This study was partially supported by Point Robotics Medtech Incorporation, which provided the robot system. The funder provided support in the form of salaries for X.Y. Xiao, C.W. Chen, H.K. Chou, and C.Y. Sung, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

All procedures followed were in accordance with the ethical standards of the National Taiwan University Hospital (NTUH) Research Ethics Committee (REC) and the Helsinki Declaration of 1975 (in its most recently amended version). Informed consent must be obtained from all patients if further clinical trial is prepared.
NOTE: The anesthesia procedure can be categorized into three steps: pre-operative evaluation of the patient, intraoperative management, and postoperative management. During pre-o...

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P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Clinical+acceptance+and+accuracy+assessment+of+spinal+implants+guided+with+SpineAssist+surgical+robot:+retrospective+study.">Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study.</a> Spine. 35 (24), 2109-2115 (2010).</li><li>Fan, Y., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Radiological+and+clinical+differences+among+three+assisted+technologies+in+pedicle+screw+fixation+of+adult+degenerative+scoliosis.">Radiological and clinical differences among three assisted technologies in pedicle screw fixation of adult degenerative scoliosis.</a> Scientific Reports. 8 (1), 890 (2018).</li><li>Kantelhardt, S. R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Perioperative+course+and+accuracy+of+screw+positioning+in+conventional,+open+robotic-guided+and+percutaneous+robotic-guided,+pedicle+screw+placement.">Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement.</a> European Spine Joutnal. 20 (6), 860-868 (2011).</li><li>Verma, R., Krishnan, S., Haendlmayer, K., Mohsen, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Functional+outcome+of+computer-assisted+spinal+pedicle+screw+placement:+a+systematic+review+and+meta-analysis+of+23+studies+including+5,992+pedicle+screws.">Functional outcome of computer-assisted spinal pedicle screw placement: a systematic review and meta-analysis of 23 studies including 5,992 pedicle screws.</a> European Spine Journal. 19 (3), 370-375 (2010).</li><li>Ghasem, A., Sharma, A., Greif, D., Alam, M., Maaieh, M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Arrival+of+Robotics+in+Spine+Surgery:+A+Review+of+the+Literature.">The Arrival of Robotics in Spine Surgery: A Review of the Literature.</a> Spine. 43 (23), 1670-1677 (2018).</li><li>Roser, F., Tatagiba, M., Maier, G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Spinal+robotics:+current+applications+and+future+perspectives.">Spinal robotics: current applications and future perspectives.</a> Neurosurgery. 72 (1), 12-18 (2013).</li><li>Chen, H. Y., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Results+of+using+robotic-assisted+navigational+system+in+pedicle+screw+placement.">Results of using robotic-assisted navigational system in pedicle screw placement.</a> PLoS One. 14 (8), 0220851 (2019).</li><li>. NDI Medical Available from: <a target="_blank" href="https://www.ndigital.com/medical/products/polaris-vega">https://www.ndigital.com/medical/products/polaris-vega</a> (2020)</li><li>Gertzbein, S. D., Robbins, S. E. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Accuracy+of+pedicular+screw+placement+in+vivo.">Accuracy of pedicular screw placement in vivo.</a> Spine. 15 (1), 11-14 (1990).</li><li>Kim, T. T., Johnson, J. P., Pashman, R., Drazin, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Minimally+Invasive+Spinal+Surgery+with+Intraoperative+Image-Guided+Navigation.">Minimally Invasive Spinal Surgery with Intraoperative Image-Guided Navigation.</a> Biomed Research International. 2016, 5716235 (2016).</li><li>Bailey, S. I., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+BWM+spinal+fixator+system.+A+preliminary+report+of+a+2-year+prospective,+international+multicenter+study+in+a+range+of+indications+requiring+surgical+intervention+for+bone+grafting+and+pedicle+screw+fixation.">The BWM spinal fixator system. A preliminary report of a 2-year prospective, international multicenter study in a range of indications requiring surgical intervention for bone grafting and pedicle screw fixation.</a> Spine. 21 (17), 2006-2015 (1996).</li><li>Lonstein, J. E., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Complications+associated+with+pedicle+screws.">Complications associated with pedicle screws.</a> The Journal of Bone and Joint Surgery-American Volume. 81 (11), 1519-1528 (1999).</li></ol>

