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Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05145725
Acronym
APOSIA
Enrollment
866
Registered
2021-12-06
Start date
2021-03-18
Completion date
2036-03-18
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrodesis, Scoliosis; Adolescence

Brief 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.

Interventions

BEHAVIORALQuality of life questionnaires

Different questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10

Sponsors

European Clinical Trial Experts Network
CollaboratorOTHER
Asociación European Spine Study Group
CollaboratorUNKNOWN
Elsan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patient over 20 years old * Non-surgical scoliosis * Refusal to participate in the study by the child or parents

Design outcomes

Primary

MeasureTime frameDescription
Factors associated with an improvement in the SRS-22r score1 yearFactors 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.

Countries

France

Contacts

Primary ContactJean-François Oudet
jf.oudet@ecten.eu0683346567

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026