Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 15
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Rady Children's Hospital
RECRUITING
San Diego
Delaware
Alfred I. duPont Hospital for Children
NOT_YET_RECRUITING
Wilmington
Florida
Miami Children's Hospital
NOT_YET_RECRUITING
Miami
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Minneota
Other Locations
Canada
St Justine's Hospital
RECRUITING
Montreal
France
Robert Debré Hospital
NOT_YET_RECRUITING
Paris
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Japan
The Meijo Hospital
RECRUITING
Nagoya
Singapore
National University
NOT_YET_RECRUITING
Singapore
Contact Information
Primary
Stefan Parent, MD, PhD
stefan.parent@umontreal.ca
Backup
Marjolaine Roy-Beaudry
marjolaine.roy-beaudry.hsj@ssss.gouv.qc.ca
Time Frame
Start Date: 2014-05
Estimated Completion Date: 2027-12
Participants
Target number of participants: 1200
Sponsors
Collaborators: Queen Mary Hospital, Hong Kong, Hopital Universitaire Robert-Debre, Alfred I. duPont Hospital for Children, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, National University of Singapore, The Meijo Hospital, Nagoya, Japan, Rady Children's Hospital, San Diego
Leads: St. Justine's Hospital

This content was sourced from clinicaltrials.gov