End Growth Results for Conservative Treatment for Idiopahitc Scoliosis

Istituto Scientifico Italiano Colonna Vertebrale1,938 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,938

Conditions

Scoliosis; Adolescence Scoliosis Idiopathic

Interventions

observationOTHER

patients not treated

Physiotherapic scoliosis specific exerciseOTHER

Specific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol

braceDEVICE

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

ISICO

Milan, Mi, Italy

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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