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

Phase 4

• Conditions: Lumbar Disc Herniation
• Interventions: Device: Triojection; Procedure: Surgical discectomy

• Registration Number: NCT02525120
• Lead Sponsor: Minimus Spine, Inc

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-17
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06
• Primary Completion: 2018-12
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triojection System for ozone injection	Triojection	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.
Surgical discectomy	Surgical discectomy	The surgical group will be receive a standard surgical discectomy to remove the herniated disc material.

Primary Outcome Measures

Name	Time	Method
Leg pain NRS	Baseline, 1 week, 1, 3 and 6 months.	The primary outcome measure will be the amount of improvement in leg pain after treatment. This will be determined by taking the difference between the baseline score and the average of the post-treatment scores at 1 week, 1, 3 and 6 months.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction via a survey	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.	Brief questionnaire asking patients to rate their level of satisfaction.
Cost Diary	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.	Survey asking patients to detail their medical expenses, work status, time off work etc.
Leg pain NRS	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.	Leg pain Numerical Rating Scale (NRS) at each visit.
Review of MRI images	Baseline and 6 and 24 months after treatment.	Blinded, independent MRI review to determine reduction in disc herniation following treatment and evaluate index and adjacent levels for evidence of degeneration.
Back pain NRS	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.	Back pain Numerical Rating Scale (NRS) at each visit
Functional Score measured by RMDI.	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.	Roland Morris Disability Index. A 24 question survey asking the subject if they have difficulty with various activities of daily living.
Quality of Life measured by EQ-5D	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.	EQ-5D is a validated survey asking the subject 5 multiple choice questions and to indicate their general health status on a scale of 0-100.

Trial Locations

Locations (3)

Azienda Ospedaliera Papa Giovanni XXIII; 🇮🇹 Bergamo, Lombardia, Italy

University General Hospital Attikon; 🇬🇷 Athens, Haidari, Greece

Ospedale Regionale di Lugano- Civico e Italiano; 🇨🇭 Lugano, Switzerland