SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Status unconfirmed · Not applicable

Conditions studied: Spinal Fusion, Radiculopathy Lumbar, Chronic Pain

In brief

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.

Key facts

Study ID

NCT04054401

Run by

SynerFuse, Inc

People needed

20

Starts

2022-01-06

Expected to finish

2024-10-01

Last updated by the study team

2023-11-24

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• South Bend Orthopaedics — Mishawaka, Indiana, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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