NCT03843216

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
• Phase: —
• Study type: Observational
• Enrollment: 1,938 (actual)
• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis; Adolescence
• Scoliosis Idiopathic

Interventions

Type	Name	Description
OTHER	observation	patients not treated
OTHER	Physiotherapic scoliosis specific exercise	Specific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol
DEVICE	brace	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-01-01
• Completion: 2018-07-01
• First posted: 2019-02-18
• Last updated: 2019-02-18

Locations

1 site across 1 country: Italy