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NCT03309371 Clinical Trial

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

Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03309371
Other study ID # DISCOGEL
Secondary ID
Status Completed
Phase N/A
First received October 9, 2017
Last updated March 12, 2018
Start date July 8, 2016
Est. completion date December 31, 2017

Study information
Verified date October 2017
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date December 31, 2017
Est. primary completion date August 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years Baseline, 2 years
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