Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
brief summary
The goal of this clinical trial is to assess the safety and effectiveness of the study device, CORUS-LX, as an adjunct to lumbar interbody fusion, when used in combination with pedicle screw and rod constructs for the treatment of lumbosacral degenerative disease in patients requiring 2 level (L4-S1) lumbar fusion, for the treatment of symptomatic degenerative lumbosacral disc disease. The main questions it aims to answer are: Is there fusion success at the treated posterior anatomy of each level? Is there an absence of major adverse device related events? Is there an absence of injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain? Researchers will compare a control arm to the treatment arm to see if research results vary from standard minimally invasive supplemental posterior fusion. Eligible participants will undergo one of the below interventions: * Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the study device, including pedicle screw and rod fixation. * Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation. Participants will also be asked to read, understand, and sign the informed consent, attend a Screening/Baseline visit, undergo surgery for their designated intervention, and participate in 5 additional study visits where they will complete surveys for patient reported outcomes and SOC procedures. These visits will occur at the below intervals (based upon surgery day as day 0): * 6 weeks * 3 months * 6 months * 12 months * 24 months
detailed description
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.
official title
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes for the Treatment of Degenerative Lumbosacral Disc Disease.