Patient Data Collection
We conducted a retrospective review of prospectively collected data from 1st July 2017 to 30th June 2020, using STROBE guidelines for reporting. All consecutive patients aged 18 or older undergoing spinal instrumentation of the thoracic and lumbo-sacral spine using the Mazor X robotic system were included. This current iteration has several software and hardware improvements compared to its predecessors and made the current product more efficient, accurate and user friendly. It was acquired by our institution in 2017 for the above-mentioned strengths and all cases were performed using this robotic system by the senior author (A.V.) during the specified study period. There were no exclusions. Residents and fellows participated frequently in the surgical procedures, under the senior author’s supervision.
Data was collected from our institution’s electronic health records. Demographic characteristics, clinical variables and operative details were captured.
Robot Assisted Surgery Technique
The Mazor X robotic system is a shared control system that allows the surgeon to plan hardware placement and provides stereotactic navigation-based support during the procedure. It does so by positioning and locking the robotic arm along a predetermined trajectory based on 3D-imaging, reducing the degrees of freedom of movement and thus minimizing error. [3, 11] Descriptions of how the system is used for preoperative planning, intraoperative guidance, and screw placement have been outlined in the literature and we employ a similar workflow. [3, 13, 15]
(Peri-)operative Workflow and Patient Management
Pre-operative standing scoliosis x-rays of the spine including flexion and extension films and a 1mm thin cut CT scan are obtained for patients who are undergoing spinal fusion.
In the operating room, patients are positioned prone on a Jackson table. The robotic system is then fixated securely onto the rail on the caudal end of the operating room table. Standard skin preparation and draping are completed, after which, the robotic system is mounted to the posterior superior iliac spine by inserting a single Schanz pin. We then register the robotic system using intra-operative fluoroscopy and merge it with the pre-operative CT scan to obtain accurate navigation as shown in Figure-1. The screw length, diameter, and positioning are all planned by the surgeon on robotic system using the pre-operative CT scan prior to the surgery, similar to standard practice.
Prior to inserting and utilizing navigation tools, accuracy of the navigated tools is ensured by touching known anatomy. The robot is then sent to the first pedicle that is planned to be instrumented. After making skin incision, a fascial knife is inserted through the robotic system, that terminates on the bony surface entry point as shown in Figure-2. A minimally invasive dilator is placed under navigation to identify the planned pedicle screw entry point. Following this, a drill guide and a skive prevention pin tool are both inserted and tamped into place. The center pin is removed and using a Medtronic drill through the same channel, the pedicle is cannulated to the planned depth. A tap is then placed through the working channel and the pedicle is tapped via navigation. The final step is the placement of the screw through the same working channel as shown in Figure-3. Neuro-monitoring and stimulation of screws with electrode probe is used to confirm that all the screws stimulate above the threshold of 12 mA and there is no concern for breach outside the planned trans-pedicular trajectory. Antero-posterior (AP) and lateral fluoroscopy images were then taken to confirm appropriate placement of the instrumentation followed by insertion of a percutaneous rods, final tightening, and removal of the towers. In open procedures, the robot is brought in after exposure of the bony anatomy and trans-pedicular instrumentation follows the steps described above.
Routine post-operative CT scans to assess instrumentation were not obtained to reduce radiation exposure to the patient. 3D-imaging such as CT and/or MRI scans are obtained in the event of new post-operative neurological deficit, radicular pain or hardware abnormality identified on x-rays. The authors believe that using this method, minor screw breaches which are asymptomatic may not have been detected, but remain clinically irrelevant.
Determining Screw Placement Time and Success
The duration of each screw placement was measured from the time of cutting fascia using the fascial knife to time when the screw was in its final position. The Operating Room nurse recorded the times which were then confirmed using the internal clock of the robotic system. The time required for case preparation, registration and closure was excluded since the timing for those portions can be highly variable. Screw placement was assessed by the primary neurosurgeon with fellowship training in spinal surgery. This was determined by the surgeon’s clinical judgement, triggered EMG, intraoperative fluoroscopy images, and post-operative radiographs, similar to methods described in previous literature. [2, 7] Screw placement was then validated by an independent spinal neurosurgeon using post-operative x-ray images. Each screw was classified as follows: [2]
- Grade 1: accurate placement using robot guidance
- Grade 2: screw mispositioned/revised using robot guidance
- Grade 3: manually placed after robotic guidance aborted
- Grade 4: planned screw not placed as deemed non-essential to construct stability
Data Analysis
Frequencies and percentages were reported for nominal data, while mean and standard deviation was calculated for age and BMI of the study participants. To analyze the learning curve, data on the average time of screw placement per case was graphically illustrated. Wilcoxon Rank test was then used to compare time taken to place each screw during the first 20 cases and the cases thereafter. Statistical analysis was performed using IBM SPSS Statistics version 25.0.
Ethical Considerations
This study included analysis of de-identified patient data, and thus approval was obtained from the Institutional Review Board at our institution prior to commencement.