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? (HISTORY)

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Other: Group comparaison

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Yann Philippe CHARLES; Phone Number: +33 3 88 11 58 11; Email: YannPhilippe.CHARLES@chru-strasbourg.fr

Study Locations

• France
  • Bruges, France, 33 520
    • Recruiting
    • Clinique du dos
    • Contact: Ibrahim OBEID; Email: ibrahim.obeid@gmail.com
    • Contact: Phone Number: + 335 35 54 41 42
    • Principal Investigator: Ibrahim OBEID
  • Strasbourg, France, 67 200
    • Recruiting
    • Hopitaux Universitaires de Strasbourg
    • Contact: Yann Philippe CHARLES; Phone Number: +33388115811; Email: YannPhilippe.CHARLES@chru-strasbourg.fr
    • Principal Investigator: Yann Philippe CHARLES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a Diagnosis of Adolescent Idiopathic Scoliosis aged 10 to 18 years at the time of treatment (surgical or nonsurgical)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-Surgical Group; Patients treated non-surgically during adolescence (<18 years of age) with a baseline Cobb >40º and minimum 20 years of follow-up.	Other: Group comparaison; Questionnaires
Surgical Group; Patients treated surgically during adolescence (<18 years of age) with a baseline Cobb >40º, and minimum 20 years of follow-up	Other: Group comparaison; Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): July 6, 2026
• Study Completion (Estimated): July 6, 2026

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 8867 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No