SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Description

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.

Conditions

Spinal Fusion, Radiculopathy Lumbar, Chronic Pain

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Study Overview

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Study Details

Study overview

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.

SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Condition
Spinal Fusion
Intervention / Treatment

-

Contacts and Locations

Mishawaka

South Bend Orthopaedics, Mishawaka, Indiana, United States, 46544

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SynerFuse, Inc,

Study Record Dates

2024-10