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

Steven M Falowski; Vipul Mangal; Jason Pope; Anish Patel; Mark Coleman; Dan Kendall; Richard Brouillette; Michael A Fishman

doi:10.2147/JPR.S304957

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

J Pain Res. 2021 May 31:14:1525-1531. doi: 10.2147/JPR.S304957. eCollection 2021.

Authors

Steven M Falowski¹, Vipul Mangal², Jason Pope³, Anish Patel⁴, Mark Coleman⁵, Dan Kendall⁶, Richard Brouillette⁷, Michael A Fishman⁸

Affiliations

¹ Neurosurgical Associates of Lancaster, Lancaster, PA, USA.
² National Spine and Pain, National Harbor, MD, USA.
³ Evolve Restoration, Santa Rosa, CA, USA.
⁴ National Spine and Pain, Frederick, MD, USA.
⁵ National Spine and Pain, Pikesville, MD, USA.
⁶ National Spine and Pain, McLean, VA, USA.
⁷ National Spine and Pain, White Plains, MD, USA.
⁸ Center for Interventional Pain and Spine, Lancaster, PA, USA.

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.

Keywords: indirect decompression; interspinous fixation; interspinous fusion; interspinous spacer; lumbar degenerative disc disease; lumbar stenosis; spinal fusion; spinal stenosis.

Grants and funding

There was no financial support for this document.