ISICO
Milan, Mi, 20141, Italy
NCT Number: NCT03843216
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.
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Notify Me10 year–18 year
All sexes
Observational
Milan, Mi, 20141, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients not treated
Specific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol
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.
Time frame: End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height.
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.
Istituto Scientifico Italiano Colonna Vertebrale
Other
End-growth Results of Tailored Treatment in 1938 Adolescents With High Risk Idiopathic Scoliosis: a Cohort Study From a Prospective Clinical Database
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