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

March 18, 2023 updated by: Nathan DOLET, University Hospital, Caen

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.
Time Frame: 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.
At 1 years after surgery. Baseline questionnaire will be assessed just before the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological data: angulation parameters
Time Frame: 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)
at the time of surgery and at one year fater surgery
Radiological data : type of scoliosis
Time Frame: 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)
at the time of surgery and at one year fater surgery
Clinical data: age
Time Frame: at the surgery
Age at diagnosis and at surgery in months
at the surgery
Clinical data: weight
Time Frame: at the surgery
weight (in kilograms)
at the surgery
Clinical data: previous treatments
Time Frame: at the surgery
previous treatment for scoliosis (yes or no)
at the surgery
Clinical data: family history
Time Frame: at the surgery
history of scoliosis in the family (yes or no)
at the surgery
Surgery data
Time Frame: during the firts year after the surgery
Type of instrumentation, level of instrumentation, surgical complications (neurological, infectious).
during the firts year after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Hopital Universitaire Robert-Debre
University Hospital, Rouen
University Hospital, Lille
Amiens University Hospital
Hôpital Necker-Enfants Malades

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 9, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 18, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISASE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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