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

NCT02525120 | Unknown Phase 4

• 1 other identifier: 1CP-1
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 3

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.

Conditions

Lumbar Disc Herniation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Leg pain NRS

  Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.

• Back pain NRS

  Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.

• Functional Score measured by RMDI.

  Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.

• Quality of Life measured by EQ-5D

  Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.

• Patient Satisfaction via a survey

  Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.

Other Outcomes (1)

• Adverse Events

  Through 24 months

Study Arms (2)

Triojection System for ozone injection

EXPERIMENTAL

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

Surgical discectomy

ACTIVE COMPARATOR

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

Procedure: Surgical discectomy

Interventions

Triojection DEVICE

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

Triojection System for ozone injection

Surgical discectomy PROCEDURE

Patients will receive surgery to remove the herniated disc material.

Surgical discectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minimus Spine, Inc: lead
• genae international,ag: collaborator

Study Sites (3)

University General Hospital Attikon

Athens, Haidari, 12462, Greece

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

Location

Ospedale Regionale di Lugano- Civico e Italiano

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Josip Buric, MD

  Centro Chirurgico San Paolo, Pistoia, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 17, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2020
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

IT (1); CH (1); GR (1)