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

NCT05575596 | Unknown

• 1 other identifier: ISASE001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Scoliosis

Keywords

inequality; remoteness; socio economic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Radiological data: angulation parameters

  at the time of surgery and at one year fater surgery

• Radiological data : type of scoliosis

  at the time of surgery and at one year fater surgery

• Clinical data: age

  at the surgery

• Clinical data: weight

  at the surgery

• Clinical data: previous treatments

  at the surgery

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Operated by posterior vertebral arthrodesis
• Opereted in pediatric surgery center
• Idiopathic scoliosis treated by surgery

You may not qualify if:

• Refusal to participate
• People unable to read or speak French (the questionnaire being in French)
• Non-idiopathic scoliosis

Sponsors & Collaborators

• University Hospital, Caen: lead
• Hôpital Necker-Enfants Malades: collaborator
• Hopital Universitaire Robert-Debre: collaborator
• Amiens University Hospital: collaborator
• University Hospital, Rouen: collaborator
• University Hospital, Lille: collaborator

Study Sites (1)

DOLET Nathan

Caen, Calvados, 14000, France

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 12, 2022
• Study Start: November 14, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

FR (1)