Actively Recruiting
Instrumented Posterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study
Led by Elsan · Updated on 2024-02-29
866
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
E
Elsan
Lead Sponsor
E
European Clinical Trial Experts Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on adolescent patients aged 12 to 20 years with idiopathic scoliosis who require surgical treatment but face a waiting period of six months or more. The study aims to identify factors that predict improvement in quality of life following surgery, which is important for understanding patient outcomes after scoliosis correction. Participants will not receive any experimental treatment but will complete several quality of life questionnaires such as the SRS-22r, SF-36, TAPS, and KIDSCREEN10. These behavioral assessments are used to gather information on health and well-being before and after surgery. Throughout the study, patients will be observed with a focus on changes in their quality of life one year after surgery, measured primarily by the SRS-22r score. Participants and their legal representatives will be informed about the study, and the research includes monitoring and evaluating patient responses to surgery over time.
CONDITIONS
Brief Title
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patient over 20 years old
- Non-surgical scoliosis
- Refusal to participate in the study by the child or parents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants complete quality of life questionnaires to assess outcomes after scoliosis surgery.
Periodic questionnaire assessments during the year
Trial Site Locations
Total: 1 location
1
Clinique du dos
Bruges, France, 33520
Actively Recruiting
Research Team
J
Jean-François Oudet
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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