Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

Recruiting

• Conditions: Scoliosis; Adolescence; Arthrodesis
• Interventions: Behavioral: Quality of life questionnaires

• Registration Number: NCT05145725
• Lead Sponsor: Elsan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-18
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2028-03-18
• Study Completion: 2036-03-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 866

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idiopathic scoliosis in adolescents requiring surgery	Quality of life questionnaires	-

Primary Outcome Measures

Name	Time	Method
Factors associated with an improvement in the SRS-22r score	1 year	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.

Trial Locations

Locations (1)

Clinique du dos; 🇫🇷 Bruges, France