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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
49
Triojection is system intended to deliver a specific amount of ozone to a herniated disc.
Patients will receive surgery to remove the herniated disc material.
University General Hospital Attikon
Athens, Haidari, Greece
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Ospedale Regionale di Lugano- Civico e Italiano
Lugano, Switzerland
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.
Time frame: Baseline, 1 week, 1, 3 and 6 months.
Leg pain NRS
Leg pain Numerical Rating Scale (NRS) at each visit.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Baseline and 6 and 24 months after treatment.