Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

NCT ID: NCT05145725

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

866 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-18

Study Completion Date

2036-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scoliosis; Adolescence Arthrodesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Idiopathic scoliosis in adolescents requiring surgery

Quality of life questionnaires

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality of life questionnaires

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Asociación European Spine Study Group

UNKNOWN

Sponsor Role collaborator

Elsan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique du dos

Bruges, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean-François Oudet

Role: CONTACT

0683346567

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ibrahim Obeid

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A03069-30

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Trial on Three Treatments for Scoliosis
NCT01761305 ACTIVE_NOT_RECRUITING NA