Adolescent Idiopathic ScoliosisHISTORYNCT05927701
Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?
An observational study of Adolescent Idiopathic Scoliosis, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Group comparaison
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jul 2023to 6 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a Diagnosis of Adolescent Idiopathic Scoliosis aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
Who may be able to join
- Diagnosis of Adolescent Idiopathic Scoliosis
- Main baseline curve magnitude over 40º
- Aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
- More than 20 years of follow up
- Current contact information available
Who cannot join
- Non-idiopathic scoliosis
- Younger than 10 or older than 18 at the time of initial treatment
- Less than 20 years of follow up
- Patients unable to understand and answer the questionnaires because of language difficulties or because of cognitive impairments
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Clinique du dos
Bruges, 33 520
Ibrahim OBEID, ibrahim.obeid@gmail.com
+ 335 35 54 41 42
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67 200
Yann Philippe CHARLES, +33388115811, YannPhilippe.CHARLES@chru-strasbourg.fr
Yann Philippe CHARLES
About this study
Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity.
Posterior arthrodesis correction is a common practice surgery for the treatment of AIS after failure of medical treatment with a corset or functional rehabilitation. Surgery allows functional improvement and is indicated for curves greater than medically treated scoliosis.
Read more
The objective of this international study is to have a better understanding of the long-term outcomes (> 20 years of follow-up) after treatment (surgical and non-surgical) of AIS and to compare the long-term status of the patient with AIS to the general population of the same age, sex and comorbidities.
All of this information will help justify or modify the strategy, techniques and goals of early treatment in adolescence to achieve a better long-term outcome.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Group comparaison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group comparaisonOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Non-Surgical Group | Patients treated non-surgically during adolescence (<18 years of age) with a baseline Cobb >40º and minimum 20 years of follow-up. Receives: Other: Group comparaison | |
| Surgical Group | Patients treated surgically during adolescence (<18 years of age) with a baseline Cobb >40º, and minimum 20 years of follow-up Receives: Other: Group comparaison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term quality of life
Evaluate from the specific questionnaire for vertebral deformities: Scoliosis Research Society revisited(SRS-22r) (scale 0-5) with 5 sub-domains,higher scores representing greater patient quality of life.
Measured: 1 day
Secondary outcomes (1)
The long-term quality of life
Assess the long-term quality of life (> 20 years), health status, and social and demographic outcomes of adult patients who underwent treatment (surgical and non-surgical) for idiopathic scoliosis during adolescence by the questionnaire EQ-5D-5L (100 is the best health you can imagine.
0 is the worst health you can imagine)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start6 Jul 2023
- Primary completion6 Jul 2026 (estimated)
- Study completion6 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927701
- Sponsor's protocol ID
- 8867
- Acronym
- HISTORY
- Status last verified
- Sep 2023
- First submitted
- 22 Jun 2023
- Last updated
- 8 Sep 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?
- ClinicalTrials.gov ID
- NCT05927701
- Acronym / sponsor ID
- HISTORY / 8867
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 6 Jul 2026 (estimated)
- Study completion
- 6 Jul 2026 (estimated)
- First posted
- 3 Jul 2023 (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.
Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity.
Posterior arthrodesis correction is a common practice surgery for the treatment of AIS after failure of medical treatment with a corset or functional rehabilitation. Surgery allows functional improvement and is indicated for curves greater than medically treated scoliosis.
The objective of this international study is to have a better understanding of the long-term outcomes (> 20 years of follow-up) after treatment (surgical and non-surgical) of AIS and to compare the long-term status of the patient with AIS to the general population of the same age, sex and comorbidities.
All of this information will help justify or modify the strategy, techniques and goals of early treatment in adolescence to achieve a better long-term outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Surgical Group | – | Other: Group comparaisonPatients treated non-surgically during adolescence (<18 years of age) with a baseline Cobb >40º and minimum 20 years of follow-up. |
| Surgical Group | – | Other: Group comparaisonPatients treated surgically during adolescence (<18 years of age) with a baseline Cobb >40º, and minimum 20 years of follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Diagnosis of Adolescent Idiopathic Scoliosis aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
Key inclusion criteria (5 listed)
- Diagnosis of Adolescent Idiopathic Scoliosis
- Main baseline curve magnitude over 40º
- Aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
- More than 20 years of follow up
- Current contact information available
Key exclusion criteria (4 listed)
- Non-idiopathic scoliosis
- Younger than 10 or older than 18 at the time of initial treatment
- Less than 20 years of follow up
- Patients unable to understand and answer the questionnaires because of language difficulties or because of cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group comparaisonQuestionnaires | Other | Non-Surgical Group, Surgical Group |
Primary outcome
Long-term quality of life
Time frame: 1 day
Evaluate from the specific questionnaire for vertebral deformities: Scoliosis Research Society revisited(SRS-22r) (scale 0-5) with 5 sub-domains,higher scores representing greater patient quality of life.
1 secondary outcome
The long-term quality of life
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by University Hospital, Strasbourg, France at 2 sites 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 5 inclusion and 4 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Yann Philippe CHARLES (+33 3 88 11 58 11, YannPhilippe.CHARLES@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term quality of life (time frame: 1 day). 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 8 Sep 2023.