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
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