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

Minimus Spine

Status and phase: Unknown; Phase 4

Conditions: Lumbar Disc Herniation

Treatments: Device: Triojection; Procedure: Surgical discectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02525120

1CP-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Triojection System for ozone injection

Experimental group

Description:

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.

Treatment:

Device: Triojection

Surgical discectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical discectomy