About this trial
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years-old
Scoliosis with a Cobb angle ≥ 20 °
Vertical sagittal axis (SVA) ≥ 5 cm
Pelvic tilt ≥25 °,
Disqualifiers
Age under 18 years-old
Patient unlikely to comply with follow-up
Patient with long-term complete paraplegia
Patient unable to understand and answer questionnaires in due to language difficulties or cognitive impairment
Trial population
Patient over 18 years-old with spinal deformity operated
Trial design
Cohort
Prospective
Treatments tested in this trial
Quality of life questionnaires
BehavioralOswestry Disability Index Scoliosis Research Society-22R Short Form 36 Health Survey Questionnaire Tobacco, Alcohol, Prescription medication, and other Substance use Core Outcome Measures Index : back and neck
Radiography
Procedure/SurgerySpinal radiography : full, face, profile
Treatment groups
Trial outcomes
Primary outcomes
Factors associated with improved oswestry disability score
The factors associated with an improvement in the ODI score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in ODI score is defined as a decrease in score at 1 year of at least 10 points from baseline.
Sponsors and contacts
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Elsan
Lead sponsor
European Clinical Trial Experts Network
Collaborator