SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Not Applicable

Recruiting

• Conditions: Radiculopathy Lumbar; Spinal Fusion; Chronic Pain
• Interventions: Device: DRG Neurostimulation with Spinal Fusion

• Registration Number: NCT04054401
• Lead Sponsor: SynerFuse, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Study Start: 2022-01-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DRG Neurostimulation with Spinal Fusion	DRG Neurostimulation with Spinal Fusion	-

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life as measured by EQ-5D-5L.	Baseline to 3, 6, and 12 months post-op	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 neurological status	Baseline to 3, 6, and 12 months post-op	Change in neurological status measured by the neurological component of the standard physical exam.
Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.	Baseline to 3, 6, and 12 months post-op	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 disability measured by the Oswestry Disability Index (ODI).	Baseline to 3, 6, and 12 months post-op	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 use of analgesics over time	Baseline through 12 months post-op	Change in use of medications at all follow up visits.

Trial Locations

Locations (2)

South Bend Orthopaedics; 🇺🇸 Mishawaka, Indiana, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States