DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc

March 12, 2018 updated by: Groupe Hospitalier Paris Saint Joseph

Lumbar disc herniation is the most important and frequent affection in rheumatology. The first treatment is based on an non-steroidal anti-inflammatory drugs.Physiotherapy also is used.But when there is no efficient result, it's usual to propose to the patient corticoid injection, percutaneous intervention or arthrodesis.

Recently DISCOGEL® is a medical device used for lumbar disc herniation. However there is no studies evaluating the benefit and the efficiency of this technic. Since a few years, the rheumatology service of GHPSJ practise this technic using DISCOGEL® with patient resistant to the medical treatment . So the aim is to evaluate the benefit of DISCOGEL® retrospectively.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

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

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

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

Probability Sample

Study Population

every patient with a DISCOGEL treatment between January 2014 and may of 2016

Description

Inclusion Criteria:

  • age> 18
  • lumbar radiculalgy
  • lumbar disc herniation described by MRI
  • more than 6 weeks
  • prescription of DISCOGEL

Exclusion Criteria:

  • medical history of surgery at the same stage
  • patient under Clopidogrel or prasugrel

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years
Time Frame: Baseline, 2 years
Baseline, 2 years

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

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)

July 8, 2016

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISCOGEL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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