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

Recruiting

• Conditions: Spinal Deformity
• Interventions: Behavioral: Quality of life questionnaires; Procedure: Radiography

• Registration Number: NCT05108948
• Lead Sponsor: Elsan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-23
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2031-10-23
• Study Completion: 2041-10-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 866

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal deformity operated patients	Radiography	-
Spinal deformity operated patients	Quality of life questionnaires	-

Primary Outcome Measures

Name	Time	Method
Factors associated with improved oswestry disability score	15 years	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.

Trial Locations

Locations (1)

Clinique du dos; 🇫🇷 Bruges, France