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

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.

Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN)

“…There were no prospective RCTs evaluating the efficacy of ISF alone during the development of this manuscript. Some moderate-to-large scale retrospective reviews evaluated the efficacy of interspinous spacers with lumbar decompression; 106 , 107 however, evidence supporting the use of ISF as a stand-alone procedure to benefit patients with lumbar stenosis remains limited. A multicenter single-arm prospective study is currently enrolling patients with degenerative disc disease in the presence of NC and spinal stenosis.…”

“…More recently, a retrospective review of safety and efficacy of ISF using a novel device was performed by Falowski et al, who studied 32 patients. 107 The consecutive patient case series demonstrated the experience of four implanting interventional pain physicians who performed minimally invasive ISF in an outpatient ambulatory surgical center (ASC) for patients demonstrating low back pain and NC symptoms with imaging findings consistent with moderate-severe degenerative LSS at one or two levels. This was a retrospective review noting a significant reduction in VAS from 8.1 to 2.65 at 3-month follow-up, indicating a 67% reduction in overall pain.…”

“…Furthermore, since MIST 1.0 there are new decompressive devices that allow for fusion. One has limited data as a stand-alone device in the presence of degenerative disc disease, 107 which represents a minimally invasive open approach, and the other represents a lateral percutaneous approach with no published safety or efficacy data yet. Therefore, for the purposes of this algorithm, only the posterior approach is identified.…”

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study

“…1). It has been previously defined by Falowski et al in a retrospective study demonstrating safety and efficacy [11]. Of note, prior to the procedure, all patients Fig.…”

Knowledge Dissemination in Pain Medicine: Searching for Signal Within the Noise

“…While the use of traditional single shot injections is common practice amongst all pain physicians, several minimally invasive therapeutic options are becoming mainstream as a result of meaningful real-world evidence regarding their use and the dissemination of such using conventional and social media platforms. Dorsal root ganglion stimulation, 1 , 2 minimally invasive lumbar decompression, 3 peripheral nerve stimulation, 4 , 5 minimally invasive sacroiliac joint fusion, 6 , 7 and interspinous spacers 8 are a select few of many innovative minimally invasive options with growing evidence-bases for effectiveness and safety. The father of the group, spinal cord stimulation, which has perhaps the most robust evidence for effectiveness and safety, has also gained additional traction with new modes of stimulation, smaller generator sizes, and an expansion of US Food and Drug Administration (FDA) approved indications.…”