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

Elsan

Status: Enrolling

Conditions: Spinal Deformity

Treatments: Behavioral: Quality of life questionnaires; Procedure: Radiography

Study type: Observational

Funder types: Other

Identifiers

NCT05108948

2021-A01753-38

Details and patient eligibility

About

The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.

Enrollment: 866 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

866 participants in 1 patient group

Spinal deformity operated patients

Treatment:

Behavioral: Quality of life questionnaires

Procedure: Radiography