Chronic Pain Clinical Trial
Official title:
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
NCT number | NCT04054401 |
Other study ID # | G190045 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 6, 2022 |
Est. completion date | October 2024 |
Verified date | November 2023 |
Source | SynerFuse, Inc |
Contact | Gabi Molnar |
Phone | 612-217-2914 |
Gabi[@]SynerFuse.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
United States | South Bend Orthopaedics | Mishawaka | Indiana |
Lead Sponsor | Collaborator |
---|---|
SynerFuse, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Primary | Primary Safety Endpoint: Characterization of device-related adverse events | Surgery through 12 months post-op | ||
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change in use of analgesics over time | Change in use of medications at all follow up visits. | Baseline through 12 months post-op |
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