Improved Bone-Removal Using a New Device in Open and Minimal Invasive Approaches: A 2-Center Experience With 143 Patients
Presented at SMISS Annual Forum 2019
By John Peloza MD
With Larry Khoo MD, Michael Millgram MD, Scott Kutz MD, Richard Guyer MD, Ely Ashkenazi MD,
Disclosures: John Peloza MD None Larry Khoo MD B; Carevature Medical Ltd., Michael Millgram MD B; Carevature Medical Ltd., Scott Kutz MD B; Carevature Medical Ltd., Richard Guyer MD B; Carevature Medical Ltd., Ely Ashkenazi MD B; Carevature Medical Ltd.. D; Carevature Medical Ltd.,
Spinal procedures often require the removal of bony tissues to prevent nerve compression and reduce pain. Sufficient bone removal is complicated by the need to minimize supporting bony structure destruction. Efficient osteophyte removal can prevent future pain and discomfort and may therefore be necessary in some cases. Traditional bone removal tools and methods limit the surgeon’s ability to reach difficult to access regions and therefore increase healthy bone removal and procedure time.
Here we describe and evaluate the experience accumulated using a recently developed, FDA-approved, shielded curved drill, designed to provide efficient bone removal from difficult to access bony structures such as the foramen, while improving procedure safety and speed.
The device was used in 2 centers to perform foraminotomy, osteophyte removal, and disc-space preparation since October 2016. All the procedures for which a record of device use was available were included in the analysis. Overall, 143 procedures were reviewed, including lumbar and cervical spinal fusions and decompressions. Of these 143 procedures, 77 were performed minimally-invasively. Procedure length of time was recorded, as well as the duration of device use. Surgeon assessment was obtained using questionnaires at the end of each procedure.
All the procedures were deemed successful, without device-related tears. Sufficient bone removal was obtained using the device in 96% of the procedures. In some cases of multi-level complicated fusions, the time reduction using the device was estimated at several hours. Lumbar foraminotomy using the device required, on average, 2 minutes/foramen. Osteophyte removal required, on average, 3.2 minutes. The device was successfully used in both open and minimal invasive settings.
The results of the study found that the device is safe and effective for performing osteophyte removal and foraminotomy in both open and minimal invasive settings. Procedure time reduction was noted as the most significant advantage by the surgeons.