NCT03309371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 14, 2018

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

October 9, 2017

Last Update Submit

March 12, 2018

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years

    Baseline, 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 13, 2017

Study Start

July 8, 2016

Primary Completion

August 31, 2016

Study Completion

December 31, 2017

Last Updated

March 14, 2018

Record last verified: 2017-10

Locations

FR(1)