REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subjects enrolled in this study must meet ALL of the following inclusion criteria: 1. Subject must provide written informed consent prior to any clinical study-related procedure. 2. Subject is at least 18 years or older at the time of enrollment, skeletal mature. 3. 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). 4. MRI within 12 months prior to the procedure with at least mild to moderate spinal stenosis at the index treatment level 5. Subject has undergone at least 3 months of non-operative treatment. 6. Subject presents with ZCQ physical function ≥ 2.0 at baseline. 7. Subject reports relief from lumbar flexion and/or sitting. 8. Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm. Exclusion Criteria: * Subjects enrolled in this study must NOT meet any of the following exclusion criteria: 1. Subject is unable to pr