UnknownNot Applicable

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

France250 participantsStarted 2022-11-14

Plain-language 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.

Who can participate

Age range

10 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05575596

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11

View on ClinicalTrials.gov More Idiopathic Scoliosis trials