Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis
APOSIA
1 other identifier
observational
866
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2021
CompletedFirst Submitted
Initial submission to the registry
November 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 18, 2036
February 29, 2024
February 1, 2024
7 years
November 23, 2021
February 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Idiopathic scoliosis in adolescents requiring surgery
Interventions
Different questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10
Eligibility Criteria
Adolescents between 12 and 20 years old, suffering from scoliosis. Surgery has been proposed to them. 150 patients are French over the 866 patients.
You may qualify if:
- 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
You may not qualify if:
- Patient over 20 years old
- Non-surgical scoliosis
- Refusal to participate in the study by the child or parents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elsanlead
- European Clinical Trial Experts Networkcollaborator
- Asociación European Spine Study Groupcollaborator
Study Sites (1)
Clinique du dos
Bruges, 33520, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2021
First Posted
December 6, 2021
Study Start
March 18, 2021
Primary Completion (Estimated)
March 18, 2028
Study Completion (Estimated)
March 18, 2036
Last Updated
February 29, 2024
Record last verified: 2024-02