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OpenTrials
Completed

NCT Number: NCT03843216

End Growth Results for Conservative Treatment for Idiopahitc Scoliosis

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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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ISICO

Milan, Mi, 20141, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

patients not treated

Physiotherapic scoliosis specific exercise

Other

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

Brace

Device

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.

Primary outcomes

  1. Number of patients achieving specific results

    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.

Sponsors and collaborators

Lead sponsor

Istituto Scientifico Italiano Colonna Vertebrale

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2019
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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