Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?

Recruiting

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Other: Group comparaison

• Registration Number: NCT05927701
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity.

Posterior arthrodesis correction is a common practice surgery for the treatment of AIS after failure of medical treatment with a corset or functional rehabilitation. Surgery allows functional improvement and is indicated for curves greater than medically treated scoliosis.

The objective of this international study is to have a better understanding of the long-term outcomes (\> 20 years of follow-up) after treatment (surgical and non-surgical) of AIS and to compare the long-term status of the patient with AIS to the general population of the same age, sex and comorbidities.

All of this information will help justify or modify the strategy, techniques and goals of early treatment in adolescence to achieve a better long-term outcome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Study Start: 2023-07-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08
• Primary Completion: 2026-07-06
• Study Completion: 2026-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of Adolescent Idiopathic Scoliosis
• Main baseline curve magnitude over 40º
• Aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
• More than 20 years of follow up
• Current contact information available

Exclusion Criteria

• Non-idiopathic scoliosis
• Younger than 10 or older than 18 at the time of initial treatment
• Less than 20 years of follow up
• Patients unable to understand and answer the questionnaires because of language difficulties or because of cognitive impairments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Surgical Group	Group comparaison	Patients treated non-surgically during adolescence (\<18 years of age) with a baseline Cobb \>40º and minimum 20 years of follow-up.
Surgical Group	Group comparaison	Patients treated surgically during adolescence (\<18 years of age) with a baseline Cobb \>40º, and minimum 20 years of follow-up

Primary Outcome Measures

Name	Time	Method
Long-term quality of life	1 day	Evaluate from the specific questionnaire for vertebral deformities: Scoliosis Research Society revisited(SRS-22r) (scale 0-5) with 5 sub-domains,higher scores representing greater patient quality of life.

Secondary Outcome Measures

Name	Time	Method
The long-term quality of life	1 day	Assess the long-term quality of life (\> 20 years), health status, and social and demographic outcomes of adult patients who underwent treatment (surgical and non-surgical) for idiopathic scoliosis during adolescence by the questionnaire EQ-5D-5L (100 is the best health you can imagine.; 0 is the worst health you can imagine)

Trial Locations

Locations (2)

Clinique du dos; 🇫🇷 Bruges, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France