Scoliosis; Adolescence Clinical Trial
— APOSIAOfficial title:
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study
| Verified date | February 2024 |
| Source | Elsan |
| Contact | Jean-François Oudet |
| Phone | 0683346567 |
| jf.oudet[@]ecten.eu | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique du dos | Bruges |
| Lead Sponsor | Collaborator |
|---|---|
| Elsan | Asociación European Spine Study Group, European Clinical Trial Experts Network |
France,
| 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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