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Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis
Sponsor: Istituto Scientifico Italiano Colonna Vertebrale
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 title: Real-World Effectiveness and Validation of Prognostic Models in the Conservative Treatment of Spinal Deformities: a Retrospective Observational Study in a Cohort of 30,000 Patients
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
OBSERVATIONAL
Enrollment
30000
Start Date
2026-10-02
Completion Date
2029-10-02
Last Updated
2026-10-14
Healthy Volunteers
No
Interventions
Brace
Conservative treatment with a spinal brace (Sibilla, Lapadula, Sforzesco or PASB) prescribed during routine clinical practice, with personalised wear time. Prescribed and actual wear time (self-reported or measured with thermal sensors) are recorded. No intervention is assigned by the study.
Specific exercises (SEAS)
Physiotherapeutic Scoliosis-Specific Exercises according to the Scientific Exercises Approach to Scoliosis (SEAS) protocol, prescribed during routine clinical practice. No intervention is assigned by the study.
Locations (1)
ISICO - Italian Scientific Spine Institute
Milan, Italy