CClinicalTrials.gg
RecruitingNCT05108948COFTASDUpdated Feb 29, 2024

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

An observational study in Spinal Deformity, sponsored by Elsan. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Elsan · Observational

From the registry’s dates

  • Started Oct 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
866
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Deformity
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's planned enrollment of 866 is above the median of 153 across 446 observational studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

Elsan is the lead sponsor of 66 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient over 18 years-old with spinal deformity operated

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
866 participants (estimated)
Patient registry
No

Groups and cohorts

  • Spinal deformity operated patients

    Behavioral: Quality of life questionnaires · Procedure: Radiography

Interventions

  • BehavioralQuality 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

  • ProcedureRadiography

    Spinal radiography : full, face, profile

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05108948
Lead sponsor
Elsan
Collaborators
European Clinical Trial Experts Network
Responsible party
Sponsor
First posted
Nov 5, 2021
Start date
Oct 23, 2021
Primary completion
Oct 23, 2031 (estimated)
Completion
Oct 23, 2041 (estimated)
Last update
Feb 29, 2024

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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