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NCT Number: NCT05145725

Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

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.

Recruiting

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Key information

Conditions

Scoliosis; Adolescence Ankylosis Arthrodesis Bone Diseases Joint Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du dos

Bruges, 33520, France

Location status: Recruiting

Location contact

Ibrahim Obeid

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life questionnaires

Behavioral

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François Oudet

CONTACT

[email protected]

0683346567

Sponsors and collaborators

Lead sponsor

Elsan

Other

Collaborators

  • Asociación European Spine Study Group
  • European Clinical Trial Experts Network

Registry information

Official study title

Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study

Acronym: APOSIA

Important dates

Study start
2021
Primary completion
2028
Study completion
2036
First posted
Dec 6, 2021
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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