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

NCT ID: NCT05108948

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

866 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-23

Study Completion Date

2041-10-23

Brief Summary

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

Detailed Description

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Conditions

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Spinal Deformity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal deformity operated patients

Quality of life questionnaires

Intervention Type 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

Intervention Type PROCEDURE

Spinal radiography : full, face, profile

Interventions

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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

Intervention Type BEHAVIORAL

Radiography

Spinal radiography : full, face, profile

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Elsan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique du dos

Bruges, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

0683346567

Marie-Hélène Barba

Role: CONTACT

Facility Contacts

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Ibrahim Obeid, Dr

Role: primary

Other Identifiers

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2021-A01753-38

Identifier Type: -

Identifier Source: org_study_id

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