|Year : 2020 | Volume
| Issue : 2 | Page : 48-54
Accuracy and safety of pedicle screws implantation using Zeego and Brainlab navigation system in hybrid operation room
Yew-Weng Fong1, I-Chang Su2, Cheng-Ta Hsieh2, Chih-Ta Huang1, Chih-Ju Chang3
1 Division of Neurosurgery, Department of Surgery, Cathay General Hospital, Taipei City, Taiwan
2 Division of Neurosurgery, Department of Surgery, Cathay General Hospital, Taipei City; Department of Medicine, School of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan
3 Division of Neurosurgery, Department of Surgery, Cathay General Hospital, Taipei City; Department of Medicine, School of Medicine, Fu Jen Catholic University, New Taipei City; Department of Mechanical Engineering, National Central University, Taoyuan County, Taiwan
|Date of Submission||19-Aug-2019|
|Date of Decision||28-Oct-2019|
|Date of Acceptance||07-Jan-2020|
|Date of Web Publication||23-Apr-2020|
Dr. Chih-Ju Chang
Division of Neurosurgery, Department of Surgery, Cathay General Hospital, Taipei City, 280, Secton 4, Jen-Ai Road, Taipei 106
Source of Support: None, Conflict of Interest: None
Background: Hybrid operating room (OR) allows a combination of three-dimensional (3D) robotic fluoroscopy with navigation to be performed intraoperatively for minimally invasive surgery (MIS) of the spine. We aimed to investigate the accuracy and radiation exposure of surgeons and OR staffs when the navigation system is engaged for percutaneous pedicle screws (PPSs) placement.
Materials and Methods: This was a retrospective nonrandomized study involving patients who were all clinically and radiologically compatible with lumbar spondylolisthesis. The Gertzbein and Robbins (G and R) scale was used to define the screw placement accuracy in the navigated group, and the mean numbers of C-arm fluoroscopic images taken for screw positioning verification were recorded. Dichotomous and numerical variables were analyzed with the Chi-square test and t-test, respectively.
Results: Between July 2015 and July 2016, a total of 103 patients were treated, which consisted of 38 patients or 164 PPSs under navigation and 65 patients or 282 PPSs under freehand technique. We found that all navigated PSSs were satisfactorily placed under G and R Grade A and Grade B. The mean fluoroscopic images taken were significantly lower in the navigated two-level and three-level surgeries group. The operation time was longer in navigated two-level surgeries, while there is an insignificant difference in three-level surgeries in both navigated and nonnavigated surgeries.
Conclusion: Intraoperative 3D robotic fluoroscopy with a navigation system for MIS of the spine ensures safe PPS placement and can significantly reduce the radiation exposure of surgeons and medical staffs. The duration of surgeries performed under navigation will improve with a smooth workflow.
Keywords: Accuracy, hybrid operating room, navigation, pedicle screws, safety
|How to cite this article:|
Fong YW, Su IC, Hsieh CT, Huang CT, Chang CJ. Accuracy and safety of pedicle screws implantation using Zeego and Brainlab navigation system in hybrid operation room. Formos J Surg 2020;53:48-54
|How to cite this URL:|
Fong YW, Su IC, Hsieh CT, Huang CT, Chang CJ. Accuracy and safety of pedicle screws implantation using Zeego and Brainlab navigation system in hybrid operation room. Formos J Surg [serial online] 2020 [cited 2020 May 28];53:48-54. Available from: http://www.e-fjs.org/text.asp?2020/53/2/48/283123
| Introduction|| |
Open spinal fixation surgery is a conventional procedure to treat patients with vertebral fracture or spondylolisthesis. The position and orientation of the pedicles are judged by an experienced surgeon using fluoroscopic images. In the past two decades, spinal minimally invasive surgery (MIS) has evolved remarkably. Several approaches to spinal MIS have been developed, including endoscopic, tubular, and percutaneous approaches to achieve spinal decompression and stabilization through the placement of percutaneous transpedicular screws. The advantages of MIS include a smaller operating wound and scar, reduced wound pain, less blood loss, quicker recovery, and a shorter hospital stay.,,,,, However, the pedicle screw insertion performed during MIS is highly dependent on the intraoperative guidance provided by mobile C-arm fluoroscopy radiographs. Numerous fluoroscopic images are needed to confirm the accurate positioning of surgical instruments, and obtaining such a high number of images accounts for the prolonged and high amount of radiation exposure to both surgeons and patients that occurs during such surgeries.,,, As such, intraoperative navigation technologies were developed. These navigation systems have improved patient safety during spinal surgeries by allowing for the precise localization of instrumentation, a benefit which has also made such procedures more efficient. Moreover, a navigation system applied for spinal MIS procedure would reduce the exposure of both surgeons and medical staff members to radiation.,,,,, In short, the innovative technology used in such systems has earned a significant role in the medical industry and continues to develop rapidly.
