SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

NCT04054401 | Unknown DMC FDA Device

• 1 other identifier: G190045
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Fusion; Radiculopathy Lumbar; Chronic Pain

Keywords

Dorsal Root Ganglion; Neurostimulation; Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Change in neurological status

  Baseline to 3, 6, and 12 months post-op

• Change in disability measured by the Oswestry Disability Index (ODI).

  Baseline to 3, 6, and 12 months post-op

• Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.

  Baseline to 3, 6, and 12 months post-op

• Change in quality of life as measured by EQ-5D-5L.

  Baseline to 3, 6, and 12 months post-op

• Change in use of analgesics over time

  Baseline through 12 months post-op

Other Outcomes (2)

• Amount of device migration

  Surgery to 3, 6, and 12 months post-op

• Costs and cost-effectiveness of the intervention

  Baseline through 12 months post-op

Study Arms (1)

DRG Neurostimulation with Spinal Fusion

EXPERIMENTAL

Device: DRG Neurostimulation with Spinal Fusion

Interventions

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).

DRG Neurostimulation with Spinal Fusion

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SynerFuse, Inc: lead

Study Sites (2)

South Bend Orthopaedics

Mishawaka, Indiana, 46544, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Failed Back Surgery Syndrome

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Back Pain

Intervention Hierarchy (Ancestors)

Arthrodesis; Orthopedic Procedures; Surgical Procedures, Operative

Central Study Contacts

Gabi Molnar

CONTACT

612-217-2914; Gabi@SynerFuse.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 13, 2019
• Study Start: January 6, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)