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

Recruiting

• Conditions: Idiopathic Scoliosis

• Registration Number: NCT05575596
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-12
• Study Start: 2022-11-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-18
• Last Update Posted: 2023-03-21
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 Outcome Measures

Name	Time	Method
Radiological data: angulation parameters	at the time of surgery and at one year fater surgery	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)
Clinical data: age	at the surgery	Age at diagnosis and at surgery in months
Clinical data: previous treatments	at the surgery	previous treatment for scoliosis (yes or no)
Radiological data : type of scoliosis	at the time of surgery and at one year fater surgery	Scoliosis radiological parameters before and after surgery (just after and at 1 year after surgery): type of scoliosis (lenkee classification)
Clinical data: weight	at the surgery	weight (in kilograms)
Clinical data: family history	at the surgery	history of scoliosis in the family (yes or no)
Surgery data	during the firts year after the surgery	Type of instrumentation, level of instrumentation, surgical complications (neurological, infectious).

Trial Locations

Locations (1)

DOLET Nathan; 🇫🇷 Caen, Calvados, France