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Trial record 1 of 1 for:    Triojection
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Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Minimus Spine, Inc
Sponsor:
Collaborator:
genae international,ag
Information provided by (Responsible Party):
Minimus Spine, Inc
ClinicalTrials.gov Identifier:
NCT02525120
First received: August 12, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Lumbar Disc Herniation Device: Triojection Procedure: Surgical discectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation

Resource links provided by NLM:


Further study details as provided by Minimus Spine, Inc:

Primary Outcome Measures:
  • Leg pain NRS [ Time Frame: 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:
  • Leg pain NRS [ Time Frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment. ]
    Leg pain Numerical Rating Scale (NRS) at each visit.

  • Back pain NRS [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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.

  • Patient Satisfaction via a survey [ Time Frame: 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 [ Time Frame: 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.

  • Review of MRI images [ Time Frame: 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.


Other Outcome Measures:
  • Adverse Events [ Time Frame: Through 24 months ]
    All adverse events are to be reported, per ISO 14155.


Estimated Enrollment: 50
Study Start Date: July 2015
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02525120

Contacts
Contact: David M Hooper, Ph.D. 512-619-4855 david@minimusspine.com
Contact: Amélie Vanneste, MSc +32 3 290 03 06 amelie.vanneste@genae.com

Locations
Greece
University General Hospital Attikon Recruiting
Athens, Haidari, Greece, 12462
Contact: Alexis Kelekis, MD       akelekis@med.uoa.gr   
Principal Investigator: Alexis Kelekis, MD         
Italy
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Lombardia, Italy, 24127
Contact: Cristina Piffari       cpiffari@hpg23.it   
Principal Investigator: Giuseppe Bonaldi, MD         
Switzerland
Ospedale Regionale di Lugano- Civico e Italiano Recruiting
Lugano, Switzerland, 6900
Contact: Lorenzo Baldecchi       lorenzo.baldecchi@eoc.ch   
Principal Investigator: Alessandro Cianfoni, MD         
Sponsors and Collaborators
Minimus Spine, Inc
genae international,ag
Investigators
Study Director: Josip Buric, MD Centro Chirurgico San Paolo, Pistoia, Italy
  More Information

Responsible Party: Minimus Spine, Inc
ClinicalTrials.gov Identifier: NCT02525120     History of Changes
Other Study ID Numbers: 1CP-1
Study First Received: August 12, 2015
Last Updated: March 21, 2017

Keywords provided by Minimus Spine, Inc:
Disc herniation
Herniated disc
Triojection
Ozone
Lumbar spine
Leg pain

Additional relevant MeSH terms:
Hernia
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 27, 2017