Aurora Spine Corporation announced the publication of the first 6-month clinical evaluation of its ZIP?? fusion implant in the Journal of Pain Research. Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis.

Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study is to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success. The scientific paper titled "Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous fixation Device: REFINE Study 6-month Results", is a pivotal multi-center study of its ZIP??

InterspinousFixation device for patients suffering from back pain due to symptomatic degenerative disc disease and spinal stenosis. The REFINE Screwless?? ZIP Study utilized patient evaluations at 3- and 6-months following treatment and is part of an actively enrolling, institutional review board (IRB) approved, single-arm, multicenter, prospective, open-label 12-month study.

Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index (ODI), Visual Analog Scale (VAS) of the back and leg pain during walking and standing, andurich Claudication Questionnaire (ZCQ), and secondarily using the Patient Global Impression of Change (PGIC) and Patient-Reported Outcomes Measurement Information System (PROMIS). This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device. Once in place, the device acts as a fusion support column to open the passageways that contain the spinal cord and nerve roots.

This procedure may reduce the compression on the nerves, resulting in potential pain relief in the leg, groin, and buttocks, and then return to a more active lifestyle.