SCIENTIFIC PAPERS

INTELLIGENT X-RAY BASED TRAINING SYSTEM FOR PEDICLE SCREW PLACEMENT IN LUMBAR VERTEBRAE
Diana POPESCU1, Ctlin Gheorghe AMZA2, Dorel Florea ANANIA 3, Gheorghe AMZA4, Dumitru CICIC5
ABSTRACT: The paper presents an on-going research project for developing an automated intelligent

X-ray based system for assessing screws positions in the vertebral pedicle. The purpose of the system is double, it can be used for surgeons training in pedicle screw insertion procedure, but also for evaluating surgical drill guides design to be used in the same surgery. Automating the processes of inspecting the screw placement and assessing the screw deviations from the ideal position, have the advantage of reducing the surgeon learning curves in performing a complicated surgical procedure. Moreover, developing and evaluating patient specific spinal drill guides is useful for improving the screw insertion and for reducing the surgeon irradiation exposure during the surgery. KEY WORDS: medical modelling, pedicle screw, vertebra, X-ray system, image processing.

INTRODUCTION

The current paper presents an on-going research project in which an innovative intelligent X-ray system is developed with a double purpose (see Figure 1): 1. testing different designs of spinal drill guides created for increasing the pedicle screw placement precision in lumbar vertebrae; 2. developing a training system for both un-experienced and experienced surgeons, which will help them to improve their skills by an automated calculation of the trajectory deviation from the ideal one (traditionally along the pedicle axis). For the first objective, using a real vertebra or a polyurethane model as the one presented in Figure 2, the screws are placed in the vertebral pedicles with the aid of surgical drill guides with different designs. Then, the deviation between the ideal trajectory and the trajectory materialized by the drill guide is assessed using the X-ray intelligent automated system. For the second research objective, a trainee surgeon using a free hand technique inserts the screws within the pedicles and the X-ray system, based on a database containing human knowledge of possible implantation trajectories, calculates the deviation of the real trajectory and offers different messages for correcting the screw placement. This training system is intended to help surgeons to improve their performances in terms of insertion accuracy and to assist them during the rehearsal of the surgery.
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Due to the fact that the system is fully automated, the radiation exposure of the operator/surgeon is minimal. Another advantage of the system is that the visual evaluation is replaced with intelligent inspection, less prone to error.

1.1

Previous research work

, , , , Universitatea Politehnica din Bucuresti, Facultatea de Ingineria si Managementul Sistemelor Tehnologice, Splaiul Independentei 313, sector 6, 060042, Bucuresti, Romnia E-mail: diana@mix.mmi.pub.ro

A review of the literature in the field and of the usual clinical practice reveals that training along a senior surgeon represents the routine for a correct identification of the anatomical landmarks, entry point site and pedicle screw insertion trajectory. Also, there are studies analyzing the performance of residents (Wang, 2010), (Gonzalvo, 2009) and the learning curve in an attempt to find the best training method and computer-based alternatives. Due to the importance of a proper placement, researchers and companies in the field are developing specific devices (e.g. PediGuard), robotic guided pedicle insertion system (Pechlivanis, 2009) or virtual reality based spine surgery simulation system, which can help improving the accuracy or reduce the learning time and effort. Developing applications and specific haptic devices for virtual bone surgery are current approaches for teaching the motor skills and generating different training scenarios. A state of the art in this field, as well as the design of a medical simulator for temporal bone and mandible is presented in (Morris, 2006). Also, (Ct, 2010) presents a virtual collaborative training simulator for scoliosis surgical treatment. However, even when these aids are used, verification of the screw insertion is still made using radiological techniques, as the most reliable evaluation method.

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To the best of the authors knowledge, the literature presents only one computer-assisted training system based on X-ray for pedicle screw implantation (Fang, 2005). The system presented by Fang uses Xray imaging and a 3D digitizer for real-time guidance of the pedicle insertion. A senior surgeon indicates the entry point and the optimal trajectory, then the systems guides the trainee in placing the screw within the safety area. One of the disadvantages of this approach is the trainees and trainers exposure to X-ray radiation during the whole instruction process. Our approach considers an automation of the entire process, which refers to automated determination of screw diameter and ideal trajectory using the 3D CAD model of the vertebra (CATIA V5 CV5), automated placement of the vertebra with the inserted screw in the X-ray analysis area and automated detection and assessment of the deviation from the ideal insertion path.

