Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis (APOSIA)

February 28, 2024 updated by: Elsan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

866

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bruges, France, 33520
        • Recruiting
        • Clinique du dos
        • Contact:
          • Ibrahim Obeid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Idiopathic scoliosis in adolescents requiring surgery
Behavioral: Quality of life questionnaires
Different questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Collaborators

European Clinical Trial Experts Network
Asociación European Spine Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Estimated)

March 18, 2028

Study Completion (Estimated)

March 18, 2036

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A03069-30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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