APOSIA: Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis

Sponsor

Elsan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05145725

Collaborator

European Clinical Trial Experts Network (Other), Asociación European Spine Study Group (Other)

866

Enrollment

Location

180

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis; Adolescence Arthrodesis	Behavioral: Quality of life questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

866 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study

Actual Study Start Date :

Mar 18, 2021

Anticipated Primary Completion Date :

Mar 18, 2028

Anticipated Study Completion Date :

Mar 18, 2036

Arms and Interventions

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

Arm

Intervention/Treatment

Idiopathic scoliosis in adolescents requiring surgery

Behavioral: Quality of life questionnaires

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

Outcome Measures

Primary Outcome Measures

Factors associated with an improvement in the SRS-22r score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique du dos	Bruges		France	33520

Sponsors and Collaborators

Elsan
European Clinical Trial Experts Network
Asociación European Spine Study Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elsan

ClinicalTrials.gov Identifier:

NCT05145725

Other Study ID Numbers:

2020-A03069-30

First Posted:

Dec 6, 2021

Last Update Posted:

Dec 6, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Study Results

No Results Posted as of Dec 6, 2021