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

August 4, 2021 updated by: Centre Hospitalier Universitaire de Nīmes

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: CHU Nimes

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with symptomatic spinal pathology requiring surgical or orthopedic treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life measured by the Oswestry Disability Index score
Time Frame: 24 months after surgical intervention
24 months after surgical intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life measured by the Oswestry Disability Index score
Time Frame: 6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention
6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2012

Primary Completion (Actual)

June 26, 2017

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2011/PK-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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