Lumbar Disc HerniationPhase 4NCT02525120
Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
A Phase 4 study testing Triojection and Surgical discectomy in people with Lumbar Disc Herniation, run by Minimus Spine, Inc at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Triojection and Surgical discectomy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2015to May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is willing to provide informed consent.
- Clinical and radiographic evidence of one, and only one, symptomatic protruding or extruded disc between L1 and S1.
- The herniated disc should have a disc height of at least 50% that of the normal adjacent disc levels, as determined by the investigator.
- The signal intensity of the herniated disc material should be equal or greater than the nucleus pulposus of the herniated disc.
- The patient must have pain in a dermatomal distribution consistent with their radiographic findings
- Leg pain greater than or equal to 5 on the NRS scale
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- Symptoms for at least 6 weeks
- Willingness to complete all follow-up evaluations
- Patient aged 18-65 years
- BMI<40
Who cannot join
- Patients with a disc herniation extending past the facet joint
- Presence of a non-contiguous disc fragment
- Impairment of bladder/bowel function or motor impairment in the affected leg
- An epidural steroid injection in the past 2 weeks
- Previous discectomy, arthroplasty or fusion at any lumbar level
- 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.
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- Symptomatic lumbar stenosis or listhesis
- Symptomatic sacroiliac joint
- Symptomatic foraminal stenosis due to severe degenerative disc disease
- History of spinal tumor, fracture or infection
- Females of childbearing age that are known to be pregnant or wishing to become pregnant during the study
- Fibromyalgia
- Active infection
- Metastatic cancer within the past 5 years
- Pending litigation against a health care provider
- More than 3 months of continuous sick leave prior to enrollment.
- Known drug or alcohol abuse
- Diagnosed psychiatric disease or psychological distress caused by recent trauma like divorce, death of a member family or loss of a job
- Patient known to be affected by favism (G6PD deficiency)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Switzerland1 site
Ospedale Regionale di Lugano- Civico e Italiano
Lugano, 6900
About this study
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.
Read the 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Triojection, Surgical discectomy
- Keywords
- Disc herniation, Herniated disc, Triojection, Ozone, Lumbar spine, Leg pain
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriojectionDevice
Triojection is system intended to deliver a specific amount of ozone to a herniated disc.
Surgical discectomyProcedure or surgery
Patients will receive surgery to remove the herniated disc material.
| Study group | Role | What they receive |
|---|---|---|
| Triojection System for ozone injection | Experimental | 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. Receives: Device: Triojection |
| Surgical discectomy | Active comparator | The surgical group will be receive a standard surgical discectomy to remove the herniated disc material. Receives: Procedure: Surgical discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 1, 3 and 6 months.
Secondary outcomes (7)
Leg pain NRS
Leg pain Numerical Rating Scale (NRS) at each visit.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 and 24 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2018 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minimus Spine, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- genae international,ag
- Responsible party
- Sponsor
- Investigators
- Josip Buric, MD, Study director, Centro Chirurgico San Paolo, Pistoia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525120
- Sponsor's protocol ID
- 1CP-1
- Status last verified
- Jun 2018
- First submitted
- 12 Aug 2015
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT02525120
- Acronym / sponsor ID
- 1CP-1
- Conditions
- Lumbar Disc Herniation
- Keywords
- Disc herniation, Herniated disc, Triojection, Ozone, Lumbar spine, Leg pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Minimus Spine, IncUniversity, hospital or other
- Collaborators
- genae international,ag
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triojection System for ozone injection | Experimental | Device: TriojectionTriojection 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. |
| Surgical discectomy | Active comparator | Procedure: Surgical discectomyThe surgical group will be receive a standard surgical discectomy to remove the herniated disc material. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is willing to provide informed consent.
- Clinical and radiographic evidence of one, and only one, symptomatic protruding or extruded disc between L1 and S1.
- The herniated disc should have a disc height of at least 50% that of the normal adjacent disc levels, as determined by the investigator.
- The signal intensity of the herniated disc material should be equal or greater than the nucleus pulposus of the herniated disc.
- The patient must have pain in a dermatomal distribution consistent with their radiographic findings
Key exclusion criteria (19 listed)
- Patients with a disc herniation extending past the facet joint
- Presence of a non-contiguous disc fragment
- Impairment of bladder/bowel function or motor impairment in the affected leg
- An epidural steroid injection in the past 2 weeks
- Previous discectomy, arthroplasty or fusion at any lumbar level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriojectionTriojection is system intended to deliver a specific amount of ozone to a herniated disc. | Device | Triojection System for ozone injection |
| Surgical discectomyPatients will receive surgery to remove the herniated disc material. | Procedure or surgery | Surgical discectomy |
Primary outcome
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.
7 secondary outcomes
Leg pain NRS
Time frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Back pain NRS
Time frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Functional Score measured by RMDI.
Time frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Quality of Life measured by EQ-5D
Time frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Patient Satisfaction via a survey
Time frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Cost Diary
Time frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Review of MRI images
Time frame: Baseline and 6 and 24 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josip Buric, MD study director
Centro Chirurgico San Paolo, Pistoia, Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triojection and Surgical discectomy in people with Lumbar Disc Herniation, run by Minimus Spine, Inc at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg pain NRS (time frame: Baseline, 1 week, 1, 3 and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.