Lumbar Disc Herniation
Conditions
Keywords
Disc herniation, Herniated disc, Triojection, Ozone, Lumbar spine, Leg pain
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.
Interventions
DEVICETriojection
Triojection is system intended to deliver a specific amount of ozone to a herniated disc.
PROCEDURESurgical discectomy
Patients will receive surgery to remove the herniated disc material.
Sponsors
genae international,ag
Minimus Spine, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg pain NRS | 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
| Measure | Time frame | Description |
|---|---|---|
| Leg pain NRS | 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 | 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. | 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. |
| Patient Satisfaction via a survey | 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 | 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 | 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. |
| Quality of Life measured by EQ-5D | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Through 24 months | All adverse events are to be reported, per ISO 14155. |
Countries
Greece, Italy, Switzerland
Outcome results
None listed