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Influence of Social Deprivation and Remoteness on Quality of Life in Adolescent's Surgical Scoliosis

Impact Des inégalités Socio-économiques et Territoriales Sur la qualité de Vie pré et Post opératoire Des Scolioses Idiopathiques Prisent en Charge en Milieu pédiatrique

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05575596
Enrollment
250
Registered
2022-10-12
Start date
2022-11-14
Completion date
2024-11-30
Last updated
2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Scoliosis

Keywords

inequality, remoteness, socio economic

Brief summary

The incidence of idiopathic scoliosis is 3% or approximatively 300,000 new cases per year in France. It is estimated that between 0.1 and 0.3% of patients will eventually require surgical management, between 500 and 1000 scoliosis are operated per year in France. To our knowledge, the impact of socio-economic and territorial inequalities on the quality of life before and after surgery of idiopathic scoliosis has not been studied previously. Main objective: -Assess the impact of socio-economic and territorial inequalities on the pre- and post-operative quality of life at 1 year after surgical idiopathic scoliosis management, in a French pediatric surgery multicenter cohort. Secondary objective: * Assess the impact of socio-economic and territorial inequalities on the quality of life pre and postoperative at 3 months after surgery on a French multicenter cohort. * To assess the impact of severity and type of scoliosis on pre- and post-operative quality of life at 3 months and 1 year after surgery on a French multicenter cohort.

Interventions

None listed

Sponsors

Hôpital Necker-Enfants Malades
CollaboratorOTHER
Hopital Universitaire Robert-Debre
CollaboratorOTHER
Amiens University Hospital
CollaboratorOTHER
University Hospital, Rouen
CollaboratorOTHER
University Hospital, Lille
CollaboratorOTHER
University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 25 Years

Inclusion criteria

* Operated by posterior vertebral arthrodesis * Opereted in pediatric surgery center * Idiopathic scoliosis treated by surgery

Exclusion criteria

* Refusal to participate * People unable to read or speak French (the questionnaire being in French) * Non-idiopathic scoliosis

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.At 1 years after surgery. Baseline questionnaire will be assessed just before the surgeryWe will use the SRS-22 questionnaire, a specific questionnaire validated in French to assess the quality of life of patients with scoliosis. The questionnaire coverts different part of socio-economic levels including the salary, the educational level, the type of social security coverage, the parents' family situation (single parent, two-parent, blended couple) and the number of people and pieces in the habitation. The remoteness will be evaluated by the distance between the medical referent center and the habitation.

Secondary

MeasureTime frameDescription
Radiological data : type of scoliosisat the time of surgery and at one year fater surgeryScoliosis radiological parameters before and after surgery (just after and at 1 year after surgery): type of scoliosis (lenkee classification)
Clinical data: ageat the surgeryAge at diagnosis and at surgery in months
Clinical data: weightat the surgeryweight (in kilograms)
Radiological data: angulation parametersat the time of surgery and at one year fater surgeryScoliosis radiological parameters before and after surgery (just after and at 1 year after surgery) cobb, kyphosis, lordosis, pelvic incidence (unit of measure: angulation in degrees)
Clinical data: family historyat the surgeryhistory of scoliosis in the family (yes or no)
Surgery dataduring the firts year after the surgeryType of instrumentation, level of instrumentation, surgical complications (neurological, infectious).
Clinical data: previous treatmentsat the surgeryprevious treatment for scoliosis (yes or no)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026