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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Device: Triojection; Procedure: Surgical discectomy

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Haidari
    • Athens, Haidari, Greece, 12462
      • University General Hospital Attikon
• Italy
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • Azienda Ospedaliera Papa Giovanni XXIII
• Switzerland
  • Lugano, Switzerland, 6900
    • Ospedale Regionale di Lugano- Civico e Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Triojection; Triojection is system intended to deliver a specific amount of ozone to a herniated disc.
Active Comparator: Surgical discectomy; The surgical group will be receive a standard surgical discectomy to remove the herniated disc material.	Procedure: Surgical discectomy; Patients will receive surgery to remove the herniated disc material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg pain NRS	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.	Baseline, 1 week, 1, 3 and 6 months.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	All adverse events are to be reported, per ISO 14155.	Through 24 months

Collaborators and Investigators

• Sponsor: Minimus Spine, Inc
• Collaborators: genae international,ag
• Investigators: Study Director: Josip Buric, MD, Centro Chirurgico San Paolo, Pistoia, Italy

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Disc herniation; Lumbar spine; Leg pain; Ozone; Herniated disc; Triojection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 1CP-1