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Multicenter Retrospective Review of Safety and Efficacy of a Novel Minimally Invasive Lumbar Interspinous Fusion Device

Authors
  • Falowski, Steven M1
  • Mangal, Vipul2
  • Pope, Jason3
  • Patel, Anish4
  • Coleman, Mark5
  • Kendall, Dan6
  • Brouillette, Richard7
  • Fishman, Michael A8
  • 1 Neurosurgical Associates of Lancaster, Lancaster, PA
  • 2 National Spine and Pain, National Harbor, MD
  • 3 Evolve Restoration, Santa Rosa, CA
  • 4 National Spine and Pain, Frederick, MD
  • 5 National Spine and Pain, Pikesville, MD
  • 6 National Spine and Pain, McLean, VA
  • 7 National Spine and Pain, White Plains, MD
  • 8 Center for Interventional Pain and Spine, Lancaster, PA
Type
Published Article
Journal
Journal of Pain Research
Publisher
Dove Medical Press
Publication Date
May 31, 2021
Volume
14
Pages
1525–1531
Identifiers
DOI: 10.2147/JPR.S304957
PMID: 34103977
PMCID: PMC8180294
Source
PubMed Central
Keywords
Disciplines
  • Original Research
License
Unknown

Abstract

Introduction Several treatment options exist for those with spinal stenosis, as well as degenerative changes. This series evaluates the use of an interspinous fixation (ISF) device as performed by interventional pain physicians. Methods This is a retrospective analysis identifying 32 patients with the diagnosis of lumbar degenerative disc disease with secondary diagnosis of lumbar spinal stenosis being treated with ISF with Aurora Spine Zip Interspinous Spacer. Serious adverse events, specifically nerve injury, hematoma, infection, and death, were analyzed quantitatively for reported complications within 90 days from the procedure. In addition, VAS was analyzed for patient reported outcomes. Results Adverse event rate was 0% with no incidences of reoperation, or device removal. Estimated blood loss was recorded as less than 50 cc for all patients. The preoperative pain assessment demonstrated an average pain score of 8.1 and a postoperative pain score of 2.65 equating to a percentage pain reduction of 67%. Conclusion This case series demonstrates the success and safety of ISF being performed by interventional pain physicians in an outpatient setting. It is a valuable tool in the treatment of moderate to severe lumbar spinal stenosis and degenerative disc disease that has decreased morbidity and significant efficacy.

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