Actively Recruiting
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)
Led by Elsan · Updated on 2024-02-29
866
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
E
Elsan
Lead Sponsor
E
European Clinical Trial Experts Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with spinal deformity who have undergone surgery to understand what factors predict an improvement in their quality of life one year after the operation. This observational study focuses on patients with specific spinal deformity characteristics, aiming to identify key elements linked to better recovery outcomes. The study involves assessing participants using quality of life questionnaires such as the Oswestry Disability Index, Scoliosis Research Society-22R, and Short Form 36 Health Survey Questionnaire. Participants also undergo spinal radiography in full, face, and profile views. These assessments help track physical and functional changes related to the spinal deformity and surgery. Participants will be followed for up to 15 years, with researchers measuring factors associated with improvement in the Oswestry Disability Score over time. Throughout the study, participants complete questionnaires and have imaging tests to monitor their progress. The study sponsor is Elsan, and the total participation duration may extend over many years to gather long-term data on recovery and quality of life.
CONDITIONS
Brief Title
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Diagnosis of adult spinal deformity with at least one of the following: scoliosis with a Cobb angle 2 degrees or more, vertical sagittal axis (SVA) 5 cm or more, pelvic tilt 25 degrees or more, or thoracic kyphosis with a Cobb angle 60 degrees or more
- Eligible for spinal deformity surgery
- Have agreed to participate in the study
- Affiliated with or beneficiary of a social security scheme
You will not qualify if you...
- Age under 18 years old
- Unlikely to comply with follow-up requirements
- Presence of long-term complete paraplegia
- Unable to understand or answer questionnaires due to language or cognitive difficulties
- Pregnant or breastfeeding women
- Adults under legal protection such as guardianship, curatorship, or deprived of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo spinal radiography and complete quality of life questionnaires before surgery.
1 visit (in-person)
Duration - Up to 15 years
Participants are observed over time with follow-up questionnaires and radiography to assess quality of life and spinal status.
Periodic visits for assessments
Trial Site Locations
Total: 1 location
1
Clinique du dos
Bruges, France, 33520
Actively Recruiting
Research Team
J
Jean-François Oudet
M
Marie-Hélène Barba
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here