SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Spinal Fusion; Radiculopathy Lumbar
• Intervention / Treatment: Device: DRG Neurostimulation with Spinal Fusion

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabi Molnar; Phone Number: 612-217-2914; Email: Gabi@SynerFuse.com

Study Locations

• United States
  • Indiana
    • Mishawaka, Indiana, United States, 46544
      • Recruiting
      • South Bend Orthopaedics
      • Contact: Derek Yocum, PhD; Phone Number: 574-247-9441; Email: ClinicalResearch@sbortho.com
      • Principal Investigator: Deepak Reddy, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Kristin Frenn; Email: fren0108@umn.edu
      • Principal Investigator: Michael Park, MD, PhD
      • Sub-Investigator: Rohan Lall, MD
      • Sub-Investigator: Jonathan Sembrano, MD
      • Sub-Investigator: Matthew Hunt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DRG Neurostimulation with Spinal Fusion	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint: Characterization of device-related adverse events		Surgery through 12 months post-op
Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores	VAS scores range from 0 (no pain) to 100 (pain is as bad as it could possibly be). Decreases in scores indicate reductions in pain.	Baseline to 3 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in neurological status	Change in neurological status measured by the neurological component of the standard physical exam.	Baseline to 3, 6, and 12 months post-op
Change in disability measured by the Oswestry Disability Index (ODI).	Each question is scored from 0-5. The scores from each question are summed, then divided by the maximum number possible, then multiplied by 100 to represent a percentage. The percentages are broken down into 5 category ranges: 0% to 20%: minimal disability, 21%-40%: moderate disability; 41%-60%: severe disability; 61%-80%: crippled; 80%-100%: bed-bound or exagerating.	Baseline to 3, 6, and 12 months post-op
Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.	The is a 10-item patient-reported questionnaire in which the response options are presented as a 5-point rating scale. The results of the scores are are used to calculate two summary scores: a Global Physical Health score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score." The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	Baseline to 3, 6, and 12 months post-op
Change in quality of life as measured by EQ-5D-5L.	The EQ-5D-5L survey consists of 5 dimensions with the score for each ranging from 1 (no problems) to 5 (unable to do). For individual dimensions, negative changes (e.g. from 5 to 3) indicate improvement. The scores on these five dimensions will be presented as a health profile and converted to a single summary index number (utility). Positive changes in the total score indicate improvement.	Baseline to 3, 6, and 12 months post-op
Change in use of analgesics over time	Change in use of medications at all follow up visits.	Baseline through 12 months post-op

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of device migration	Amount of device migration as measured by anteroposterior (AP) and lateral x-rays.	Surgery to 3, 6, and 12 months post-op
Costs and cost-effectiveness of the intervention	The cost effectiveness analysis will report total healthcare-related expenditures reported by patients from baseline to 12 months post-op and 12 month quality-adjusted life-years (QALYs). Incremental cost per QALY will be estimated and compared to previously published studies.	Baseline through 12 months post-op

Collaborators and Investigators

• Sponsor: SynerFuse, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Failed Back Surgery Syndrome; Neurostimulation; Dorsal Root Ganglion
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Radiculopathy
• Other Study ID Numbers: G190045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to make the IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes