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

Recruitingn/aAges 10 Years - 15 YearsAllSt. Justine's Hospital
NCT02434003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Th

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

9 sites
Rady Children's Hospital
San Diego, United States
Alfred I. duPont Hospital for Children
Wilmington, United States
Miami Children's Hospital
Miami, United States
Mayo Clinic
Minneota, United States
St Justine's Hospital
Montreal, Canada
Robert Debré Hospital
Paris, France
Queen Mary Hospital
Hong Kong, Hong Kong
The Meijo Hospital
Nagoya, Japan

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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