Randomized Evaluation of Lumbar Injection Effectiveness and Function
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSpinaFX Medical Inc.
About this trial
The goal of this clinical trial is to learn whether the Triojection® System is safe and effective for treating symptomatic lumbar radiculopathy (leg pain caused by nerve irritation or compression) resulting from a contained herniated lumbar disc. The study will enroll adults 18 to 75 years of age with a single-level contained lumbar disc herniation who continue to have symptoms despite at least 6 weeks of non-surgical treatment and a previous lumbar spine injection.
The main questions it aims to answer are:
* Does treatment with the Triojection® System improve leg pain and overall clinical outcomes compared with Selective Nerve Root Block (SNRB) alone? * Is treatment with the Triojection® System safe, as measured by the absence of device- or procedure-related serious adverse events and persistent neurological deficits?
Researchers will compare participants who receive Triojection® followed by SNRB with participants who receive SNRB alone to determine whether the investigational treatment provides improved clinical outcomes.
Participants will:
* Be randomly assigned to receive either Triojection® plus SNRB or SNRB alone. * Complete questionnaires about leg pain, back pain, disability, quality of life, sleep, anxiety, depression, and overall improvement. * Undergo physical and neurological examinations during study follow-up visits. * Have MRI scans performed at selected study visits to evaluate changes in the treated disc. * Attend follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment.
Up to 300 participants will be enrolled at up to 30 investigational sites in the United States and Canada and followed for approximately 24 months after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between ≥18 (skeletally mature) - 75 (inclusive)
A single contained posterior lumbar disc herniation, at a single level L1-S1, no greater than 30% of the canal size confirmed by radiographic imaging (via MRI/Axial MRI sequence)
Has a preoperative leg VAS ≥ 50 /100 mm in worse leg AND worse leg is at least 20mm greater than the other leg
The target level herniated disc must have a disc height of at least 33% (1/3) that of the adjacent disc levels, as determined by the investigator
Disqualifiers
Evidence of a symptomatic lumbar herniation at more than one level confirmed by patient history and radiographic imaging (via MRI)
Functional neurological deficit evident during neurological exam such as drop foot, incontinence, intractable pain, loss of bladder or bowel control, or rapidly worsening symptoms
Previous spine surgery in the lumbar region involving the index or adjacent level disc as evident on MRI, or instrumented hardware (e.g., total disc replacement, fusion) at any lumbar spine level
Earlier spinal procedures in the lumbar region involving the index or adjacent level discs (basal nerve ablation, radiofrequency ablation, MILD procedure)
Trial design
Design model
Parallel
Treatments tested in this trial
Triojection® System
DeviceThe Triojection® System is an investigational device that generates and delivers 12 mL of an ozone-oxygen gas mixture at a concentration of 35 ± 3 µg/mL ozone in oxygen for image-guided intradiscal injection into a contained herniated lumbar disc.
Selective Nerve Root Block (SNRB)
Procedure/SurgeryImage-guided injection of dexamethasone and 0.25% bupivacaine (Marcaine) around the affected lumbar nerve root as standard of care treatment for lumbar radiculopathy. These arm and intervention entries follow the standard ClinicalTrials.gov format for a randomized device study with an active comparator.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Investigational: Triojection® System + Selective Nerve Root Block (SNRB)Experimental treatment 2 interventions
Group B: Active Comparator: Selective Nerve Root Block (SNRB) AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite Clinical Success at 6 Months
Composite clinical success at 6 months requiring achievement of all of the following components: * Improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline * Freedom from reintervention or conversion to surgery at the index level * Freedom from device- or procedure-related serious adverse events (SAEs) or persistent new or worsening neurological deficit
Time frame
6 MonthsSecondary outcomes
1
ODI Responder Rate at 6 Months
Proportion of participants achieving an improvement of at least 15 points in Oswestry Disability Index (ODI) score compared with baseline.
Time frame
6 Months2
Leg Pain Responder Rate at 6 Months
Proportion of participants achieving an improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline.
Time frame
6 Months3
Incidence of Related Adverse Events and Serious Adverse Events
Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs).
Time frame
Through 24 MonthsOther outcomes
1
Pain Response at 12 Months
Proportion of participants achieving at least a 20 mm improvement in worse-leg VAS pain score compared with baseline.
Time frame
12 Months2
ODI Responder Rate at 12 Months
Proportion of participants achieving an improvement of at least 15 points in ODI score compared with baseline.
Time frame
12 Months3
Patient Global Impression of Change (PGIC)
Participant-reported overall change following treatment.
Time frame
1, 3, 6, and 12 Months4
Change in ODI Score
Change from baseline in Oswestry Disability Index score.
Time frame
6 and 12 MonthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SpinaFX Medical Inc.
Lead sponsor
IQVIA Inc.
Collaborator
Source ClinicalTrials.gov
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