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Clinical Trial

Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis

NCT: NCT07873554 · ACTIVE_NOT_RECRUITING

NCT IDNCT07873554
StatusACTIVE_NOT_RECRUITING
Start Date2026-10-02
Completion2029-10-02
SponsorIstituto Scientifico Italiano Colonna Vertebrale (OTHER)
First posted
Last updated

Brief Summary

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.

Official Source

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