Since 1990, there have been rapid developments in surgical applications involving the use of robots. The available robotic technologies have been optimized, resulting in improved accuracy, overcoming the tremor in human hands, and reduced matching and registration times of navigation systems15. The benefits of surgical robot assistance include: (1) immediate standardization without lengthy learning processes; (2) surgeons can precisely follow the pre-operative plan, which is superimposed on a CT-b...

In the field of spinal surgery, spinal fusion surgery is a fundamental surgical procedure, especially posterior pedicle screw fixation, which can provide three-column support of the vertebrae and enhance the strength of biomechanics; thus, it has become one of the most commonly used surgical procedures1. In many early studies, the clinical effect of posterior pedicle screw implantation has been confirmed, and it has been widely used in surgery for many different spinal disorders, such as degenerative, traumatic, and complicated spinal conditions2.
However, although the posterior lumbar spinal fusion surgery can achieve excellent treatment effects, it is still risky due to the human body anatomy. There are many vital tissue structures close to the pedicle, such as the central nervous system, nerve roots, and main blood vessels. The damage of these tissues during the surgical procedure may cause serious complications, such as vascular injuries, neurological deficits, or screw loosening2,3. Moreover, the surgeons and staff are exposed to additional radiation, particularly in the case of minimally invasive spinal procedures4. Surgeons may experience fatigue and hand tremors after lengthy and tedious spinal surgery procedures, such as screw placements, bone osteotomy, and nerve decompression5.
The unsatisfactory rate of the pedicle screw placement procedure necessitated the proposal for a robotic-assisted navigation system to be applied in spinal surgeries to improve the surgery accuracy and patients&#8217; safety. Several studies on robotic-assisted navigation systems have demonstrated improvements in the safety, accuracy, and precision of pedicle screw placement, as well as decreased radiation exposure and operative times6,7,8,9,10. However, thorough screw trajectory planning, pre-operative planning with images, comprehensive robotic system with fixation device, and robot control software still need to be addressed to achieve this goal. This study focuses on the description of the robotic structure and the workflow of a self-developed navigation system (i.e., the Point spine navigation system (PSNS)) for robotic-assisted pedicle screw placement surgeries.
System description and surgical protocol 
The PSNS comprises a navigation workstation that includes the following. (1) There is a user interface software responsible for image reading through three-dimensional (3D) reconstruction, pre-operative planning, spatial kinematic relationship calculation, and registration. (2) The PSNS uses infrared optical guidance systems to track the spatial position of surgical robots and patients. The infrared optical guidance system contains the following components: (i) an optical tracker that actively emits infrared light and performs stereo positioning through a dual camera (Figure 1); (ii) a marker sphere whose surface has a reflective coating with reflective properties for precise tool tracking; and (iii) a tool with a dynamic reference frame (DRF) that comprises a base and four marker spheres. To avoid the identification failure of the tracking system, each device has a unique DRF design and cannot be shared with each other. The DRF used includes a base frame (BF) attached to the base of the handpiece to confirm the handpiece position, an end-effector frame (EF) attached to the end of the handpiece to confirm the handpiece position, a fiducial frame (FF) anchored on the patient&#8217;s bone to confirm the patient&#8217;s position, and a probe whose tip is used to confirm the target position in 3D space. (3) There is a handpiece comprising a six degrees of freedom (DOF) Stewart platform, with one end of the robot equipped with an operation tool used for drilling the screw path. The handpiece is a robotic-assisted navigation system that assists surgeons toward the accurate placement of implants, such as pedicle screws, or positioning of surgical tools during spinal surgery. The movement of the surgical target is tracked as the robot automatically compensates for the correct target. The robot is designed as a semi-active system that offers surgical tool guidance; however, the actual surgery is performed by surgeons. The operating principle and equipment are illustrated in Figure 2.
PSNS is indicated for procedures including but not limited to the following sample procedures: (i) open, minimally invasive, or percutaneous spinal surgery; (ii) spinal surgery site for thoracic, lumbar, or sacral vertebrae; (iii) posterior spinal fusion for trauma, degenerative stenosis disease, instability, spondylolisthesis, herniated disc, tumor, infection, or spinal deformity correction; (iv) placement of temporary or permanent devices, such as k-wires or needles, while performing vertebroplasty, or either transforaminal or interlaminar percutaneous endoscopic lumbar discectomy; and (iv) bone tumor excision, including the ablation of osteoid osteoma or tumor biopsy, in which the robot directed needles or guidewires to a given vertebral location. This procedure is contraindicated for those with an inability to tolerate anesthesia, surgical procedure, or when satisfactory navigation images have not been acquired.
Note that the operation staff, including neurosurgeons and orthopedic surgeons, must be licensed and trained in guiding courses. All procedures for operating the robot during surgery need to follow the recommended standardized procedures to avoid causing harm to the patient or surgeon. Surgeons must possess conventional surgical experience to ensure that it is possible to switch back to conventional surgical instruments and complete the surgery when it is determined that the navigation is inaccurate, based on the surgeons&#8217; anatomical knowledge.

