End Growth Results for Conservative Treatment for Idiopahitc Scoliosis

NCT ID: NCT03843216

Last Updated: 2019-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1938 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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

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Scoliosis; Adolescence Scoliosis Idiopathic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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observation

patients not treated

Intervention Type OTHER

Physiotherapic scoliosis specific exercise

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

Intervention Type OTHER

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Scientifico Italiano Colonna Vertebrale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefano Negrini, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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ISICO

Milan, Mi, Italy

Site Status

Countries

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Italy

References

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Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

Reference Type BACKGROUND
PMID: 29435499 (View on PubMed)

Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.

Reference Type BACKGROUND
PMID: 24047455 (View on PubMed)

Di Felice F, Zaina F, Donzelli S, Negrini S. The Natural History of Idiopathic Scoliosis During Growth: A Meta-Analysis. Am J Phys Med Rehabil. 2018 May;97(5):346-356. doi: 10.1097/PHM.0000000000000861.

Reference Type BACKGROUND
PMID: 29493563 (View on PubMed)

Negrini S, Hresko TM, O'Brien JP, Price N; SOSORT Boards; SRS Non-Operative Committee. Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non-operative management committee. Scoliosis. 2015 Mar 7;10:8. doi: 10.1186/s13013-014-0025-4. eCollection 2015.

Reference Type BACKGROUND
PMID: 25780381 (View on PubMed)

Other Identifiers

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EGR-ISICO

Identifier Type: -

Identifier Source: org_study_id

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