Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
1 other identifier
observational
1,200
6 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 17, 2024
April 1, 2024
13.6 years
April 18, 2015
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in scoliosis severity based on the 3D reconstruction of the spine at the initial visit and follow ups in a large multicenter prospective study
The main objective of this study is to validate a predictive model for determining scoliosis severity based on the 3D reconstruction of the spine at the initial visit in a large multicenter prospective study. This objective can be divided in two specific objectives: Objective 1: to improve the determination coefficient of the predictive model by including new findings of a subset of this prospective cohort of patients. Objective 2: to test the external validity of the predictive model
Baseline, 6 months, 12 months, 18 months, 24 months
Eligibility Criteria
A total of 1200 patients will be recruited from the scoliosis clinic at eight (8) tertiary care facilities located around the world. All consecutive patients seen at these clinics will be screened for the presence of scoliosis first by clinical examination and followed by radiographic confirmation using the EOS™ system.
You 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Justine's Hospitallead
- Queen Mary Hospital, Hong Kongcollaborator
- The Meijo Hospital, Nagoya, Japancollaborator
- National University of Singaporecollaborator
- Hopital Universitaire Robert-Debrecollaborator
- Alfred I. duPont Hospital for Childrencollaborator
- Nicklaus Children's Hospital f/k/a Miami Children's Hospitalcollaborator
- Rady Children's Hospital, San Diegocollaborator
Study Sites (9)
Rady Children's Hospital
San Diego, California, 92123, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Mayo Clinic
Minneota, Minnesota, MN 55902, United States
St Justine's Hospital
Montreal, Quebec, H3T 1C4, Canada
Robert Debré Hospital
Paris, 75019, France
Queen Mary Hospital
Hong Kong, Hong Kong
The Meijo Hospital
Nagoya, Japan
National University
Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Parent, MD, PhD
St. Justine's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic surgeon
Study Record Dates
First Submitted
April 18, 2015
First Posted
May 5, 2015
Study Start
May 1, 2014
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 17, 2024
Record last verified: 2024-04