Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
|Lumbar Disc Herniation||Device: Triojection Procedure: Surgical discectomy||Phase 4|
|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|
- 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.
- 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.
- Adverse Events [ Time Frame: Through 24 months ]All adverse events are to be reported, per ISO 14155.
|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)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02525120
|Contact: David M Hooper, Ph.D.||email@example.com|
|Contact: Amélie Vanneste, MSc||+32 3 290 03 firstname.lastname@example.org|
|University General Hospital Attikon||Recruiting|
|Athens, Haidari, Greece, 12462|
|Contact: Alexis Kelekis, MD email@example.com|
|Principal Investigator: Alexis Kelekis, MD|
|Azienda Ospedaliera Papa Giovanni XXIII||Recruiting|
|Bergamo, Lombardia, Italy, 24127|
|Contact: Cristina Piffari firstname.lastname@example.org|
|Principal Investigator: Giuseppe Bonaldi, MD|
|Ospedale Regionale di Lugano- Civico e Italiano||Recruiting|
|Lugano, Switzerland, 6900|
|Contact: Lorenzo Baldecchi email@example.com|
|Principal Investigator: Alessandro Cianfoni, MD|
|Study Director:||Josip Buric, MD||Centro Chirurgico San Paolo, Pistoia, Italy|