HISTORY: 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?

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05927701
Collaborator
(none)
100
2
36
50
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group comparaison

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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?
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique du dos Bruges France 33 520
2 Hôpitaux Universitaires de Strasbourg Strasbourg France 67 200

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT05927701
Other Study ID Numbers:
  • 8867
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023