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

• Main Authors: Falowski SM, Mangal V, Pope J, Patel A, Coleman M, Kendall D, Brouillette R, Fishman MA
• Format: Article
• Language: English
• Published: Dove Medical Press 2021-05-01
• Series: Journal of Pain Research
• Subjects: interspinous spacer; indirect decompression; interspinous fusion; interspinous fixation; lumbar degenerative disc disease; spinal stenosis; lumbar stenosis; spinal fusion
• Online Access: https://www.dovepress.com/multicenter-retrospective-review-of-safety-and-efficacy-of-a-novel-min-peer-reviewed-fulltext-article-JPR

Steven M Falowski,1 Vipul Mangal,2 Jason Pope,3 Anish Patel,4 Mark Coleman,5 Dan Kendall,6 Richard Brouillette,7 Michael A Fishman8 1Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 2National Spine and Pain, National Harbor, MD, USA; 3Evolve Restoration, Santa Rosa, CA, USA; 4National Spine and Pain, Frederick, MD, USA; 5National Spine and Pain, Pikesville, MD, USA; 6National Spine and Pain, McLean, VA, USA; 7National Spine and Pain, White Plains, MD, USA; 8Center for Interventional Pain and Spine, Lancaster, PA, USACorrespondence: Steven M FalowskiDirector Functional Neurosurgery, Neurosurgical Associates of Lancaster, 160 N Pointe Blvd Suite 200, Lancaster, PA, 17601, USATel [phone]Email [e-mail]: 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: interspinous spacer, indirect decompression, interspinous fusion, interspinous fixation, lumbar degenerative disc disease, spinal stenosis, lumbar stenosis, spinal fusion