Scoliosis; AdolescenceAPOSIANCT05145725
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis
An observational study of Scoliosis; Adolescence and Arthrodesis, run by Elsan at 1 site in France.
Trial summary
The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months. The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Scoliosis; Adolescence, Arthrodesis
- What is being tested?
- Quality of life questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 866 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2021to 18 Mar 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents between 12 and 20 years old, suffering from scoliosis. Surgery has been proposed to them. 150 patients are French over the 866 patients.
Who may be able to join
- Patient between 12 and 20 years old
- Scoliosis in adolescents for whom surgery has been proposed based on radiological criteria (Cobb angle> 25 ° for thoracolumbar and lumbar scoliosis,> 35 ° for thoracic scoliosis and> 40 ° for double major scoliosis)
- Patient affiliated or beneficiary of a social security scheme or attached to a beneficiary of a social security scheme
- Patient and legal representative having been informed and not opposing this research
Who cannot join
- Patient over 20 years old
- Non-surgical scoliosis
- Refusal to participate in the study by the child or parents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique du dos
Bruges, 33520
Ibrahim Obeid
About this study
Official title: Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study
The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months.
The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.
- Conditions
- Scoliosis; Adolescence, Arthrodesis
- Being tested
- Quality of life questionnaires
- Medical subject headings
- Scoliosis, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesBehavioural
Different questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic scoliosis in adolescents requiring surgery | Not described Receives: Behavioral: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with an improvement in the SRS-22r score
Factors associated with an improvement in the SRS-22r score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in SRS-22r score is defined as an increase in the total score at 1 year of at least 10% from value.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start18 Mar 2021
- Primary completion18 Mar 2028 (estimated)
- Study completion18 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- 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
- 866 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Asociación European Spine Study Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145725
- Sponsor's protocol ID
- 2020-A03069-30
- Acronym
- APOSIA
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study
- ClinicalTrials.gov ID
- NCT05145725
- Acronym / sponsor ID
- APOSIA / 2020-A03069-30
- Conditions
- Scoliosis; Adolescence, Arthrodesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 866 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Asociación European Spine Study Group
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 18 Mar 2028 (estimated)
- Study completion
- 18 Mar 2036 (estimated)
- First posted
- 6 Dec 2021 (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 study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months.
The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic scoliosis in adolescents requiring surgery | – | Behavioral: Quality of life questionnaires |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents between 12 and 20 years old, suffering from scoliosis. Surgery has been proposed to them. 150 patients are French over the 866 patients.
Key inclusion criteria (4 listed)
- Patient between 12 and 20 years old
- Scoliosis in adolescents for whom surgery has been proposed based on radiological criteria (Cobb angle> 25 ° for thoracolumbar and lumbar scoliosis,> 35 ° for thoracic scoliosis and> 40 ° for double major scoliosis)
- Patient affiliated or beneficiary of a social security scheme or attached to a beneficiary of a social security scheme
- Patient and legal representative having been informed and not opposing this research
Key exclusion criteria (3 listed)
- Patient over 20 years old
- Non-surgical scoliosis
- Refusal to participate in the study by the child or parents
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 |
|---|---|---|
| Quality of life questionnairesDifferent questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10 | Behavioural | Idiopathic scoliosis in adolescents requiring surgery |
Primary outcome
Factors associated with an improvement in the SRS-22r score
Time frame: 1 year
Factors associated with an improvement in the SRS-22r score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in SRS-22r score is defined as an increase in the total score at 1 year of at least 10% from value.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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.
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 Scoliosis; Adolescence and Arthrodesis, run by Elsan 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 4 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: looking for participants now, as of the sponsor's last update on 29 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with an improvement in the SRS-22r score (time frame: 1 year). 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 29 Feb 2024.