SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

SynerFuse, Inc

Status: Enrolling

Conditions: Radiculopathy Lumbar; Chronic Pain; Spinal Fusion

Treatments: Device: DRG Neurostimulation with Spinal Fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04054401

G190045

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

DRG Neurostimulation with Spinal Fusion

Experimental group

Treatment:

Device: DRG Neurostimulation with Spinal Fusion