Abstract

Current minimally invasive spine procedures are technically challenging and may result in protracted operative time compared to open approach procedures. The guide wireless pedicle screw system (GPSS), was developed to eliminate lengthy steps and potential risks associated with Jamshidi needles and K-wire insertion. The primary objective of this study was to compare screw insertion time in the GPSS with the current standard of care. This case study was conducted between July 2016 through May 2017. 29 patients with degenerative spinal pathologies underwent MIS TLIF or XLIF procedures with GPSS(n=15) vs. a standard MIS system (n=14). The primary outcome measure was the time taken for the screw to be inserted into the pedicle (preparation/tap/screw; PTS). Student’s t-tests were used to compare mean outcome measures between control and GPSS cases. Patient age ranged from 30-70+ years old. Overall, results demonstrated a 47% decrease (p<0.001) in mean time for PTS in the GPSS arm when compared to the control. No significant differences were seen between the two arms when analyzing mean total fluoroscopy time and total procedural time (p>0.05). In the TLIF subgroup analysis, mean total procedure time, PTS and fluoroscopy time decreased for the GPSS arm compared to control (1%, 46% and 10% respectively), however none were statistically significant. In the XLIF subgroup analysis, total mean procedure and PTS time decreased for the GPSS arm compared to control by 14% (p=0.34) and 48% (p=0.006) respectively. A 33% (p=0.46) increase in total fluoroscopy time was also noted in this subgroup. These initial findings demonstrate that GPSS has the potential to significantly decrease time for PTS when compared to compared to a standard MIS system. Additionally, while not statistically significant, GPSS demonstrated the potential to reduce total fluoroscopy time using a TLIF approach.

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