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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05108948

Acronym

COFTASD

Enrollment

866

Registered

2021-11-05

Start date

2021-10-23

Completion date

2041-10-23

Last updated

2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Deformity

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.

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Contacts

Primary ContactJean-François Oudet

jf.oudet@ecten.eu0683346567

Backup ContactMarie-Hélène Barba

mh.barba@ecten.eu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026