REFINE Study Evaluating Aurora Spine ZIP MIS Interspinous Fusion System for Chronic Low Back Pain with Degenerative Disc Disease and Neurogenic Claudication

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the Aurora Spine ZIP MIS Interspinous Fusion System combined with bone graft material in adults with chronic low back pain caused by degenerative disc disease and neurogenic claudication. This condition involves deterioration in the spine that can cause pain and difficulty walking. The study aims to provide insight into this device as a treatment option compared to existing therapies. The study uses the Aurora Spine ZIP device, a bilateral locking plate system that attaches to the spinous processes in the lower spine from T1 to S1 through a minimally invasive interlaminar approach. The device includes articulations and a central chamber for bone graft material to support fusion at a single spinal level. Participants have already tried at least three months of non-operative treatments before receiving this implant. During the study, participants will be monitored for improvements in pain and function at 3 and 12 months after the procedure. Researchers will collect data on pain relief using the Visual Analog Scale VAS, physical function scores, patient global impression of change, imaging outcomes, and complication rates. The study involves multiple centers and follows participants over time to assess real-world effectiveness and safety of this fusion device.

REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain