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

Idiopathic Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575596
• Other study ID #: ISASE001
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: November 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Locations

Country	Name	City	State
France	DOLET Nathan	Caen	Calvados

Sponsors (6)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 1 years after surgery. Baseline questionnaire will be assessed just before the surgery
Secondary	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)	at the time of surgery and at one year fater surgery
Secondary	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)	at the time of surgery and at one year fater surgery
Secondary	Clinical data: age	Age at diagnosis and at surgery in months	at the surgery
Secondary	Clinical data: weight	weight (in kilograms)	at the surgery
Secondary	Clinical data: previous treatments	previous treatment for scoliosis (yes or no)	at the surgery
Secondary	Clinical data: family history	history of scoliosis in the family (yes or no)	at the surgery
Secondary	Surgery data	Type of instrumentation, level of instrumentation, surgical complications (neurological, infectious).	during the firts year after the surgery