Pacific Research Institute
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.
INTRODUCTION This study will evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in single-level fusion in patients with chronic low back pain that present with degenerative disc disease (DDD) with concurrent neurogenic claudication. Devices included in study are the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material. The device is a bilateral locking plate system which attaches to the spinous processes of the posterior noncervical spine (T1-S1) from an interlaminar approach. The implants have supe…
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.…
The intended study population are adults 18 years or older with symptomatic lumbar degenerative disc disease resulting in back pain with lower extremity symptoms and neurogenic claudication that improves with spinal flexion who are candidates for use of the Zip™ MIS Interspinous Fusion device when undergoing spinal fixation procedures.