Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)
COFTASD
1 other identifier
observational
866
1 country
1
Brief Summary
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2021
CompletedFirst Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 23, 2041
February 29, 2024
February 1, 2024
10 years
October 26, 2021
February 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
15 years
Study Arms (1)
Spinal deformity operated patients
Interventions
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
Eligibility Criteria
Patient over 18 years-old with spinal deformity operated
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elsanlead
- European Clinical Trial Experts Networkcollaborator
Study Sites (1)
Clinique du dos
Bruges, 33520, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 5, 2021
Study Start
October 23, 2021
Primary Completion (Estimated)
October 23, 2031
Study Completion (Estimated)
October 23, 2041
Last Updated
February 29, 2024
Record last verified: 2024-02