Clinical trial NCT05575596: Influence of Social Deprivation and Remoteness on Quality of Life in Adolescent's Surgical Scoliosis
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Scoliosis
Keywords: inequality
remoteness
socio economic
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Hôpital Necker-Enfants Malades
name: Hopital Universitaire Robert-Debre
name: Amiens University Hospital
name: University Hospital, Rouen
name: University Hospital, Lille
First posted: 2022-10-12
Enrollment: 250
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients operated in one of the participating pediatric surgery center (Paris centers : NECKER and Robert DEBRE, University Hospital of Caen, University Hospital of Amiens, University Hospital of ROUEN, University Hospital of LILLE). Only the patient operated by posterior vertebral arthrodesis will be included.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.
timeFrame: At 1 years after surgery. Baseline questionnaire will be assessed just before the surgery
Secondary outcomes:
measure: Radiological data: angulation parameters
timeFrame: at the time of surgery and at one year fater surgery
measure: Radiological data : type of scoliosis
timeFrame: at the time of surgery and at one year fater surgery
measure: Clinical data: age
timeFrame: at the surgery
measure: Clinical data: weight
timeFrame: at the surgery
measure: Clinical data: previous treatments
timeFrame: at the surgery
measure: Clinical data: family history
timeFrame: at the surgery
measure: Surgery data
timeFrame: during the firts year after the surgery
Other outcomes:
Locations:
city: Caen
country: France
facility: DOLET Nathan
state: Calvados
Study officials:
References: