Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes

The study device is designed to provide surgeons a tissue-sparing solution for both preparing a fusion bed around the facet space in addition to stabilizing the joint in sync with percutaneous pedicle screw and rod fixation. There have been few rigorous studies looking at the posterior fusion aspect of circumferential lumbar fusion. Through a randomized controlled trial design and multi-modal imaging protocol, we aim to explore whether the opportunity for improved outcomes exists. This randomized controlled trial was designed to compare outcomes in subjects treated with interbody fusion including supplemental posterior fusion for the treatment of degenerative lumbosacral disease. For the control arm subjects, supplemental posterior fusion will be performed with each surgeon's standard protocol for fusion with pedicle screw and rods. Treatment arm subjects will also receive percutaneous pedicle screw fixation but will also have the posterior anatomy prepared for fusion using the study device. In both arms, all posterior instrumentation will be placed using navigation technology. Study success will be defined as the demonstration of statistical superiority by the treatment arm over the control arm with respect to the primary endpoint, which is the incidence of arthrodesis achieved across the posterior anatomy. Additional data of interest will be collected to explore relationships between observed arthrodesis rates at the posterior anatomy and the rates of arthrodesis across the interbody space, serious device-related adverse events, device failure, subsequent surgical revisions, patient-reported outcomes, and return-to-work measures assessed through 24 months. Eligible subjects will be those with degenerative lumbosacral disease diagnosed at 2 levels between the L4 and S1 segments who are indicated for treatment using an interbody fusion approach supplemented with posterior fusion including pedicle screw and rod fixation. Major exclusionary factors will be history of prior instrumentation at the index or adjacent levels, fused facet or facet hypertrophy that prohibits device implantation, and a diagnosis of osteoporosis.