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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

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