Hybrid operating rooms (ORs) which incorporate a floor-mounted robotic C-arm with the zeego-BrainLab navigation system offer many possibilities with respect to spinal procedures. In the present study, we report on two aspects of our clinical experiences with integrating the zeego-BrainLab navigation system into lumbar MIS procedures. The results of the study demonstrate the accuracy of the navigation system in localizing the pedicles for screw insertion. In addition, the study also compared a group of lumbar MIS patients who underwent screw insertion with navigation to a group of such patients who underwent screw insertion with a nonnavigated freehand technique in terms of their surgical radiation exposure, or in other words, the radiation that surgeons or medical staff members are exposed to, as indicated by the mean number of C-arm fluoroscopic images taken.
| Methods|| |
This was a retrospective, nonrandomized single-center study of patients who underwent MIS for lumbar fusion with percutaneous pedicle screw (PPS) instrumentation from July 2015 to July 2016. All of the surgeries were performed by an experienced spinal surgeon who had performed approximately 300 minimally invasive lumbar fusion procedures before performing the procedure investigated in this study. The inclusion criteria for spinal fusion were central and/or foraminal stenosis with spondylolisthesis or recurrent disc herniation. This study was approved by the Institutional Review Board of the Cathay General Hospital on June 25, 2012(IRB number CT099036), and written informed consent was obtained from all the patients.
The medical records of all the patients were reviewed, and these records included data on each patient's age, sex, body mass index (BMI), clinical diagnosis, surgical procedures, level of fixation, preparation time for navigation, and the total number of fluoroscopic images taken with the mobile C-arm. The patients were categorized into two groups: the navigated group and the nonnavigated freehand technique group, which are denoted herein as Group 1 and Group 2, respectively. For the Group 1 patients, the screw positions were documented and reviewed under Dyna-computed tomography (CT) and C-arm fluoroscopic images with both anteroposterior and lateral views that were obtained at the end of the operation. The number of mobile C-arm fluoroscopic images taken during the whole instrumentation procedure was recorded. The positions of the screws were evaluated and classified by the Gertzbein and Robbins (G and R) scale into four grades: Grade A (completely within the pedicle), Grade B (pedicle wall breach<2 mm), Grade C (pedicle wall breach = 2–4 mm and no nerve root injury), and Grade D (pedicle wall breach>4 mm)., The Group 2 patients underwent the same operation as the Group 1 patients but without the navigation system, meaning that the screw insertions in their surgeries were guided solely by the mobile C-arm fluoroscopy. Hence, immediate assessment of screws' accuracy intraoperatively could not be performed.
We conducted the surgeries in a hybrid OR using the zeego-BrainLab navigation system with a floor-mounted C-arm cone-beam (CB) CT device (Artis zeego, Siemens). Group 1 consisted of 38 patients, 24 females and 14 males, and these patients received a total of 168 screws. The mean age of the patients was 64.2 ± 9.5 years. Six of the patients received three-level instrumentation, while the other 32 patients received two-level instrumentation surgeries. The majority of the Group 1 patients were diagnosed with L4–5 spondylolisthesis [Table 1]. Meanwhile, the Group 2 patients consisted of 65 patients, 52 females and 13 males, with a mean age was 60.8 ± 11.0 years. Fifty-four of these patients received two-level surgery and 11 received three-level instrumentation surgeries [Table 1].
