OBJECTIVES Minimally invasive surgical (MIS) approaches in spinal surgery are considered to have less perioperative blood loss and shorter duration of hospitalization compared to open procedures. However, steeper learning curves, higher technical demand, longer operating times and fluoroscopy exposure are common challenges. The VIPER PRIME™ System was designed to mitigate these challenges by introducing the first pedicle screw placement system with a screw tip design and stylet that obviates the need for pedicle preparation. This study assesses the potential improvements in MIS lumbar spine procedural efficiency comparing the VIPER PRIME System to conventional MIS techniques using Jamshidi/guidewires.

METHODS : A prospective procedural efficiency study was conducted between 2016 and 2019. 50 patients with degenerative spinal pathologies were enrolled in this study. Two surgeons performed MIS Transforaminal or Lateral Lumbar Interbody Fusion procedures with the VIPER®2 MIS Spine System using Jamshidi/guidewires (control group) and the VIPER PRIME System (experimental group). The primary outcome measure was pedicle screw placement time. Secondary outcome measures included total procedure time and total fluoroscopic exposure. Subgroup analysis was conducted utilizing surgical approach and segmental levels.

RESULTS Patients were most commonly over the age of 50 (highest frequency: ages 60-64 (24%) in control group; ages >70 (24%)) in experimental group. The VIPER PRIME™ System was shown to significantly reduce pedicle screw placement time by 49% and 48% utilizing the transforaminal approach (p=0.0001) and the lateral approach (p=0.002), respectively. There was also a decrease of 43% and 67% in one-level procedures (p=0.00002) and two-level procedures (p=0.005), respectively. No significant differences were observed in secondary outcome measures.

CONCLUSIONS This study demonstrates the value of the VIPER PRIME™ System in a clinical setting, and indicates it has the potential to lower operative time for pedicle screw placement.