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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Caen
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.
Time Frame: At 1 years after surgery. Baseline questionnaire will be assessed just before the surgery
We 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 Outcomes
- Clinical data: age(at the surgery)
- Radiological data: angulation parameters(at the time of surgery and at one year fater surgery)
- Clinical data: previous treatments(at the surgery)
- Radiological data : type of scoliosis(at the time of surgery and at one year fater surgery)
- Clinical data: weight(at the surgery)
- Clinical data: family history(at the surgery)
- Surgery data(during the firts year after the surgery)
Investigators
Nathan DOLET
MD
University Hospital, Caen