|Table 1: Summary of the preoperative demographics of the patients in the navigated group and the nonnavigated freehand technique group|
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Hybrid operating room
Initially, we utilized mobile C-arm fluoroscopy to guide the pedicle screw placement. Since the hybrid OR including a floor-mounted robotic C-arm CBCT device (Artis zeego, Siemens Healthcare) and navigation system (BrainLab) was first established in our institution in July 2015, we began performing spinal operations with the assistance of this system whenever the hybrid OR was available for use. In 2008, C-arm-mounted CBCT was introduced as a new imaging modality that used flat-panel detector technology to quickly combine tomographic and fluoroscopic images with a submillimeter spatial resolution for different interventional procedures. Our hybrid OR utilizes a floor-mounted C-arm CBCT device (Artis zeego; Siemens Healthcare) with a 30 cm × 40 cm flat-panel detector, while the BrainLab navigation system utilized the following software: navigation software Spine and Trauma three-dimensional (3D) (BRAINLAB AG, Munich, Germany) and automatic image registration in Angio 3D Spine and Trauma. The system registers 3D data from the intraoperative Siemens Artis zeego 3D rotational angiography scanner with the image-guided system for optimized surgical workflow and provides an optimized user interface that allows intuitive manipulation by surgeons to provide different views, including adjustments in zoom level, dataset positioning, dataset rotation, brightness, and contrast.
Patients were operated on under general anesthesia in a prone position with adequate cushioning to prevent pressure sores. A mobile C-arm fluoroscope was used routinely to locate the level of interest and to identify the pedicles for instrumentation. After making a small midline incision (of around 3 cm in length for two-level lumbar surgery and around 5 cm in length for three-level lumbar surgery), we performed subperiosteal dissection to separate the erector spinal muscles. The affected segment was then exposed as in a traditional microdiscectomy. We used a midline approach to achieve spinal decompression. Standard unilateral laminectomy decompression was then performed at the indicated level. After adequate decompression and decortication of the vertebral body, a cage of appropriate size was introduced into the disc space for interbody fusion. Fixation with pedicle screws following decompression was then completed with or without the navigation system.
Navigation for percutaneous pedicle screws placement
The base of the navigation reference frame was clamped firmly onto the upper or middle level of the spinous process. The camera of the navigation system was directed toward the reference frame for recognition. The surgical instruments to be used in the operation were registered for intraoperative navigation onto the station by placing them on the reference frame. The floor-mounted robotic C-arm was then rotated for 8 s on a 200° circular trajectory from RAO170° to LAO30° around the patient to generate 3D intraoperative images of the lumbar spine. The resulting 3D dataset was then loaded into the software application of the BrainLab navigation system (BRAINLAB AG, Munich, Germany). Real-time intraoperative images in different planes (namely, axial, sagittal, and coronal planes) were generated and digitally reconstructed radiographs (DRRs) were produced. The axial, sagittal, and coronal views are the key points for the planning of the instrumentation trajectory, while the DRRs, which correspond to the real fluoroscopic images taken from C-arm fluoroscopy, provide invaluable information regarding the entry point for each PPS. This step greatly reduces the radiation exposure required to locate the entry point for each PPS guided by C-arm fluoroscopy [Figure 1]. However, if there was incoherency between the DRR images and the mobile C-arm fluoroscopic images, we would dismiss the use of the navigation system. We would proceed with the surgery by a mobile C-arm fluoroscope. After determining the given entry point on the skin, a small stab incision was made, and a dilator was advanced and docked on the outer margin of the facet joint to locate the optimal entry point for the pedicle screw. The navigable tap was used to cannulate the pedicle, and subsequently, a navigable screwdriver was used for the placement of screws under real-time image guidance. We utilized the Dyna-CT, which provides an immediate postprocessed isotropic dataset of C-arm CBCT data, for confirmation of the accurate positioning of the pedicle screws immediately after the operation in the OR [Figure 2].
|Figure 1: Localizing the entry point of pedicle screws. Digitally reconstructed radiograph image generated by the zeego-BrainLab navigation system accurately localize the entry point for L4 pedicle with a navigable tap, shown in green (a). Mobile C-arm fluoroscopic image confirmed the position of navigable tap directed to the L4 pedicle (b)|
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|Figure 2: Evaluation of pedicle screw placement in a case of L4–5 spondylolisthesis. The axial (a) and sagittal (b) views of Dyna-computed tomography images of the lumbar spine obtained intraoperatively showed that all screws were inserted safely without breaching pedicle walls at bilateral pedicles of L4 and L5|
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Group differences in terms of dichotomous and numerical variables were analyzed with the Chi-square test and t-test, respectively. Significance was defined as P < 0.05. Data were analyzed with the commercially available software Number Cruncher Statistical System (NCSS) 2011 (NCSS Inc, Kaysville, UT, USA).
| Results|| |
A total of 164 pedicle screws were placed in 38 patients (14 males and 24 females) with a mean age of 64.2 years (range: 36–80 years) in Group 1. A total of 282 screws were placed in the 65 patients (13 males and 52 females) with a mean age of 60.8 years (range: 31–82 years) in Group 2. In terms of the screw positioning accuracy for Group 1, 158 screws were rated Grade A, six were rated Grade B, and no screws were rated Grade C or Grade D.
In Group 1, the mean numbers of C-arm fluoroscopic images taken were 16.3 ± 14.0 and 21.7 ± 10.8 for the two-level surgeries and three-level surgeries, respectively. In our initial stage of engaging the navigation system for spinal surgery, more fluoroscopic images were taken for accuracy confirmation. In Group 2, the mean numbers of images taken were 79.4 ± 7.3 and 120.6 ± 23.5 for the two-level surgeries and three-level surgeries, respectively. In general, the number of C-arm fluoroscopic images taken for the Group 2 patients, for whom the navigation system was not engaged, was significantly higher than the number for the Group 1 patients (P < 0.001) [Table 2]. More specifically, there was also a significant difference between the two groups in terms of the number of C-arm fluoroscopic images taken for the two-level surgeries [P < 0.001; [Table 2]. The navigated spinal surgeries thus enabled the exact localization of pedicle screw placement with significantly less radiation exposure than the nonnavigated spinal surgeries.
|Table 2: Comparisons of preoperative demographics of the patients in the navigated and the nonnavigated groups|
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In Group 1, the average duration taken for preparation was 13.5 ± 5 min. The average operation time was 130.9 ± 19.3 min for the two-level surgeries and 148.0 ± 54.7 min for the three-level lumbar surgeries. In Group 2, the average operation time was 105.4 ± 35.1 min for the two-level surgeries and 145.9 ± 27.1 min for the three-level surgeries. Even though the Group 1 two-level surgery patients had a longer average operation time than the Group 2 two-level surgery patients, there was no significant difference between the operation times of the two groups for the three-level surgeries. There were also no significant differences in age, sex, and BMI between the two groups.
| Discussion|| |
Lumbar fusion is a common surgical procedure for the treatment of symptomatic spinal pathologies such as degenerative spinal disease, trauma, spondylolisthesis, and deformity. However, in the conventional midline approach, extensive muscle dissection and retraction were necessary to identify the position and orientation of the pedicles. This subsequently caused denervation of the back muscles and resulted in muscle atrophy, which would account for the associated postoperative pain, long recovery time, and impaired spinal function.,,, Since the initial description of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) in 2002, the MI-TLIF procedure has gained significant popularity in the treatment of lumbar degenerative diseases., MIS procedures have several benefits, including smaller scars, reduced local pain, less blood loss, less postoperative pain, quicker recovery, and shorter durations of hospitalization.,,,, However, the MIS procedures were previously found to show no significant benefits with regard to clinical and radiographic outcomes. Nonetheless, when clinically feasible, MIS procedures are usually preferred over open approaches by patients once the patients have been well informed of possible surgical options. The known benefits of MIS procedures do not, however, offset their limitations of reduced orientation, steep learning curves, increased radiation exposure, dependency on technology, and high surgical cost. Conventionally, MIS procedures rely heavily on the indirect visualization of anatomic landmarks with the use of intraoperative mobile C-arm fluoroscopy for the accurate localization. With the advent of new technologies, however, the localization of the anatomic structures of the spine can be performed with assistance from the BrainLab navigation system with registered 3D intraoperative images generated from robotic C-arm fluoroscopy. The application of the navigation system improved safety for screw insertion due to its high accuracy with relatively minimal radiation exposure of medical staff members and surgeons. The accuracy can reach as high as 99.6% in image-guided spinal navigation in TLIF with PPS placement. In addition, the DRR images generated are comparable to conventional C-arm fluoroscopic images [Figure 3], with the DRR images allowing the clear visualization of each pedicle entry point. The exact localization of the entry points for pedicle screw insertion is made easy even for surgeons who are unfamiliar with the new guided system. This would account for the short learning curve for experienced spinal surgeons and for the associated reduction in the radiation exposure of the surgeons.
