SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
NCT ID: NCT04054401
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-01-06
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DRG Neurostimulation with Spinal Fusion
DRG Neurostimulation with Spinal Fusion
Surgeons will implant a neurostimulator during the same open back procedure as fusion devices (spinal fusion hardware and interbody cage) and begin neurostimulation in a short time following surgery (24 hours).
Interventions
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DRG Neurostimulation with Spinal Fusion
Surgeons will implant a neurostimulator during the same open back procedure as fusion devices (spinal fusion hardware and interbody cage) and begin neurostimulation in a short time following surgery (24 hours).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
80 Years
ALL
No
Sponsors
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SynerFuse, Inc
OTHER
Responsible Party
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Locations
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South Bend Orthopaedics
Mishawaka, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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G190045
Identifier Type: -
Identifier Source: org_study_id