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

Completed

• Conditions: Hernia

• Registration Number: NCT03309371
• Lead Sponsor: Fondation Hôpital 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-08
• Primary Completion: 2016-08-31
• Status Verified: 2017-10
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-13
• Study Completion: 2017-12-31
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years	Baseline, 2 years

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, Ile-de-France, France