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NCT05145725 Clinical Trial

Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

Scoliosis; Adolescence Clinical Trial

— APOSIA  

Official title:
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05145725
Other study ID # 2020-A03069-30
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 18, 2021
Est. completion date March 18, 2036

Study information
Verified date February 2024
Source Elsan
Contact Jean-François Oudet
Phone 0683346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months. The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 866
Est. completion date March 18, 2036
Est. primary completion date March 18, 2028
Accepts healthy volunteers No
Gender All
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria: - Patient between 12 and 20 years old - Scoliosis in adolescents for whom surgery has been proposed based on radiological criteria (Cobb angle> 25 ° for thoracolumbar and lumbar scoliosis,> 35 ° for thoracic scoliosis and> 40 ° for double major scoliosis) - Patient affiliated or beneficiary of a social security scheme or attached to a beneficiary of a social security scheme - Patient and legal representative having been informed and not opposing this research Exclusion Criteria: - Patient over 20 years old - Non-surgical scoliosis - Refusal to participate in the study by the child or parents

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Quality of life questionnaires
Different questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10

Locations
Country Name City State
France Clinique du dos Bruges

Sponsors (3)
Lead Sponsor Collaborator
Elsan Asociación European Spine Study Group, European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Factors associated with an improvement in the SRS-22r score Factors associated with an improvement in the SRS-22r score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in SRS-22r score is defined as an increase in the total score at 1 year of at least 10% from value. 1 year
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