Factors affecting quality of life improvement in adults treated for spinal deformity
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)
This study is trying to find out what factors help adults with spinal deformities feel better after surgery by looking at their quality of life and health information.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 866 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT05108948 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the predictive factors that influence the improvement of quality of life in adult patients who have undergone surgery for spinal deformity. Participants will complete quality of life questionnaires and undergo radiographic assessments to evaluate their condition. The study focuses on adults diagnosed with specific spinal deformities, including scoliosis and kyphosis, who are eligible for surgical intervention. By analyzing the collected data, researchers hope to better understand the factors that contribute to successful outcomes in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with specific spinal deformities and eligible for surgery.
Not a fit: Patients under 18 years old, those with long-term complete paraplegia, or individuals unable to comply with follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and enhanced quality of life for patients with spinal deformities.
How similar studies have performed: While similar studies have explored quality of life in spinal deformity patients, this specific approach to identifying predictive factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bruges
- Clinique du dos — Bruges, France (Recruiting)
Study contacts
- Study coordinator: Jean-François Oudet
- Email: jf.oudet@ecten.eu
- Phone: 0683346567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.