Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care

Trial design

• Allocation: Randomized
• Interventional Model: Parallel Assignment (double armed)
• Interventional Model Description: Dual center, prospective, randomized cohort study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Enrolment: 32 (thirty-two) patients - 16 (sixteen) patients experimental and 16 control arms (100 screws each arm, estimated 20% of patients drop out).

Study arms

• Experimental arm: PathKeeper System (PKS) One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.

Interventions: Medical Devise - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels.

• Control arm: free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy.

Interventions: Pedicle screws will be placed using the free-hand technique with 2D fluoroscopy as the intraoperative imaging modality.

Primary endpoints:

Evaluate and classify the pedicle screw positions as per the Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan, in each study arm and comparatively.

Number of misaligned screws as per the Gertzbein-Robbins classification scale (Gertzbein and Robbins, 1990) class E screws class D screws class C screws class B screws class A screws

Secondary endpoints:

• Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.
• Evaluate time-per-screw for the experimental device arm (PKS) arm.
• Length of stay - (non-critical)
• Estimated blood loss (EBL) - (non-critical)
• Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized

Inclusion criteria

• Men and women
• 16 and above years old
• Patients who are about to undergo open, instrumented spinal surgery
• Signed informed consent form

Exclusion criteria

• Men and women
• 16 and above years old
• Patients who are about to undergo open, instrumented spinal surgery
• Signed informed consent form