Status:
WITHDRAWN
Intradiscal Discogel® in Resistant Sciatica
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Gelscom SAS
Conditions:
Herniated Disc
Sciatica
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is the gold-standard and the only controlled treatment in case of failure of conservative treatment. Percutaneou...
Detailed Description
Since chymopapain was taken off the market in 2002, no percutaneous treatment has been proven to be a valuable alternative to surgical discectomy in herniated disk-related sciatica. Intradiscal inject...
Eligibility Criteria
Inclusion
- Age ≥18
- L5 or S1 sciatica due to a herniated disc demonstrated at a MRI performed at a maximum of 8 weeks prior to inclusion
- Leg pain intensity superior to 40mm on a visual-analogue scale despite pain medication (patient with pain level of less than 40 mm and under morphinic treatment, morphine should be first replaced by level 2 medication).
- Leg pain predominant over low back pain
- Duration of sciatica of the current symptomatic episode: from 6 weeks to 40 weeks
- Leg pain resistant to conservative treatment including at least two epidural steroid injections and at least one steroid injection under fluoroscopic guidance, during the current symptomatic episode
- With or without sensitive deficit
Exclusion
- \- Motricity index \< 3/5
- Cauda equinal syndrome
- Sequestered disc herniation visible at MRI
- Calcified/ossified disc herniation visible at MRI
- Intervertebral disc height narrowing \> 60%
- Previous back surgery or percutaneous disc treatment at the same intervertebral level
- Psychiatric status precluding patient evaluation
- Pregnancy Any known or documented allergy to one of the components of the Discogel®
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02313350
Start Date
September 1 2017
End Date
January 1 2018
Last Update
June 18 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Rheumatology, Lariboisière Hospital
Paris, France, 75010