Back to resultsSynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
Primary Purpose
Spinal Fusion, Radiculopathy Lumbar, Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DRG Neurostimulation with Spinal Fusion
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Fusion focused on measuring Dorsal Root Ganglion, Neurostimulation, Failed Back Surgery Syndrome
Eligibility Criteria
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
Sites / Locations
- South Bend OrthopaedicsRecruiting
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DRG Neurostimulation with Spinal Fusion
Arm Description
Outcomes
Primary Outcome Measures
Primary Safety Endpoint: Characterization of device-related adverse events
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.
Secondary Outcome Measures
Change in neurological status
Change in neurological status measured by the neurological component of the standard physical exam.
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.
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.
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.
Change in use of analgesics over time
Change in use of medications at all follow up visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04054401
Brief Title
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
Official Title
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SynerFuse, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fusion, Radiculopathy Lumbar, Chronic Pain
Keywords
Dorsal Root Ganglion, Neurostimulation, Failed Back Surgery Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DRG Neurostimulation with Spinal Fusion
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
DRG Neurostimulation with Spinal Fusion
Intervention Description
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 Information:
Title
Primary Safety Endpoint: Characterization of device-related adverse events
Time Frame
Surgery through 12 months post-op
Title
Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores
Description
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.
Time Frame
Baseline to 3 months post-op
Secondary Outcome Measure Information:
Title
Change in neurological status
Description
Change in neurological status measured by the neurological component of the standard physical exam.
Time Frame
Baseline to 3, 6, and 12 months post-op
Title
Change in disability measured by the Oswestry Disability Index (ODI).
Description
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.
Time Frame
Baseline to 3, 6, and 12 months post-op
Title
Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.
Description
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.
Time Frame
Baseline to 3, 6, and 12 months post-op
Title
Change in quality of life as measured by EQ-5D-5L.
Description
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.
Time Frame
Baseline to 3, 6, and 12 months post-op
Title
Change in use of analgesics over time
Description
Change in use of medications at all follow up visits.
Time Frame
Baseline through 12 months post-op
Other Pre-specified Outcome Measures:
Title
Amount of device migration
Description
Amount of device migration as measured by anteroposterior (AP) and lateral x-rays.
Time Frame
Surgery to 3, 6, and 12 months post-op
Title
Costs and cost-effectiveness of the intervention
Description
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.
Time Frame
Baseline through 12 months post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabi Molnar
Phone
612-217-2914
Email
Gabi@SynerFuse.com
Facility Information:
Facility Name
South Bend Orthopaedics
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek Yocum, PhD
Phone
574-247-9441
Email
ClinicalResearch@sbortho.com
First Name & Middle Initial & Last Name & Degree
Deepak Reddy, MD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Frenn
Email
fren0108@umn.edu
First Name & Middle Initial & Last Name & Degree
Michael Park, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rohan Lall, MD
First Name & Middle Initial & Last Name & Degree
Jonathan Sembrano, MD
First Name & Middle Initial & Last Name & Degree
Matthew Hunt, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to make the IPD available to other researchers.
Learn more about this trial
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
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