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End Growth Results for Conservative Treatment for Idiopahitc Scoliosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03843216
Enrollment
1938
Registered
2019-02-18
Start date
2016-01-31
Completion date
2018-07-31
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis; Adolescence, Scoliosis Idiopathic

Brief summary

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

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.

Interventions

OTHERobservation

patients not treated

OTHERPhysiotherapic scoliosis specific exercise

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

DEVICEbrace

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.

Sponsors

Istituto Scientifico Italiano Colonna Vertebrale
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients achieving specific resultsEnd 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026