<table>
	<tbody>
		<tr>
			<td>Dynamic reference frames</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>FF tool kit: 
			1.Connecting Rod 
			2.Combination clamps 
			3.Multi-pin clamps 
			4.Schanz screw 
			5.Spinous process clamp 
			6.Open wrench 
			7.Hexagonal wrench</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Handpiece</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Handpiece holder</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Handpiece stand</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>K-pin</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Optical tracker</td>
			<td>NDI</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Passive spheres</td>
			<td>NDI</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Probe</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Sterile box</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Sterile drape</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Trocar</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Workstation cart</td>
			<td>POINT</td>
			<td></td>
			<td></td>
		</tr>
	</tbody>
</table>

a spine robotic-assisted navigation system for pedicle screw placement

Pedicle screw implantation has excellent treatment effects and is often used by surgeons in spinal fusion surgery. However, due to the complexity of human body anatomy, this surgical procedure is difficult and challenging, especially in minimally invasive surgery or patients with congenital anomalies and kyphoscoliosis deformity. In addition to the abovementioned factors, the surgical experience and technique of the surgeon also affect the recovery rates and complications of the patients after the surgical operation. Therefore, accurately performing pedicle screw implantation has is a constant topic of common concern for surgeons and patients. In recent years, with the technological development, robot-assisted navigation systems have gradually become adopted. These robot-assisted navigation systems provide surgeons with complete preoperative planning before surgery. The system provides 3D reconstructed images of each vertebra, allowing surgeons to understand the patient&#39;s physiological characteristics more quickly. It also provides 2D images of sagittal, coronal, axial and oblique planes so that surgeons can accurately perform pedicle screw placement plan.
Previous studies have demonstrated the effectiveness of robot-assisted navigation systems for pedicle screw implantation procedures, including accuracy and safety assessments. This step-by-step protocol aims to outline a standardized surgical technique note for robotic-assisted pedicle screw placement.

The safety and accuracy of robotic-assisted pedicle screw placements have been addressed in several studies6,11. We match the vertebrae with pre-operative planning images under an optical tracking system in the proposed method. After determining the planned surgical path, this information was transferred to the handpiece through the handpiece control unit. The navigation system integrates the tracking information and displays it on the monitor during the surgery....

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A Spine Robotic-Assisted Navigation System for Pedicle Screw Placement

This article presents a standardized surgical technique for robotic-assisted pedicle screw placement by using robotic-assisted navigational systems. We present a step-by-step protocol and describe the workflow and precautions of this procedure.

