Aurora Spine received Institutional Review Board (IRB) multi-site selection approval for its new multicenter study of the DEXA-C Cervical Interbody System. The study has selected seven sites with three submitted for approval. After approval, patient enrollment is expected to begin. The study will initially include data from 40 single-level and 40 multi-level subjects.
Based on the DEXA T-score for measuring a patient’s bone density, the DEXA technology platform includes implants of varying densities to match a patient’s bone density. The system implants an interbody spacer into the cervical intervertebral body space to stabilize and fuse the level. Allograft will be used in the spacer, and the spinal segment is fixed with an anterior cervical plate.
The primary outcomes of interest for this study will be fusion assessment with patient follow-up visits at three, six, 12 and 24 months post-surgery. Included in the data collection will be fusion assessment from Static and Dynamic X-Ray 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 will be collected at follow-up visits and assessed compared to baseline.
Aurora Spine received Institutional Review Board (IRB) multi-site selection approval for its new multicenter study of the DEXA-C Cervical Interbody System. The study has selected seven sites with three submitted for approval. After approval, patient enrollment is expected to begin. The study will initially include data from 40 single-level and 40...
Aurora Spine received Institutional Review Board (IRB) multi-site selection approval for its new multicenter study of the DEXA-C Cervical Interbody System. The study has selected seven sites with three submitted for approval. After approval, patient enrollment is expected to begin. The study will initially include data from 40 single-level and 40 multi-level subjects.
Based on the DEXA T-score for measuring a patient’s bone density, the DEXA technology platform includes implants of varying densities to match a patient’s bone density. The system implants an interbody spacer into the cervical intervertebral body space to stabilize and fuse the level. Allograft will be used in the spacer, and the spinal segment is fixed with an anterior cervical plate.
The primary outcomes of interest for this study will be fusion assessment with patient follow-up visits at three, six, 12 and 24 months post-surgery. Included in the data collection will be fusion assessment from Static and Dynamic X-Ray 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 will be collected at follow-up visits and assessed compared to baseline.
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