Idiopathic ScoliosisNCT05575596
Influence of Social Deprivation and Remoteness on Quality of Life in Adolescent's Surgical Scoliosis
An observational study of Idiopathic Scoliosis, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Idiopathic Scoliosis
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2022to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Child, Adult
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.
Who may be able to join
- Operated by posterior vertebral arthrodesis
- Opereted in pediatric surgery center
- Idiopathic scoliosis treated by surgery
Who cannot join
- Refusal to participate
- People unable to read or speak French (the questionnaire being in French)
- Non-idiopathic scoliosis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
DOLET Nathan
Caen, Calvados, 14000
nathan dolet, MD, +33664118755, nathan_dolet@hotmail.com
Benoit KIPPER, MD, +33231064478, kipper-b@chu-caen.fr
About this study
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
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:
Read more
-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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 years after surgery. Baseline questionnaire will be assessed just before the surgery
Secondary outcomes (7)
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)
Measured: at the time of surgery and at one year fater surgery
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)
Measured: at the time of surgery and at one year fater surgery
Clinical data: age
Age at diagnosis and at surgery in months
Measured: at the surgery
Clinical data: weight
weight (in kilograms)
Measured: at the surgery
Clinical data: previous treatments
previous treatment for scoliosis (yes or no)
Measured: at the surgery
Clinical data: family history
history of scoliosis in the family (yes or no)
Measured: at the surgery
Surgery data
Type of instrumentation, level of instrumentation, surgical complications (neurological, infectious).
Measured: during the firts year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start14 Nov 2022
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades, Hopital Universitaire Robert-Debre, Amiens University Hospital, University Hospital, Rouen, University Hospital, Lille
- Responsible party
- Principal investigator, Nathan DOLET, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575596
- Sponsor's protocol ID
- ISASE001
- Status last verified
- Mar 2023
- First submitted
- 3 Oct 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05575596
- Acronym / sponsor ID
- ISASE001
- Conditions
- Idiopathic Scoliosis
- Keywords
- inequality, remoteness, socio economic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades, Hopital Universitaire Robert-Debre, Amiens University Hospital, University Hospital, Rouen, University Hospital, Lille
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Operated by posterior vertebral arthrodesis
- Opereted in pediatric surgery center
- Idiopathic scoliosis treated by surgery
Key exclusion criteria (3 listed)
- Refusal to participate
- People unable to read or speak French (the questionnaire being in French)
- Non-idiopathic scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Radiological data: angulation parameters
Time frame: 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
Clinical data: age
Time frame: at the surgery
Clinical data: weight
Time frame: at the surgery
Clinical data: previous treatments
Time frame: at the surgery
Clinical data: family history
Time frame: at the surgery
Surgery data
Time frame: during the firts year after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.