Spinal FusionNCT04054401
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
A study testing DRG Neurostimulation with Spinal Fusion in people with Spinal Fusion and Radiculopathy Lumbar, run by SynerFuse, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Spinal Fusion, Radiculopathy Lumbar, Chronic Pain
- What is being tested?
- DRG Neurostimulation with Spinal Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jan 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kristin Frenn, fren0108@umn.edu
Michael Park, MD, PhD
- Recruiting
South Bend Orthopaedics
Mishawaka, Indiana, 46544
Derek Yocum, PhD, 574-247-9441, ClinicalResearch@sbortho.com
Deepak Reddy, MD
About this 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.
- Conditions
- Spinal Fusion, Radiculopathy Lumbar, Chronic Pain
- Being tested
- DRG Neurostimulation with Spinal Fusion
- Keywords
- Dorsal Root Ganglion, Neurostimulation, Failed Back Surgery Syndrome
- Medical subject headings
- Chronic Pain, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRG Neurostimulation with Spinal FusionDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| DRG Neurostimulation with Spinal Fusion | Experimental | Not described Receives: Device: DRG Neurostimulation with Spinal Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Characterization of device-related adverse events
Measured: 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.
Measured: Baseline to 3 months post-op
Secondary outcomes (5)
Change in neurological status
Change in neurological status measured by the neurological component of the standard physical exam.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start6 Jan 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynerFuse, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054401
- Sponsor's protocol ID
- G190045
- Status last verified
- Nov 2023
- First submitted
- 30 Jul 2019
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans to make the IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04054401
- Acronym / sponsor ID
- G190045
- Conditions
- Spinal Fusion, Radiculopathy Lumbar, Chronic Pain
- Keywords
- Dorsal Root Ganglion, Neurostimulation, Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SynerFuse, IncUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group
| Arm | Type | Receives |
|---|---|---|
| DRG Neurostimulation with Spinal Fusion | Experimental | Device: DRG Neurostimulation with Spinal Fusion |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRG Neurostimulation with Spinal FusionSurgeons 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). | Device | DRG Neurostimulation with Spinal Fusion |
Primary outcome
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
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.
5 secondary outcomes
Change in neurological status
Time frame: Baseline to 3, 6, and 12 months post-op
Change in disability measured by the Oswestry Disability Index (ODI).
Time frame: Baseline to 3, 6, and 12 months post-op
Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.
Time frame: Baseline to 3, 6, and 12 months post-op
Change in quality of life as measured by EQ-5D-5L.
Time frame: Baseline to 3, 6, and 12 months post-op
Change in use of analgesics over time
Time frame: Baseline through 12 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No. There are no plans to make the IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DRG Neurostimulation with Spinal Fusion in people with Spinal Fusion and Radiculopathy Lumbar, run by SynerFuse, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabi Molnar (612-217-2914, Gabi@SynerFuse.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Characterization of device-related adverse events (time frame: Surgery through 12 months post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.