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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309371
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief 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.


Condition or disease
Hernia

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc
Actual Study Start Date : July 8, 2016
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years [ Time Frame: Baseline, 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
every patient with a DISCOGEL treatment between January 2014 and may of 2016
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309371


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03309371    
Other Study ID Numbers: DISCOGEL
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Radiculopathy
Hernia
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases