Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-20
SponsorElsan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient over 20 years old
Non-surgical scoliosis
Refusal to participate in the study by the child or parents
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Quality of life questionnaires
BehavioralDifferent questionnaires to fill : SRS-22r, SF-36 score, TAPS, KIDSCREEN10
Treatment groups
866 Participants
are divided into 1 treatment groupGroup A: Idiopathic scoliosis in adolescents requiring surgery1 intervention
Trial outcomes
Primary outcomes
1
Factors associated with an improvement in the SRS-22r score
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Elsan
Lead sponsor
European Clinical Trial Experts Network
Collaborator
Asociación European Spine Study Group
Collaborator
Source ClinicalTrials.gov