Aurora Spine has announced that it has received Institutional Review Board (IRB) approval for its new multicentre study of its DEXA-C cervical interbody system, which is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2–T1.
The DEXA-C system is the first product on the market using Aurora’s patented DEXA technology platform, which creates a series of implants that are color-coded and manufactured with varying densities in order to match with a patient’s bone density and DEXA T-Score.
DEXA-C is intended for use on patients who require anterior cervical discectomy and fusion surgery. The system implants an interbody spacer(s) into the cervical intervertebral body space(s) to stabilise and fuse the level(s). Allograft will be used in the spacer and the spinal segment(s) are fixed with an anterior cervical plate.
The DEXA-C study will be conducted at up to 10 investigative sites in the USA and it is anticipated that data from at least 40 single level subjects and at least 40 multiple level subjects will be entered into the study.
Trent Northcutt, Aurora’s president, CEO and co-founder, said: “Aurora has been in the beta-testing phase with our DEXA-C series of implants and initial response has been very positive. As we build out our DEXA franchise, the clinical data around DEXA-C usage will help us advance this product and future DEXA products. We appreciate the doctors and patients participating in this study and look forward to receiving and reviewing their outcomes in the future.”
Nitin Bhatia, chairman of orthopaedic surgery at the University of California (Irvine, USA), added “Cervical interbody implants matched to a patient’s underlying bone density may help solve some of the challenges in anterior cervical surgery including subsidence and non-union. Our surgeons at the UC Irvine Spine Center are excited to be part of this study.”
The primary outcome measures for the study will be fusion assessment, with patient follow-up visits at three months, six months and 12 months post-surgery. Included in the data collection will be fusion assessment from Static and Dynamic X-Ray (AP/LAT/Flex/Ex) using the following criteria: bridging bone inside or outside of graft; no lucencies at the graft-vertebral body junction; and motion <1mm.
The secondary outcome measures will include subsidence and alignment assessments. Patient reported outcomes (neck disability index and visual analogue scores) will be collected at follow-up visits and assessed compared to baseline.
Steven Falowski, a functional neurosurgeon (Lancaster, USA), commented: “The DEXA-C technology marks a milestone in the development of spinal fusion products to not only help ensure, but also further improve great patient outcomes. A patient’s bone density and quality is a very well-known factor in fusion results and patient outcomes. Aurora has also shown its dedication to not only bringing these innovative landmark products to market, but also ensuring the production of strong clinical data to support their use.”
Sebastian Koga, a neurosurgeon with Forrest Health Institute of Neuroscience, and director of Koga Neurosurgery (Covington, USA), stated: “DEXA is a huge step in biomaterials innovation, and the first step in personalised spine medicine. Like all great inventions it is an elegant and simple concept. Aurora Spine has demonstrated that artificial implants can match and mimic human biology.
“I have used DEXA implants in nearly 200 cases already and I cannot imagine going back to a conventional cage. Any spine surgeon operating on patients with osteoporosis will understand the great advantage of this new material. I can also envision this new material expanding from spinal procedures to other bone implants and dental implants, and further advancing to replace most orthopaedic implants.”