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SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

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This study will test the completion of a fusion and implantation of a neuromodulation device during the same open back procedure.

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Male or Female
18 Years and over
Inclusion Criteria:
Description: This is a 12-month long study of patients between ages 21-79 years old with chronic lower back pain who have been told by a doctor that they should have a single level spinal fusion surgery to address their pain. Despite successful surgery, up to 40% of patients who have had a spinal fusion surgery can experience long-term residual back pain. This study is trying to figure out if this pain can be addressed in a safe and effective way earlier by combining two established treatments into a single procedure. It involves implanting a neuromodulation device during the spinal fusion procedure and starting the neurostimulation during the hospital stay, instead of implanting the device during a separate procedure that typically happens years later.

Chronic Lower Back Pain, DRG, Neurostimulation, Spinal Fusion

Kristin Frenn - fren0108@umn.edu
Michael Park
STUDY00004880
STUDY00004880

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