Clinical trial NCT03843216: End Growth Results for Conservative Treatment for Idiopahitc Scoliosis
Official title: End-growth Results of Tailored Treatment in 1938 Adolescents With High Risk Idiopathic Scoliosis: a Cohort Study From a Prospective Clinical Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis; Adolescence
Scoliosis Idiopathic
Lead sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 1938
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scoliotic patients that were referred to a tertiary clinic specialized on spine deformity.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients achieving specific results
timeFrame: End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height.
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISICO
state: Mi
Study officials:
affiliation: stefano.negrini@isico.it
name: Stefano Negrini, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.