SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

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.

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