Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT02434003

Conditions

Scoliosis

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Scoliosis

Study ID

NCT02434003

Start date

May, 2014

Status verified date

Apr, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]

Central Contacts and Locations

Central contacts

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Peter Newton, MD

pnewton@chsd.org

St Justine's Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1C4

Contacts

Stefan Parent, MD, PhD

stefan.parent@umontreal.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2024-04-17.