Clinical trial NCT02525120: Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
Official title: Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lumbar Disc Herniation
Keywords: Disc herniation
Herniated disc
Triojection
Ozone
Lumbar spine
Leg pain
Lead sponsor: Minimus Spine, Inc
Sponsor class: OTHER
Collaborators: name: genae international,ag
First posted: 2015-08-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Leg pain NRS
timeFrame: Baseline, 1 week, 1, 3 and 6 months.
Secondary outcomes:
measure: Leg pain NRS
timeFrame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
measure: Back pain NRS
timeFrame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
measure: Functional Score measured by RMDI.
timeFrame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
measure: Quality of Life measured by EQ-5D
timeFrame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
measure: Patient Satisfaction via a survey
timeFrame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
measure: Cost Diary
timeFrame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
measure: Review of MRI images
timeFrame: Baseline and 6 and 24 months after treatment.
Other outcomes:
measure: Adverse Events
timeFrame: Through 24 months
Locations:
city: Athens
country: Greece
facility: University General Hospital Attikon
state: Haidari
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
state: Lombardia
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano- Civico e Italiano
Study officials:
affiliation: Centro Chirurgico San Paolo, Pistoia, Italy
name: Josip Buric, MD
role: STUDY_DIRECTOR
References: