P30. Safe and improved spinal surgery using a new device in multiple indications

• Published in: The spine journal 2020-09, Vol.20 (9), p.S160-S161
• Main Authors: Peloza, John H., Millgram, Michael, Khoo, Larry T., Malone, Hani, Guyer, Richard D., Huec, Jean-Charles Le, Ashkenazi, Ely
• Format: Article
• Language: English
• ISSN: 1529-9430; 1878-1632
• DOI: 10.1016/j.spinee.2020.05.428

Spinal procedures often require the removal of bony tissues to prevent nerve compression and reduce pain. In order to reach difficult-access spinal regions such as the foramen, the surgeon is often required to drill (or otherwise remove) through healthy supporting bone structures, therefore increasing the risk of spinal instability. This study describes the authors' experience with a recently developed, FDA-approved, curved-at-the-tip drill-like device, designed to provide efficient bone removal from difficult-access areas. The device is shielded on one side of the tip in order to improve safety and reduce the risk of complications. Multi-center retrospective study and surgeon questionnaire analysis. Device-use patterns were extracted from 103 lumbar foraminotomies, 53 cervical osteophyte removals and 143 transforaminal lumbar interbody fusion (TLIF) procedures conducted using the device and 66 comparable control TLIF procedures conducted by the same surgeon group used as a control group. Device-related dural tear rate, surgeon assessment of the procedure, duration of device use. For the TLIF procedures, OR time and length of stay were also compared with the control group. The rate of device-related dural tears was calculated from 1,116 safety records of procedures conducted using the device and compared with literature rates of traditional-tools device-related tears. Surgeon assessment was obtained using questionnaires at the end of each procedure. The duration of device-use, length of procedure and other operative and postoperative parameters were extracted from procedure records and reviewed where available. The device-related dural tear rate was 0.3% (three tears in 1,116 procedures). This rate is significantly lower than the device-related tear rate of 2.9% associated with the Kerrison rongeur and high-speed drill published in a prior literature review. Surgeon satisfaction rate was 94% and sufficient bone volume reduction was reported in 95% of the procedures. Surgery time reduction was the most common comment in surgeon questionnaires. In some cases, of multi-level complicated fusions, the time reduction was estimated as several hours. Lumbar foraminotomy using the device required, on average, 2 minutes/foramen. In some of the cases, the device enabled the surgeon to avoid a spinal fusion as the improved access eliminated the need for excessive bone removal. Cervical osteophyte removal required, on average, three minutes, and in the majority of the