NCT05145725 Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis
| NCT ID | NCT05145725 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elsan |
| Condition | Scoliosis; Adolescence |
| Study Type | OBSERVATIONAL |
| Enrollment | 866 participants |
| Start Date | 2021-03-18 |
| Primary Completion | 2028-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 866 participants in total. It began in 2021-03-18 with a primary completion date of 2028-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05145725 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 20 Years, studying Scoliosis; Adolescence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05145725 currently recruiting?
Yes, NCT05145725 is actively recruiting participants. Contact the research team at jf.oudet@ecten.eu for enrollment information.
Where is the NCT05145725 trial being conducted?
This trial is being conducted at Bruges, France.
Who is sponsoring the NCT05145725 clinical trial?
NCT05145725 is sponsored by Elsan. The trial plans to enroll 866 participants.