Novel MIS 3D NAV Single Step Pedicle Screw System (SSPSS): Workflow, Accuracy and Initial Clinical Experience

Area of Science:

• Spine Surgery
• Minimally Invasive Surgery
• Orthopedic Technology

Background:

• Minimally invasive spine surgery (MIS) requires precise pedicle screw placement.
• Traditional MIS techniques can be complex and time-consuming.

Purpose of the Study:

• To evaluate the safety, workflow, and initial clinical experience of a novel single step pedicle screw system (SSPSS) for MIS.
• To assess the accuracy and efficiency of the SSPSS in pedicle screw fixation.

Main Methods:

• A prospective case series involving 24 patients undergoing pedicle screw fixation using the SSPSS.
• Intraoperative CT scans were used to evaluate pedicle wall penetration, graded by severity and location.
• Accuracy was determined by the absence of breaches (Grade 0).

Main Results:

• The study included 135 screws, with a median insertion time of 2.45 minutes per screw.
• Pedicle wall penetration occurred in 10% of screws (14/135), with 7% classified as Grade 2 breaches.
• The overall accuracy rate was 90%, with no revision surgeries or complications reported.

Conclusions:

• The SSPSS is a safe, accurate, and efficient tool for MIS pedicle screw fixation.
• The accuracy achieved with SSPSS is comparable to existing literature for MIS techniques.
• The system streamlines the workflow by eliminating K-wires and multiple traditional steps.