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

February 28, 2024 updated by: Elsan

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

866

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient over 18 years-old with spinal deformity operated

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spinal deformity operated patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors associated with improved oswestry disability score
Time Frame: 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.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Collaborators

European Clinical Trial Experts Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2021

Primary Completion (Estimated)

October 23, 2031

Study Completion (Estimated)

October 23, 2041

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01753-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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