SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.

Official Title
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SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Conditions
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Spinal Fusion, Radiculopathy Lumbar, Chronic Pain

Intervention / Treatment
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* Device: DRG Neurostimulation with Spinal Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months At least 6 months since last surgical procedure on the spine Be 21 years of age or older at the time of enrollment Be willing and capable of giving informed consent Be willing and able to comply with study-related requirements Exclusion Criteria: Any prior spinal fusion at index or adjacent level Pregnant Have a life expectancy of less than 1 year Be concomitantly participating in another clinical study Be involved in an injury claim under current litigation Baseline narcotic use of ≥ 100 MME per day Significant untreated addiction to dependency producing medications Current active implantable medical device Cancer Have osteoporosis Active infection Allergies to system components AGE > 80 Expected need to undergo MRI imaging in the future Other significant comorbidities

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRG Neurostimulation with Spinal Fusion<br> | Device: DRG Neurostimulation with Spinal Fusion<br>* Surgeons will implant a neurostimulator during the same open back procedure as fusion devices (spinal fusion hardware and interbody cage) and begin neurostimulation in a short time following surgery (24 hours).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint: Characterization of device-related adverse events |  | Surgery through 12 months post-op | 
| Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores | VAS scores range from 0 (no pain) to 100 (pain is as bad as it could possibly be). Decreases in scores indicate reductions in pain. | Baseline to 3 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neurological status | Change in neurological status measured by the neurological component of the standard physical exam. | Baseline to 3, 6, and 12 months post-op | 
| Change in disability measured by the Oswestry Disability Index (ODI). | Each question is scored from 0-5. The scores from each question are summed, then divided by the maximum number possible, then multiplied by 100 to represent a percentage. The percentages are broken down into 5 category ranges: 0% to 20%: minimal disability, 21%-40%: moderate disability; 41%-60%: severe disability; 61%-80%: crippled; 80%-100%: bed-bound or exagerating. | Baseline to 3, 6, and 12 months post-op | 
| Change in quality of life as measured by PROMIS Scale v1.2 - Global Health. | The is a 10-item patient-reported questionnaire in which the response options are presented as a 5-point rating scale. The results of the scores are are used to calculate two summary scores: a Global Physical Health score and a Global Mental Health score. These scores are then standardized to the general population, using the T-Score. The average T-Score for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | Baseline to 3, 6, and 12 months post-op | 
| Change in quality of life as measured by EQ-5D-5L. | The EQ-5D-5L survey consists of 5 dimensions with the score for each ranging from 1 (no problems) to 5 (unable to do). For individual dimensions, negative changes (e.g. from 5 to 3) indicate improvement. The scores on these five dimensions will be presented as a health profile and converted to a single summary index number (utility). Positive changes in the total score indicate improvement. | Baseline to 3, 6, and 12 months post-op | 
| Change in use of analgesics over time | Change in use of medications at all follow up visits. | Baseline through 12 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dorsal Root Ganglion, Neurostimulation, Failed Back Surgery Syndrome