Pedicle screw implantation has excellent treatment effects and is often used by surgeons in spinal fusion surgery. However, due to the complexity of human ...

This robot-assisted navigation system is very effective, accurate, and safe. It provides a friendly user interface and automatically compensated handpiece for pedicle screw replacement. The point handpiece of this system has a parallel platform architecture, which has the advantages of a strong load capacity, fast positioning speed, portability, small footprint, and high curvability.This system can be used to perform minimally invasive surgeries, complicated kyphoid scoliosis deformities and other challenging cases. We plan to use the Robotics system in other surgical procedures such as nerve decompression. In contrast to a traditional surgical methods, this system uses a unique technology that allows visualization of the surgical goals and operation steps within the application interface.Demonstrating the procedure with me will be Chin-Wei Chen and Xiu-Yun Xiao, engineers from Point Robotics. After anesthesia and draping, place one percutaneous wire with a ply of 1.5 millimeters on the posterior iliac crest to anchor the fiducial frame to the iliac bone of the saw bone and check the entry point under fluoroscopy. Mark the entry point with ink.Use a power drill set to 1, 000 revolutions per minute to insert the first percutaneous pin into the patient's posterior iliac crest. Use the pin to anchor fiducial frame and adjust the frame until it is recognized by the optical tracking camera. When the frame is in position, use a screwdriver to fix the frame to the pin and use the drill to insert the second percutaneous pin, further securing the frame with the second pin.Mark the surgical field with ink and use a surgical scalpel to make a skin incision along the mark. Then, use a screwdriver to fix the frame to the spinal process of interest and have the surgeon confirm that the frame has been firmly anchored. For spatial labeling and registration, enter the dynamic reference frame monitoring interface to the Point Spine Navigation System software with multiple planar views.All of the dynamic reference frames should be inside the vision area of the optical tracking system. When the dynamic reference frame vector arrow is displayed, the tracker has been stably recognized by the tracking system. To ensure a correct registration, select at least four non-coplanar feature points on the patient's pre-operative 3D reconstruction CT images.Use the tip of the probe to keep in contact with the first feature point within the actual surgical area. Then press Probe Selection'to confirm the access point. When all of the feature points have been confirmed, press Calculation'The system will calculate the result of the landmark registration and present it in the software interface.When the acceptance criteria for the registration accuracy meets the needs of the clinical indications, use the probe tip. Continuously contact any point on the bone surface in the actual surgical area and press the Probe Selection'button to confirm the access points. When at least 50 pic points have been confirmed, press Calculation'The system will calculate the surface matching result and present it on the software interface.Once the registration result has been accepted, use the probe to select the obvious anatomical landmarks of the actual surgical area for confirmation. To assemble the robot, angle the handpiece in space so that the two circles representing the angle of the handpiece coincide in the software interface. Then, horizontally and vertically adjust the position of the handpiece, so that the dots representing the position of the handpiece in the software interface are aligned with the entry points of the planned path.We recommend becoming familiar with the first person orientation of the user interface and the movement we have here of the handheld robot before attempting a surgery. To prepare the pedicle, activate the drill function of the handpiece and drill the instruments mounted on the front end along the planned path. Use the C-arm to confirm the position of the K-pin and the trocar and use the anterior/posterior view to determine whether the instrument is located in the oval area formed by the pedicle in the perspective image.Then, under the lateral view, determine whether the instrument is within the range of the pedicle and the vertebrae. When the K-pin and trocar positions are appropriate for the procedure, replace them with guide wires and insert the pedicle screws through the guide wires. In a previous study, a low-overall screw malposition rate of 1.7%from a total of 59 screws placed on 34 seen vertebrae through the Point Spine Navigation System was demonstrated.No spinal canal perforations or injuries to any other major vessels were observed and all of the pedicle screws were positioned within the safe zone. The robot can, not only drill, but also perform even soft tissue manipulations because of the high accuracy of robot, many surgical procedures can be performed safely. Our team is currently focusing on making the user learning curve easier and providing a supporting arm to reduce the weight of the handpiece.

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