An observational study in Scoliosis; Adolescence and Scoliosis Idiopathic, sponsored by Istituto Scientifico Italiano Colonna Vertebrale. Completed at 1 site in Italy. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by Istituto Scientifico Italiano Colonna Vertebrale · Observational
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.
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 1,938 is above the median of 89 across 233 observational studies indexed under Scoliosis.
Browse Scoliosis studies →Istituto Scientifico Italiano Colonna Vertebrale is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Scoliotic patients that were referred to a tertiary clinic specialized on spine deformity.
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.
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.
Time frame: End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height.
Plan to share: Undecided
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istituto Scientifico Italiano Colonna Vertebrale