Aurora Spine Corporation announced it has received Institutional Review Board approval for its new multicenter 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 stabilize 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 United States 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.

The primary outcomes of interest for this study will be fusion assessment with patient follow-up visits at 3 months, 6 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 (NDI and VAS) will be collected at follow up visits and assessed compared to baseline.