REFINE Study: A Prospective, Observational, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.
• Subjects enrolled in this study must meet ALL of the following inclusion criteria:
‣ Subject must provide written informed consent prior to any clinical study-related procedure.
⁃ Subject is at least 18 years or older at the time of enrollment, skeletal mature.
⁃ Subject has 1-2 symptomatic lumbar degenerative disease at adjacent level, T12-S1, with or without grade I spondylolisthesis (confirmed by history and radiographic studies).
⁃ MRI within 12 months prior to the procedure with at least mild to moderate spinal stenosis at the index treatment level
⁃ Subject has undergone at least 3 months of non-operative treatment.
⁃ Subject presents with ZCQ physical function ≥ 2.0 at baseline.
⁃ Subject reports relief from lumbar flexion and/or sitting.
⁃ Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm.