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?

NCT ID: NCT05927701

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-06

Study Completion Date

2026-07-06

Brief Summary

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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

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Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Group comparaison

Intervention Type OTHER

Questionnaires

Surgical Group

Patients treated surgically during adolescence (\<18 years of age) with a baseline Cobb \>40º, and minimum 20 years of follow-up

Group comparaison

Intervention Type OTHER

Questionnaires

Interventions

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Group comparaison

Questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique du dos

Bruges, , France

Site Status RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yann Philippe CHARLES

Role: CONTACT

+33 3 88 11 58 11

Facility Contacts

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Ibrahim OBEID

Role: primary

Role: backup

+ 335 35 54 41 42

Yann Philippe CHARLES

Role: primary

+33388115811

Other Identifiers

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8867

Identifier Type: -

Identifier Source: org_study_id

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