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NCT05108948 Clinical Trial

Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)

Spinal Deformity Clinical Trial

— COFTASD  

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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05108948
Other study ID # 2021-A01753-38
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2021
Est. completion date October 23, 2041

Study information
Verified date February 2024
Source Elsan
Contact Jean-François Oudet
Phone 0683346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 866
Est. completion date October 23, 2041
Est. primary completion date October 23, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Clinique du dos Bruges

Sponsors (2)
Lead Sponsor Collaborator
Elsan European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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