Clinical trial NCT04054401: SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
Official title: SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Fusion
Radiculopathy Lumbar
Chronic Pain
Keywords: Dorsal Root Ganglion
Neurostimulation
Failed Back Surgery Syndrome
Lead sponsor: SynerFuse, Inc
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint: Characterization of device-related adverse events
timeFrame: Surgery through 12 months post-op
measure: Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores
timeFrame: Baseline to 3 months post-op
Secondary outcomes:
measure: Change in neurological status
timeFrame: Baseline to 3, 6, and 12 months post-op
measure: Change in disability measured by the Oswestry Disability Index (ODI).
timeFrame: Baseline to 3, 6, and 12 months post-op
measure: Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.
timeFrame: Baseline to 3, 6, and 12 months post-op
measure: Change in quality of life as measured by EQ-5D-5L.
timeFrame: Baseline to 3, 6, and 12 months post-op
measure: Change in use of analgesics over time
timeFrame: Baseline through 12 months post-op
Other outcomes:
measure: Amount of device migration
timeFrame: Surgery to 3, 6, and 12 months post-op
measure: Costs and cost-effectiveness of the intervention
timeFrame: Baseline through 12 months post-op
Locations:
city: Mishawaka
country: United States
facility: South Bend Orthopaedics
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: