NCT03843216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,938

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

September 25, 2018

Last Update Submit

February 13, 2019

Conditions

Scoliosis; AdolescenceScoliosis Idiopathic

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

observationOTHER

patients not treated

Physiotherapic scoliosis specific exerciseOTHER

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

braceDEVICE

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.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Scoliotic patients that were referred to a tertiary clinic specialized on spine deformity.

You may qualify if:

  • 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

You may not qualify if:

  • previous bracing;
  • absence of x-rays in the 3 months before/after the start and the end of treatment/observation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

Location

Related Publications (4)

  • 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.

    PMID: 29435499BACKGROUND

  • 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.

    PMID: 24047455BACKGROUND

  • 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.

    PMID: 29493563BACKGROUND

  • 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.

    PMID: 25780381BACKGROUND

MeSH Terms

Conditions

Scoliosis

Interventions

ObservationBraces

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Stefano Negrini, MD, Prof

    stefano.negrini@isico.it

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2018

First Posted

February 18, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

IT(1)