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?

Adolescent Idiopathic Scoliosis Clinical Trial

— HISTORY  

Official title:

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927701
• Other study ID #: 8867
• Status: Recruiting
• Start date: July 6, 2023
• Est. completion date: July 6, 2026

Study information

• Verified date: September 2023
• Source: University Hospital, Strasbourg, France
• Contact: Yann Philippe CHARLES
• Phone: +33 3 88 11 58 11
• Email: YannPhilippe.CHARLES[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 6, 2026
• Est. primary completion date: July 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Other:
• Group comparaison
Questionnaires

Locations

Country	Name	City	State
France	Clinique du dos	Bruges
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term quality of life	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.	1 day
Secondary	The long-term quality of life	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)	1 day