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

Primary Purpose

Lumbar Disc Herniation

Status

Unknown status

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Triojection

Surgical discectomy

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Disc herniation, Herniated disc, Triojection, Ozone, Lumbar spine, Leg pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Patient is willing to provide informed consent.
Clinical and radiographic evidence of one, and only one, symptomatic protruding or extruded disc between L1 and S1.
The herniated disc should have a disc height of at least 50% that of the normal adjacent disc levels, as determined by the investigator.
The signal intensity of the herniated disc material should be equal or greater than the nucleus pulposus of the herniated disc.
The patient must have pain in a dermatomal distribution consistent with their radiographic findings
Leg pain greater than or equal to 5 on the NRS scale
Symptoms for at least 6 weeks
Willingness to complete all follow-up evaluations
Patient aged 18-65 years
BMI<40

Exclusion Criteria:

Patients with a disc herniation extending past the facet joint
Presence of a non-contiguous disc fragment
Impairment of bladder/bowel function or motor impairment in the affected leg
An epidural steroid injection in the past 2 weeks
Previous discectomy, arthroplasty or fusion at any lumbar level
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.
Symptomatic lumbar stenosis or listhesis
Symptomatic sacroiliac joint
Symptomatic foraminal stenosis due to severe degenerative disc disease
History of spinal tumor, fracture or infection
Females of childbearing age that are known to be pregnant or wishing to become pregnant during the study
Fibromyalgia
Active infection
Metastatic cancer within the past 5 years
Pending litigation against a health care provider
More than 3 months of continuous sick leave prior to enrollment.
Known drug or alcohol abuse
Diagnosed psychiatric disease or psychological distress caused by recent trauma like divorce, death of a member family or loss of a job
Patient known to be affected by favism (G6PD deficiency)

Sites / Locations

University General Hospital Attikon
Azienda Ospedaliera Papa Giovanni XXIII
Ospedale Regionale di Lugano- Civico e Italiano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Triojection System for ozone injection

Surgical discectomy

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Leg pain NRS

Leg pain Numerical Rating Scale (NRS) at each visit.

Back pain NRS

Back pain Numerical Rating Scale (NRS) at each visit

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.

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.

Patient Satisfaction via a survey

Brief questionnaire asking patients to rate their level of satisfaction.

Cost Diary

Survey asking patients to detail their medical expenses, work status, time off work etc.

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.

Full Information

NCT ID

NCT02525120

First Posted

August 12, 2015

Last Updated

June 4, 2018

Sponsor

Minimus Spine, Inc

Collaborators

genae international,ag

1. Study Identification

Unique Protocol Identification Number

NCT02525120

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Minimus Spine, Inc

Collaborators

genae international,ag

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Disc Herniation

Keywords

Disc herniation, Herniated disc, Triojection, Ozone, Lumbar spine, Leg pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Triojection System for ozone injection

Arm Type

Experimental

Arm Description

Arm Title

Surgical discectomy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Triojection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgical discectomy

Intervention Description

Patients will receive surgery to remove the herniated disc material.

Primary Outcome Measure Information:

Title

Leg pain NRS

Description

Time Frame

Baseline, 1 week, 1, 3 and 6 months.

Secondary Outcome Measure Information:

Title

Leg pain NRS

Description

Leg pain Numerical Rating Scale (NRS) at each visit.

Time Frame