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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorElsan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years-old

Scoliosis with a Cobb angle ≥ 20 °

Vertical sagittal axis (SVA) ≥ 5 cm

Pelvic tilt ≥25 °,

Disqualifiers

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

Trial population

Patient over 18 years-old with spinal deformity operated

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quality of life questionnaires

    Behavioral

    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

  • Radiography

    Procedure/Surgery

    Spinal radiography : full, face, profile

Treatment groups

866 Participants
are divided into 1 treatment group
Group A: Spinal deformity operated patients2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
15 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elsan

Lead sponsor

European Clinical Trial Experts Network

Collaborator