ID 3896
Principal investigator
Stefan Parent, MD, PhD
St. Justine's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.