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Intradiscal Discogel® in Resistant Sciatica

NCT02313350 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-06-18

No results posted yet for this study

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.

Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery.

In addition, Discogel® chemonucleolysis appears as a relatively innocuous technique which may avoid 2% complications after disc surgery and 5% repeated surgery (according to recent trials).

This will be the first randomized trial comparing Discogel® chemonucleolysis versus surgery in patients with sciatica due to lumbar disc herniation and unresponsive to conservative medical treatments (including epidural steroid injections) Our expectation is that Discogel® chemonucleolysis will avoid surgery in 80% of the patients.

Conditions

  • Herniated Disc
  • Sciatica
  • Persistent Pain, Leg

Interventions

DEVICE

Chemonucleolysis with Discogel

Discogel® is provided in a kit containing a 2 ml solution for injection with two disposable 1ml syringes, each for single use which is stored at room temperature. Discogel® chemonucleolysis for herniated disc-related sciatica is performed under local anesthesia .

PROCEDURE

open discectomy

The comparator is open surgical discectomy. The procedure will be performed under general anesthesia. It will consist in removing the disc herniation after exposition and examination of the nerve root.

Sponsors & Collaborators

  • Gelscom SAS

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Johann Beaudreuil · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313350 on ClinicalTrials.gov