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NCT Number: NCT05108948

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

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Key information

Conditions

Spinal Deformity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du dos

Bruges, 33520, France

Location status: Recruiting

Location contact

Ibrahim Obeid, Dr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Spinal radiography : full, face, profile

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François Oudet

CONTACT

[email protected]

0683346567

Marie-Hélène Barba

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Elsan

Other

Collaborators

  • European Clinical Trial Experts Network

Registry information

Official study title

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

Acronym: COFTASD

Important dates

Study start
2021
Primary completion
2031
Study completion
2041
First posted
Nov 5, 2021
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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