RECRUITING

SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

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Conditions

Spinal FusionRadiculopathy LumbarChronic PainDorsal Root GanglionNeurostimulationFailed Back Surgery Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Quick Facts

Study Start:2022-01-06
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04054401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy
  2. * Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months
  3. * At least 6 months since last surgical procedure on the spine
  4. * Be 21 years of age or older at the time of enrollment
  5. * Be willing and capable of giving informed consent
  6. * Be willing and able to comply with study-related requirements
  1. * Any prior spinal fusion at index or adjacent level
  2. * Pregnant
  3. * Have a life expectancy of less than 1 year
  4. * Be concomitantly participating in another clinical study
  5. * Be involved in an injury claim under current litigation
  6. * Baseline narcotic use of ≥ 100 MME per day
  7. * Significant untreated addiction to dependency producing medications
  8. * Current active implantable medical device
  9. * Cancer
  10. * Have osteoporosis
  11. * Active infection
  12. * Allergies to system components
  13. * AGE \> 80
  14. * Expected need to undergo MRI imaging in the future
  15. * Other significant comorbidities

Contacts and Locations

Study Contact

Gabi Molnar
CONTACT
612-217-2914
Gabi@SynerFuse.com

Study Locations (Sites)

South Bend Orthopaedics
Mishawaka, Indiana, 46544
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: SynerFuse, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-06
Study Completion Date2024-10

Study Record Updates

Study Start Date2022-01-06
Study Completion Date2024-10

Terms related to this study

Keywords Provided by Researchers

  • Dorsal Root Ganglion
  • Neurostimulation
  • Failed Back Surgery Syndrome

Additional Relevant MeSH Terms

  • Spinal Fusion
  • Radiculopathy Lumbar
  • Chronic Pain