Status:
UNKNOWN
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
Lead Sponsor:
SynerFuse, Inc
Conditions:
Spinal Fusion
Radiculopathy Lumbar
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
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 inter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04054401
Start Date
January 6 2022
End Date
October 1 2024
Last Update
November 24 2023
Active Locations (2)
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1
South Bend Orthopaedics
Mishawaka, Indiana, United States, 46544
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455