Research on quality of life improvements after scoliosis surgery in adolescents
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study
This study is trying to see how scoliosis surgery affects the quality of life for teenagers aged 12 to 20 and what factors might help them feel better afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 866 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT05145725 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adolescent patients aged 12 to 20 who have been diagnosed with idiopathic scoliosis and are awaiting surgical intervention. The research aims to identify predictive factors that may influence improvements in the quality of life following surgery. Participants will complete quality of life questionnaires to assess their experiences and outcomes post-surgery. The study is designed to gather insights that could enhance future treatment approaches for scoliosis in adolescents.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 20 with idiopathic scoliosis requiring surgical intervention based on specific radiological criteria.
Not a fit: Patients over 20 years old or those with non-surgical scoliosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into factors that improve quality of life for adolescents undergoing scoliosis surgery.
How similar studies have performed: While there have been studies on scoliosis surgery outcomes, this specific focus on quality of life improvements in adolescents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bruges
- Clinique du dos — Bruges, France (Recruiting)
Study contacts
- Study coordinator: Jean-François Oudet
- Email: jf.oudet@ecten.eu
- Phone: 0683346567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.