End Growth Results for Conservative Treatment for Idiopahitc Scoliosis

Study Overview
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Brief Summary
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This study evaluates in a prospectively collected multicenter cohort the existence, characteristics and determinants of EBPCA, the obtained results and their determinant, the rate of over- and under-treatment and their determinants.

Detailed Description
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Since an evidence-based personalised conservative approach (EBPCA) to Adolescent Idiopathic Scoliosis has never been checked, the investigators studied a prospectively collected multicenter cohort with the aim to verify in the different clinical situations 1) the existence, characteristics and determinants of EBPCA; 2) the obtained results and their determinant; 3) the rate of over- and under-treatment and their determinants. These results are expected to check the actual evidence in everyday clinic, to provide a benchmark for future studies, and to inform guidelines producers and consequently health policy in high income countries, but also and particularly in low-middle income countries where surgery is difficult due to the high costs, and missing competences and structures.

Official Title
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End-growth Results of Tailored Treatment in 1938 Adolescents With High Risk Idiopathic Scoliosis: a Cohort Study From a Prospective Clinical Database

Conditions
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Scoliosis; Adolescence, Scoliosis Idiopathic

Intervention / Treatment
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* Other: observation
* Other: Physiotherapic scoliosis specific exercise
* Device: brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Adolescent Idiopathic Scoliosis (AIS), curves between 11 and 45° at start, Risser test between 0 and 2. Since our Institute receive many participants for a second opinion, we considered only participants in charge, defined as those who came at least three times to our facilities Exclusion Criteria: previous bracing; absence of x-rays in the 3 months before/after the start and the end of treatment/observation.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observation|patients not treated|
|Other: Physiotherapic scoliosis specific exercise|Specific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol|
|Device: brace|different kind of braces being elastic, rigid or very rigid. All devices are custom made. The hours of application per day varied from 18 to 24h.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients achieving specific results | Outcomes were calculated as number of patients achieving specific results at the end of growth, including: 1) remaining below the significant prognostic thresholds of 30° and 50°; 2) improved or progressed beyond the measurement error of 5°; 3) achieving the treatment aims proposed by the current Guidelines : primary (optimal) and secondary (minimal); 4) receiving under- or over-treatment, that have been defined during study planning in relationship to the ideal final result. | End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height. |