End Growth Results for Conservative Treatment for Idiopahitc Scoliosis

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843216
• Other study ID #: EGR-ISICO
• Status: Completed
• Start date: January 2016
• Est. completion date: July 2018

Study information

• Verified date: February 2019
• Source: Istituto Scientifico Italiano Colonna Vertebrale
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1938
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence

Intervention

Other:
• observation
patients not treated
• 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.

Locations

Country	Name	City	State
Italy	ISICO	Milan	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Italiano Colonna Vertebrale

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.