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Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This retrospective observational study aims to assess the real-world effectiveness of conservative treatment (bracing and specific exercises) in patients with idiopathic scoliosis treated with an Evidence-Based Personalised Approach (EBPA). Clinical records of about 30,000 patients collected in the institutional database of ISICO (Italian Scientific Spine Institute, Milan, Italy) since 2003 will be analysed. For each patient, the expected natural history (risk of progression without treatment) will be estimated with two validated prognostic models, IS-GROWTH and BrAIST-Calc. The outcome observed at skeletal maturity will be compared with the predicted risk to measure treatment effectiveness in preventing the 30°, 45° and 50° Cobb thresholds. Secondary aims include subgroup analyses by age at onset (infantile, juvenile, adolescent), validation of the prognostic models in the Italian population, over- and under-treatment rates, drop-outs and compliance, quality of life of patients and parents, and comparison between treatment tools.
Trial Details
NCT Number NCT07873554
Lead Sponsor Istituto Scientifico Italiano Colonna Vertebrale
Conditions
(from sponsor)
Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis (AIS), Juvenile Idiopathic Scoliosis
Enrollment 30,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov