Recruiting NCT05108948
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality of life questionnaires, Radiography.
- Who it may be relevant to
- Registry conditions: Spinal Deformity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)
Overview
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.
Interventions
- Behavioral Quality of life questionnaires
Oswestry 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 - Procedure Radiography
Spinal radiography : full, face, profile
Primary outcome measures
- Factors associated with improved oswestry disability score [Time frame: 15 years]
Eligibility criteria
Inclusion criteria
- Age over 18 years-old
- Diagnosis of Adult Spinal Deformity with any of the deformity characteristics following:
- Scoliosis with a Cobb angle ≥ 20 °
- Vertical sagittal axis (SVA) ≥ 5 cm
- Pelvic tilt ≥25 °,
- Thoracic kyphosis with a Cobb angle ≥ 60 °
- Eligible for surgery
- Having given their participation agreement
- Affiliate or beneficiary of a social security scheme
Exclusion criteria
- 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
- Pregnant or breastfeeding woman
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Clinique du dos — Bruges
Identifiers
NCT: NCT05108948 · 2021-A01753-38