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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRG Neurostimulation with Spinal Fusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRG Neurostimulation with Spinal Fusion | Device | 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). |
| 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 |
| 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). |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabi Molnar | Contact | 612-217-2914 | Gabi@SynerFuse.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Bend Orthopaedics | Recruiting | Mishawaka | Indiana | 46544 | United States |
There are no plans to make the IPD available to other researchers.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013123 | Spinal Fusion |
| ID | Term |
|---|---|
| D001174 | Arthrodesis |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Single group
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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 |
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 |
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |