Robotic-guided placement of cervical pedicle screws: feasibility and accuracy.

INTRODUCTION: It has been shown that pedicle screw instrumentation in the cervical spine has superior biomechanical pullout strength and stability. However, due to the complex and variable anatomy of the cervical pedicles and the risk of catastrophic complications, cervical pedicle screw placement is not widely utilized. STUDY DESIGN: A retrospective, consecutive patient review. OBJECTIVE: To review and report our experience with robotic guided cervical pedicle screw placement. METHODS: We retrospectively reviewed preoperative and postoperative CT scans of 12 consecutive patients who underwent cervical pedicle screw fixation with robotic guidance. Screw placement and deviation from the preoperative plan were assessed using the robotic system's planning software by fusing the preoperative CT (with the planned cervical pedicle screws) to the post-op CT. This process was carried out by manually aligning the anatomical landmarks on the two CTs. Once a satisfactory fusion was achieved, the software's measurement tool was used manually to compare the planned vs. actual screw placements in the axial, sagittal and coronal planes within the instrumented pedicle in a resolution of 0.1 mm. Medical charts were reviewed for technical issues and intra-operative complications. RESULTS: Eighty-eight cervical pedicle screws were reviewed in 12 patients; mean age = 65 years, M:F = 2:1, and mean BMI = 27.99. No intra-operative complications related to the cervical pedicle screw placement were reported. Robotic guidance was successful in all 88 screws: eight in C2, 14 in C3, 16 in each of C4 and C5, 19 in C6, and 15 at C7. There were 14 pedicle screw breaches (15.9%); all were medial, less than 1 mm, and with no clinical consequences. In the axial plane, the screws deviated from the preoperative plan by 1.32 ± 1.17 mm and in the sagittal plane by 1.27 ± 1.00 mm. In the trajectory view, the overall deviation was 2.20 ± 1.17 mm. Although differences were observed in screw deviation from the pre-op plan between the right and left sides, they were not statistically significant (p > 0.05). CONCLUSION: This study indicates that robotic-guided cervical pedicle screw placement is feasible and safe. The medial breaches did not result in any clinical consequences.

The predictive accuracy of surgical planning using pre-op planning software and a robotic guidance system.

BACKGROUND: Navigation and robotic-guided systems are being used more often to facilitate efficient and accurate placement of hardware during spinal surgeries. Preoperative surgical planning is a key step in the safe use of these tools. No studies have yet investigated the predictive accuracy of surgical planning using a robotic guidance system. METHODS: Data were prospectively collected from patients in whom Mazor X-Align ™ [Medtronic Inc., Minneapolis, MN., USA] robotic guidance system software was used to plan their spinal instrumentation in order to achieve the best possible correction and the plans executed intraoperatively under robotic guidance. RESULTS: A total of 33 patients (26 females, 7 males) were included. Their mean age was 51 years (12-79), and their mean BMI was 23.90 (15.55-35.91). Their primary diagnoses were scoliosis (20), kyphosis (5), spondylolisthesis (4), adjacent segment degeneration (3), and metastatic tumor (1). Preoperatively, the patients' mean coronal Cobb Angle (CA) was 36.5 ± 14.4°, and their mean sagittal CA was 27.7 ± 20.0°. The mean planned correction coronal CA was 0.2 ± 1.2°, and the mean planned correction sagittal CA was 28.4 ± 16.7°. Postoperatively, the patients' mean coronal CA that was achieved was 5.8 ± 7.4°, and their mean sagittal CA was 31.0 ± 18.3°. The mean difference between the planned and achieved angles was 5.5 ± 7.4° for the coronal, and 9.03 ± 9.01° for the sagittal CA. For the thoracic kyphosis and lumbar lordosis, the mean difference between the planned and postoperatively measured values was 15.3 ± 10.8 and 12.8 ± 9.6, respectively. CONCLUSION: This study indicates that the predictive accuracy of the use of preoperative planning software and robotic guidance to facilitate the surgical plan is within 6° and 9° in the coronal and sagittal planes, respectively.

Robotic-Assisted Pedicle Screw Placement During Spine Surgery.

Preoperative planning software and a robotic device facilitate the placement of pedicle screws, especially in patients with difficult anatomy, thereby increasing the feasibility, accuracy, and efficiency of the procedure. The robot functions as a semiactive surgical assistive device whose goal is not to substitute but to offer the surgeon a set of versatile tools that can broaden his or her ability to treat patients1. DESCRIPTION: The robotic guidance system consists of a bed-mounted surgical arm and a workstation. We used the Mazor X Stealth Edition Robotic Guidance System by Medtronic for spine surgery, which has been previously described2-5. Unlike other systems that are navigation-based and require an optical tracking mechanism, this system relies on the preoperative plan to be referenced using the intraoperative registration. The workstation runs an interface software that facilitates preoperative planning, intraoperative image acquisition and registration, kinematic calculations, and real-time robot motion control. The robotic arm is mounted onto the bed as well as rigidly attached to the patient's spine. It can move in 6 degrees of freedom to provide the preplanned screw trajectory and entry point thereby allowing the surgeon to manually perform the drilling and screw insertion through either an open or percutaneous procedure by first seating a drill tube and then drilling and tapping the hole as needed. ALTERNATIVES: Other robotic systems include the ROSA robot by Medtech, the ExcelsiusGPS robot by Globus Medical, and the SurgiBot and ALF-X Surgical Robotic systems (both from TransEnterix). The Da Vinci Surgical System (Intuitive Surgical) has been utilized for laparoscopic anterior lumbar interbody fusion (ALIF), but it has not been approved by the U.S. Food and Drug Administration for actual spinal instrumentation. Alternative surgical techniques for pedicle screw placement include the freehand fluoroscopy-guided technique and intraoperative image-assisted computer navigation techniques, including isocentric C-arm (Iso-C) 3D (3-dimensional) navigation (Siemens), computed tomography (CT) navigation, O-arm navigation (Medtronic), CT-magnetic resonance imaging co-registration technology, and a 3D-visual guidance technique6-8. RATIONALE: The robotic-guided pedicle screw placement offers the following benefits over conventional dorsal instrumentation techniques: improved accuracy and safety in pedicle screw insertion2-4,9-13; precision in screw size selection and planned screw positioning2; a reduction in exposure to radiation for the surgeon, the patient, and the operating-room staff9,11,12,14-19; simplicity and user-friendliness with a moderate learning curve10,11,20,21; ease of registration and reduction of operating time2; significant enhancement of the surgeon's ergonomics and dexterity for repetitive tasks in pedicle screw placement15,22-24; and a wider coverage in function to include utilization during minimally invasive surgery where applicable11,25. EXPECTED OUTCOMES: Accuracy rates between 94.5% and 99%, comparable with those in our study10, have been reported with the robotic-guided pedicle screw insertion technique, even in studies involving complex deformities and revision surgeries for congenital malformations, degenerative disorders, destructive tumors, and trauma2-4,9-13. The safety of this technique, in terms of reduced complications and intraoperative radiation exposure, has also been documented as higher than that for freehand fluoroscopic guidance or other navigation techniques9,11,12,14-19. The feasibility of this procedure has been further extended to minimally invasive procedures and to use in the cervical region, with replication of its advantages. It is associated with a reasonable learning curve, with consistent successful results after 25 to 30 patients. IMPORTANT TIPS: The principles of robotic-guided pedicle screw placement are similar irrespective of the system used.Although initially utilized mainly for thoracolumbar pedicle screw insertion, the latest robots and software have been adapted for use in the cervical spine with equivalent efficiency and accuracy.Robotic guidance can be employed in non-pedicle-screw-insertion procedures.Challenges include radiation exposure, trajectory failure, equipment and software failure, failed registration, logistics, time, and high cost.