Recruiting

SynerFuse

Sponsor:

SynerFuse, Inc

Code:

NCT04054401

Conditions

Spinal Fusion

Radiculopathy Lumbar

Chronic Pain

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

DRG Neurostimulation with Spinal Fusion

Study Details

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 interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.

Conditions

Spinal Fusion

Radiculopathy Lumbar

Chronic Pain

Study ID

NCT04054401

Start date

Jan 6, 2022

Status verified date

Nov, 2023

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DRG Neurostimulation with Spinal Fusion

Interventions

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).

Primary outcome measure

  • Primary Safety Endpoint: Characterization of device-related adverse events [ Time Frame: Surgery through 12 months post-op ]
  • Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores [ Time Frame: Baseline to 3 months post-op ]

Central Contacts and Locations

Central contacts

Gabi Molnar

612-217-2914Gabi@SynerFuse.com

Locations

South Bend Orthopaedics

Recruiting

Mishawaka, Indiana, United States, 46544

Contacts

Derek Yocum, PhD

574-247-9441ClinicalResearch@sbortho.com

Principal Investigator:

Deepak Reddy, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Kristin Frenn

fren0108@umn.edu

Principal Investigator:

Michael Park, MD, PhD

More Information

Sponsor

SynerFuse, Inc

Last update posted

Nov 24, 2023

Last verified

Nov, 2023

Keywords

  • Dorsal Root Ganglion
  • Neurostimulation
  • Failed Back Surgery Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by SynerFuse, Inc on 2023-11-24.