|Figure 3: Coherency of digitally reconstructed radiograph and fluoroscopic images. The axial view (a) and sagittal views of lumbar spine in Dyna-computed tomography images (b), digitally reconstructed radiograph (c), and mobile C-arm fluoroscopic image (d) showed a congruent tract of a navigable tap. Hence, the navigation system is reliable for screw placement|
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There have been significant revolutions in the development of safer imaging-guided techniques for spinal fixation. With the BrainLab navigation system, accurate and real-time localization of surgical anatomy can be achieved. Mason et al. have demonstrated that 3D fluoroscopic image-guided pedicle screw placement is highly accurate when compared to conventional or 2D fluoroscopic image-guided methods. At the lumbosacral level, the accuracy of pedicle screw instrumentation improved from 75.9% to 96.7% when comparing conventional fluoroscopy to 3D intraoperative fluoroscopic navigation. As for the present study, we found that the placement of all the navigated pedicle screws was rated as Grade A or Grade B placement, while none of the screws had Grade C or Grade D rated placement. Meanwhile, for the nonnavigated freehand technique group, the G and R scale could not be applied as the surgeries were not particularly performed in the hybrid OR and Dyna-CT images were not obtained. However, there were no patients in Group 2 who reported new neurological deficits postoperatively. Therefore, no revision surgery was performed in our patients. Both the groups did not report any wound infections or significant intraoperative blood loss.
In spinal MIS, radiation exposure has been a major concern for the surgeons and OR staff members. Radiation exposure can be significant, especially in longer segmental fusions and revision surgeries. Kim et al. have demonstrated that navigated MIS results in significantly reduced intraoperative radiation exposure when compared with open-TLIF using standard fluoroscopy., Apart from the lower intraoperative radiation exposure, navigation-assisted surgery could also reduce the number of fluoroscopic images taken during the placement of pedicle screws.,,,,, Villard et al. have reported a 50% reduction in the occupational radiation exposure of surgeons when assisted by 3D-fluoroscopy navigation compared to the nonnavigated freehand technique. Experimental and clinical studies have also reported that radiation exposure is reduced with navigation-assisted fluoroscopy compared with conventional fluoroscopy., We reported similar results in which the mean numbers of total fluoroscopic images taken were significantly lower at 16.3 ± 14.0 and 21.7 ± 10.8 for the 3D-fluoroscopy navigation-assisted two-level and three-level lumbar MIS, respectively, compared with 79.4 ± 7.3 and 120.6 ± 23.5, respectively, for the freehand technique [Table 2]. These lower numbers of fluoroscopic images would account for the lower radiation exposures of the surgeons and staff members.
The present study further showed that the operation time was significantly prolonged when the navigation system was utilized in comparison to nonnavigated instrumentation for the two-level surgeries (130.9 min vs. 105.4 min, P < 0.001). Nevertheless, it is worth noting that there was no significant difference in the operation time for the three-level lumbar surgeries. We believe that the longer average operation time in our two-level lumbar diseases with the navigation system maybe due to our unfamiliarity with process of setting up the image-guided system, the attachment of reference frame, and the acquisition of 3D data. These procedures can be time consuming and demanding, but they are also essential to ensuring a smooth noninterrupted workflow. In the stage of getting familiar with the navigation system, the navigation-assisted PPS placement was initially performed on patients' initial two-level lumbar diseases. We doubted the accuracy of the 3D fluoroscopy–navigation system. Therefore, we performed operation under the guidance of both 3D fluoroscopy–navigation system and with repeated mobile fluoroscopic imaging for pedicle screw placement accuracy verification in some of our initial cases, which may also contribute to the significant prolonged operation time [Figure 3]. The current study revealed, however, that the system is indeed very reliable. Therefore, after these cases, the mobile C-arm fluoroscopy was only engaged for preoperative localization and final radiographic checking of the screw positions which contributed to lesser intraoperative fluoroscopic images taken.
There are several limitations to our study. First, our study utilizes the number of fluoroscopic images taken intraoperatively as an indirect indicator for the radiation dosage exposed to patients. The duration of each fluoroscopic image taken may result in the differences in radiation emissions. As the radiation dosimeter was not available during the surgery, the actual radiation dosage could not be accounted for. However, we estimated that nearly all fluoroscopic images were taken with a single click on the button of the controller. Second, the radiological outcome through the G and R scale is used to define the screw placement accuracy, and functional outcome was not assessed in our study.
| Conclusion|| |
Intraoperative 3D fluoroscopic imaging with navigation assistance for minimally invasive spinal surgery is safe and highly accurate for pedicle screw placement. Navigated MIS reduces radiation exposure of the surgeons and OR staff. Although navigated MIS may result in prolonged operation time, this can be shortened with improved familiarity with the navigation system and an uninterrupted workflow.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]