Aurora Spine Corporation, a designer and manufacturer of medical devices that improve spinal surgery outcomes, is proud to announce that its DEXA-C Cervical Interbody System has received Institutional Review Board (IRB) approval for a new multicenter study. This system is designed to treat skeletally mature patients suffering from degenerative disc disease (DDD) of the cervical spine, with accompanying radicular symptoms at one or two contiguous levels from C2-T1. With this approval, Aurora Spine is taking a major step forward in its mission to improve spinal surgery outcomes.
Aurora’s revolutionary DEXA-C system is transforming the way anterior cervical discectomy and fusion surgery is performed. Featuring a patented DEXA technology platform, the DEXA-C system uses color-coded implants with varying densities to match the patient’s bone density and DEXA T-Score. Allograft is then used in the interbody spacer, which is implanted into the cervical intervertebral body space(s). Finally, the spinal segment(s) are stabilized with an anterior cervical plate for a successful procedure. With DEXA-C, spine surgeons now have a powerful tool to help them treat their patients with the utmost precision.
The DEXA-C study is coming to up to 10 investigative sites across the United States, with the goal of collecting data from 80 subjects – 40 single level and 40 multiple level. We anticipate that the study will provide invaluable insights into the efficacy of this new technology.
Mr. Trent Northcutt, Aurora’s President, CEO and co-founder, is thrilled with the initial success of their DEXA-C series of implants. After entering the beta-testing phase, the response has been overwhelmingly positive. As they work to expand their DEXA franchise, they are grateful to the doctors and patients who have taken part in this study and are eager to review their results in the future.
At the UC Irvine Spine Center, our surgeons are thrilled to be part of a study that may help address some of the difficulties associated with anterior cervical surgery, such as subsidence and nonunion. According to Dr. Nitin N. Bhatia, Chairman of Orthopaedic Surgery and Professor of Orthopaedic Surgery and Neurosurgery, as well as Chief of the Spine Service at UC Irvine, cervical interbody implants that are tailored to a patient’s bone density could provide a powerful solution.
Dr. Steven Falowski, a Functional Neurosurgeon in Lancaster, PA, is thrilled with the introduction of Dexa-C technology to the spinal fusion market. By taking into account a patient’s bone density and quality during the fusion process, this cutting-edge technology is set to revolutionize patient outcomes. Aurora is leading the charge in innovating and producing clinical data to back up the use of this groundbreaking product.
Sebastian Koga, MD, FAANS, a neurosurgeon with Forrest Health Institute of Neurosciece and Director of Koga Neurosurgery in Covington, Louisiana, is excited about the latest advancement in biomaterials innovation: DEXA. This innovative implant has the potential to revolutionize personalized spine medicine and orthopedic implants. Already, Dr. Koga has used the DEXA implants in nearly 200 cases, and he believes that any spine surgeon treating patients with osteoporosis will understand the great advantage of this new material. With its potential to expand beyond spinal procedures to other bone and dental implants, DEXA is sure to make a lasting impact in the medical field.
This study will track patient progress post-surgery, focusing on fusion assessment at 3, 6, and 12 months. X-Ray imaging (AP/LAT/Flex/Ex) will be used to measure bridging bone, lucencies at the graft-vertebral body junction, and motion. By ensuring fusion criteria such as no lucencies and motion of less than 1mm, this study will provide valuable information on successful spinal fusion surgeries.
Patients’ progress will be measured through more than just subsidence and alignment assessments – we will also track their progress through patient reported outcomes such as NDI and VAS scores, collected at follow-up visits and compared to baseline.
About Aurora Spine
Aurora Spine is revolutionizing the spinal implant market with cutting-edge, minimally invasive, regenerative technologies. We are committed to providing innovative solutions that improve the quality of life for those suffering from spinal issues.
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