Intradiscal Discogel® in Resistant Sciatica

NCT02313350 | Withdrawn

• 1 other identifier: : P130913
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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

Keywords

Sciatica,; herniated disc,; chemonucleolysis.

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC) of the leg pain score on a 100-mm visual analogue scale

  The primary endpoint is the AUC of the leg pain score on a 100-mm visual-analogue scale, assessed by the patient in a self questionnaire at 4, 8, 16, 24 and 52 weeks, calculated by the trapezoidal method.The assessor will be blinded for the result of questionnaires

  4, 8, 16, 24 and 52 weeks

Secondary Outcomes (12)

• AUC of back pain score on a visual-analogue scale between 0 and 52 weeks

  4, 8, 16, 24 and 52 weeks

• AUC of global pain score on a visual-analogue scale between 0 and 52 weeks

  4, 8, 16, 24 and 52 weeks

• AUC of Quality of life (SF36) between 0 and 52 weeks

  4, 8, 16, 24 and 52 weeks

• Functional disability using the Roland disability questionnaire

  at 4, 8, 16, 24, 52 weeks

• Assessment of sciatica using the Modified Roland Morris disability scale

  at 4, 8, 16, 24, 52 weeks

Study Arms (2)

Chemonucleolysis with Discogel

EXPERIMENTAL

Discogel® is a class III medical device (CE0459 mark on 28/09/2007) constituted by a radiopaque jellified ethanol. Discogel® is provided in a kit containing a 2 ml solution for injection with two disposable 1ml syringes. Discogel® chemonucleolysis for herniated disc-related sciatica is performed under local anesthesia. A volume of 0.9 ml of Discogel® is finally slowly injected during 10 to 15 minutes

Device: Chemonucleolysis with Discogel

Open discectomy

ACTIVE COMPARATOR

surgery : 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

Procedure: open discectomy

Interventions

Chemonucleolysis with Discogel DEVICE

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 .

Chemonucleolysis with Discogel

open discectomy PROCEDURE

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.

Open discectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• 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

You may not qualify if:

• \- 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®

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Gelscom SAS: collaborator

Study Sites (1)

Department of Rheumatology, Lariboisière Hospital

Paris, 75010, France

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Sciatica

Interventions

Intervertebral Disc Chemolysis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics

Study Officials

• Johann Beaudreuil

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 10, 2014
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

FR (1)