Aurora Spine has received multi-site selection approval from Institutional Review Board (IRB) for its new trial of the DEXA-C Cervical Interbody System.
The multi-centre trial has selected seven centres and three have been submitted for approval. Subject enrolment for the trial is expected to commence on securing approval.
The trial will initially include results obtained from 40 single-level and 40 multiple-level patients.
The primary outcomes of interest for this trial will be fusion evaluation with patient follow-up visits at three, six, 12 and 24 months after surgery.
The data collection will feature fusion assessment from Static and Dynamic X-Ray (AP/LAT/Flex/Ex) using the bridging bone inside or outside of graft; no lucencies at the graft-vertebral body junction; and motion < 1mm criteria.
Subsidence and alignment assessments will be included as the secondary outcome measures in the trial.
At follow-up visits, the trial will collect patient-reported outcomes (NDI and VAS) and evaluate them against the baseline.
Aurora Spine president, CEO, and co-founder Trent Northcutt said: “We’ll be sure to make periodic updates of this study, with the next steps being the enrollment of patients at these locations.
“The data from this study will be very important to doctors’ thinking about using the DEXA-C series of implants and will help build out our DEXA franchise.”
Indicated for procedures related to anterior cervical interbody fusion, the DEXA-C system is the first in a series of implants based on the patented DEXA technology platform of Aurora.
The system can be used on patients requiring anterior cervical discectomy and fusion surgery and implants an interbody spacer(s) into the cervical intervertebral body space(s) for stabilising the level(s).