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NCT02886260 Clinical Trial

Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine

Quality of Life Clinical Trial

— KEOPS  

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02886260
Other study ID # LOCAL/2011/PK-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 28, 2012
Est. completion date October 2022

Study information
Verified date August 2021
Source Centre Hospitalier Universitaire de Nimes
Contact CHU Nimes
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to: 1. describe the monitoring of patients treated for spinal disorders. 2. create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data. 3. obtain a cohort of patients in the comprehensive range of spinal pathologies. 4. standardize data collection in this cohort with similar national projects.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date October 2022
Est. primary completion date June 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The patient must be given free and informed consent and signed the consent - The patient must be affiliated or beneficiary of a health insurance plan - The patient is available for a 24-month follow-up - The patient is at least 18 years old - The patient has a symptomatic spinal pathology requiring surgical or orthopedic treatment Exclusion Criteria: - The patient is under judicial protection, guardianship or curatorship - The patient refuses to sign the consent - It is not possible to give informed information to the patient - The patient does not fluently read French. - the patient is not available for a 24-month follow-ip

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Nimes Nimes

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life measured by the Oswestry Disability Index score 24 months after surgical intervention
Secondary Quality of life measured by the Oswestry Disability Index score 6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention
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