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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Recruiting
CT.gov ID
NCT02886260
Collaborator
(none)
250
Enrollment
1
Location
121.1
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Aug 28, 2012
    Actual Primary Completion Date :
    Jun 26, 2017
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life measured by the Oswestry Disability Index score [24 months after surgical intervention]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Nimes Nimes France 30000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT02886260
    Other Study ID Numbers:
    • LOCAL/2011/PK-01
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Spinal Diseases
    Spinal Injuries

    Study Results

    No Results Posted as of Aug 5, 2021