RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2014-05
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02434003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Idiopathic Scoliosis (as diagnosed by the surgeon)
  2. * Patients above 10 year old at the time of recruitment
  3. * Spina bifida occulta with no neurological signs and otherwise normal
  4. * Curves ranging between 11º and 40º of Cobb angle measurement and
  5. * Risser 0 or 1, as measured on a standing postero-anterior digital radiograph of the spine.
  6. * All single thoracic, thoraco-lumbar, lumbar, double major and triple major curves will be included in the study.
  1. * Previous thoracic, pelvis or spine surgery as they may be co-factors in scoliosis initiation,
  2. * Congenital scoliosis,
  3. * MRI abnormalities (including \> 4mm of Syrinx and/or Chiari malformation)
  4. * Syndromic scoliosis (associated with Marfan's or other genetic syndromes),
  5. * Neuromuscular scoliosis,
  6. * Developmental delay
  7. * Spinal asymmetry
  8. * Symptomatic spondylolisthesis
  9. * Leg length discrepancy longer than 1 cm.
  10. * Unable or unwilling to firmly commit to returning for required follow-up visits

Contacts and Locations

Study Contact

Stefan Parent, MD, PhD
CONTACT
stefan.parent@umontreal.ca
Marjolaine Roy-Beaudry
CONTACT
marjolaine.roy-beaudry.hsj@ssss.gouv.qc.ca

Principal Investigator

Stefan Parent, MD, PhD
PRINCIPAL_INVESTIGATOR
St. Justine's Hospital

Study Locations (Sites)

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
Minnesota, Minnesota, MN 55902
United States

Collaborators and Investigators

Sponsor: St. Justine's Hospital

  • Stefan Parent, MD, PhD, PRINCIPAL_INVESTIGATOR, St. Justine's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-05
Study Completion Date2027-12

Study Record Updates

Study Start Date2014-05
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • 3D reconstruction
  • AIS
  • Computer models
  • Spinal Deformity

Additional Relevant MeSH Terms

  • Scoliosis