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?

NCT05927701 | Recruiting

• 1 other identifier: 8867
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The long-term quality of life

  1 day

Study Arms (2)

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

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

Interventions

Group comparaison OTHER

Questionnaires

Non-Surgical Group; Surgical Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (2)

Clinique du dos

Bruges, 33 520, France

RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67 200, France

RECRUITING

Central Study Contacts

Yann Philippe CHARLES

CONTACT

+33 3 88 11 58 11; YannPhilippe.CHARLES@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: July 6, 2023
• Primary Completion: July 6, 2026
• Study Completion: July 6, 2026
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

FR (2)