NCT05108948 Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)
| NCT ID | NCT05108948 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elsan |
| Condition | Spinal Deformity |
| Study Type | OBSERVATIONAL |
| Enrollment | 866 participants |
| Start Date | 2021-10-23 |
| Primary Completion | 2031-10-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 866 participants in total. It began in 2021-10-23 with a primary completion date of 2031-10-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05108948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05108948 currently recruiting?
Yes, NCT05108948 is actively recruiting participants. Contact the research team at jf.oudet@ecten.eu for enrollment information.
Where is the NCT05108948 trial being conducted?
This trial is being conducted at Bruges, France.
Who is sponsoring the NCT05108948 clinical trial?
NCT05108948 is sponsored by Elsan. The trial plans to enroll 866 participants.