An observational study in Idiopathic Scoliosis, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 10 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by University Hospital, Caen · Observational
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:
593 studies on the registry are indexed under Scoliosis; 138 are open to participants now.
This study's planned enrollment of 250 is above the median of 87 across 232 observational studies indexed under Scoliosis.
Browse Scoliosis studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.
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.
Time frame: At 1 years after surgery. Baseline questionnaire will be assessed just before the surgery
Radiological data: angulation parameters
Scoliosis 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)
Time frame: at the time of surgery and at one year fater surgery
Radiological data : type of scoliosis
Scoliosis radiological parameters before and after surgery (just after and at 1 year after surgery): type of scoliosis (lenkee classification)
Time frame: at the time of surgery and at one year fater surgery
Clinical data: age
Age at diagnosis and at surgery in months
Time frame: at the surgery
Clinical data: weight
weight (in kilograms)
Time frame: at the surgery
Clinical data: previous treatments
previous treatment for scoliosis (yes or no)
Time frame: at the surgery
Clinical data: family history
history of scoliosis in the family (yes or no)
Time frame: at the surgery
Surgery data
Type of instrumentation, level of instrumentation, surgical complications (neurological, infectious).
Time frame: during the firts year after the surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Caen