Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation

NCT ID: NCT02525120

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2020-05-31

Brief Summary

The primary objective of this study is to compare the early clinical outcomes following non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less than or equal to 6 months.

Detailed Description

The objective of this study is to compare clinical, economic and safety outcomes between Triojection and surgical discectomy. The study will include two follow-up phases: 1) an initial follow-up period during the first 6 months after treatment and (2) a long-term follow-up lasting an additional 18 months (2 years total).

The hypothesis is that over the first six months after treatment, Triojection® will be non-inferior to discectomy with respect to the improvement in leg pain. This will be demonstrated using a non-inferiority margin of 19.4 points on the difference between baseline leg pain score and the average leg pain score recorded at 1 week, 1, 3 and 6 months.

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Triojection System for ozone injection

Triojection is a system including a single-use sterile syringe cartridge and an accessory console. The console is interfaced to a supply of medical oxygen and uses this supply to fill the syringe with oxygen. Ozone is produced by applying a high voltage to electrodes physically located within the syringe. When a concentration of 35µg/ml is reached, the cartridge is removed from the console. The sterile syringe, containing the gas, is extracted from the protective housing and the gas is administered directly to the center of the herniated disc through a spinal needle.

Group Type: EXPERIMENTAL

Triojection

Intervention Type: DEVICE

Triojection is system intended to deliver a specific amount of ozone to a herniated disc.

Surgical discectomy

The surgical group will be receive a standard surgical discectomy to remove the herniated disc material.

Group Type: ACTIVE_COMPARATOR

Surgical discectomy

Intervention Type: PROCEDURE

Patients will receive surgery to remove the herniated disc material.

Interventions

Triojection

Triojection is system intended to deliver a specific amount of ozone to a herniated disc.

Intervention Type: DEVICE

Surgical discectomy

Patients will receive surgery to remove the herniated disc material.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patient is willing to provide informed consent.

2. Clinical and radiographic evidence of one, and only one, symptomatic protruding or extruded disc between L1 and S1.

3. The herniated disc should have a disc height of at least 50% that of the normal adjacent disc levels, as determined by the investigator.

4. The signal intensity of the herniated disc material should be equal or greater than the nucleus pulposus of the herniated disc.

5. The patient must have pain in a dermatomal distribution consistent with their radiographic findings

6. Leg pain greater than or equal to 5 on the NRS scale

7. Symptoms for at least 6 weeks

8. Willingness to complete all follow-up evaluations

9. Patient aged 18-65 years

10. BMI<40

Exclusion Criteria

1. Patients with a disc herniation extending past the facet joint

2. Presence of a non-contiguous disc fragment

3. Impairment of bladder/bowel function or motor impairment in the affected leg

4. An epidural steroid injection in the past 2 weeks

5. Previous discectomy, arthroplasty or fusion at any lumbar level

6. In patients with L5-S1 disc herniation, a congenital condition where the L5 vertebral body is either fused to the sacrum or the L5-S1 disc is not fully formed as a normal adult disc.

7. Symptomatic lumbar stenosis or listhesis

8. Symptomatic sacroiliac joint

9. Symptomatic foraminal stenosis due to severe degenerative disc disease

10. History of spinal tumor, fracture or infection

11. Females of childbearing age that are known to be pregnant or wishing to become pregnant during the study

12. Fibromyalgia

13. Active infection

14. Metastatic cancer within the past 5 years

15. Pending litigation against a health care provider

16. More than 3 months of continuous sick leave prior to enrollment.

17. Known drug or alcohol abuse

18. Diagnosed psychiatric disease or psychological distress caused by recent trauma like divorce, death of a member family or loss of a job

19. Patient known to be affected by favism (G6PD deficiency)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

genae international,ag

UNKNOWN

Sponsor Role: collaborator

Minimus Spine, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josip Buric, MD

Role: STUDY_DIRECTOR

Centro Chirurgico San Paolo, Pistoia, Italy

Locations

University General Hospital Attikon

Athens, Haidari, Greece

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Ospedale Regionale di Lugano- Civico e Italiano

Lugano, , Switzerland

Countries

Greece; Italy; Switzerland

Other Identifiers

1CP-1

Identifier Type: -

Identifier Source: org_study_id