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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients achieving specific results | 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. | End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height. |
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Inclusion Criteria:
Exclusion Criteria:
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Scoliotic patients that were referred to a tertiary clinic specialized on spine deformity.
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Negrini, MD, Prof | stefano.negrini@isico.it | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISICO | Milan | Mi | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29435499 | Background | 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. | |
| 24047455 |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D001915 | Braces |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
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| Background |
| 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. |
| 29493563 | Background | 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. |
| 25780381 | Background | 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. |
| D013523 |
| Surgical Equipment |
| D004864 | Equipment and Supplies |