PEDICLE SCREW INSERTION PROCEDURE

Spinal stabilization, used for treating different pathologies such as: listhesis, spinal instability, spondylosis, lumbar burst fractures etc., requires the use of screws inserted in the vertebral pedicles and

connected with corrective rods for obtaining an optimal alignment of vertebrae and re-establishing the natural spinal curves. This surgical procedure is complicated due to the small safety area for placing the pedicle (Olsewski, 1990), (Lien, 2007), to the large variation of pedicle dimensions and orientations and to the vicinity of neural structures, therefore the need of years of clinical training for beginners along an experienced surgeon. Usually, in the free hand techniques, the entry point for pedicle screw is visually chosen by the surgeon and the insertion trajectory is determined by palpation and mentally reconstructing the position of the vertebra according to the information gathered also during the surgery planning stage (using a CT or MRI). The entry point and the trajectory along the pedicle axis impose a certain insertion angle in sagittal plane, in order to avoid harming the vertebral wall and to ensure that the screw is inserted 80% in the vertebral body for a durable fixation. During the implantation, in order to improve the screw placement, the surgeons use different medical imagistic techniques (C-arm fluoroscopy or conventional Xray), which expose them (especially their hands) to radiation.

Figure 1. Methodology and system for evaluating the screw placement in vertebral pedicle

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MATERIAL AND METHOD

Figure 2. Physical polyurethane prototype used for testing the inspection system

Corrective rod

Pedicle screw

Vertebra

Figure 3. Pedicle misplacement in sagittal plane

Vertebral body

Pedicle screw

For research and testing purposes we used polyurethane foam made vertebrae (Popescu, 2010), manufactured by milling on a PC Mill 100 Emco (main spindle speed 60-5000 rot/min; feedrate 03000 mm/min, workspace: XxYxZ 185mmx100mmx100mm, machining precision 20m). Information from literature (van Dijk, 2001) showed that polyurethane rigid foam can be used as material for practicing or rehearsing different procedure in spine surgery. From this category of material is Sikablock M300, density 0.24 g/cm, compressive strength: 4 MPa, flexural strength: 5 MPa, modulus of elasticity: 150 MPa, used for building the physical prototype of the vertebra. The total machining time estimated in CV5 was 3.2h and the real machining time measured on the machine tool was 3.5h. The 3D model of a L3 vertebra was reconstructed starting from CT scan data, using Mimics 10 software. CATIA V5 (CV5) software was used for generating the solid model (Digitized Shape Editor, Generative Shape Design, Part Design workbenches) and machining (Advanced Machining workbench) the vertebra. Due to the high geometrical complexity of this anatomical structure, special attention has been paid to determining the milling strategy/strategies which can ensure the best accuracy of the model. The vertebral arch and half of the vertebral body were manufactured keeping a part of the block with plane faces (not machined, see fig.2) as references for positioning and orienting the vertebra in the X-ray system. The accuracy of the manufactured vertebra was assessed by 3D scanning.

Neural canal

Figure 4. Screw misplacement in transverse plane

Therefore, the use of a surgical guide personalized for each patient that materializes the drilling direction in the pedicle, will reduce the irradiation dose. One of the factors deciding the success of this surgical procedure is the correct placement of the screw within the pedicle walls. However, despite the use of radiological control techniques during surgery, the literature in the field (Amato, 2010), (Mirza, 2003) mentions a failure rate up to 8-13% due to pedicle screws misplacement (fig.3-4).

Figure 5. Machining on EMCO PCMILL 100: 1.Main spindel, 2. Sandvik Mill; 3. workpiece; 4. clamping device; 5. machine table

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The scanning process was applied for two different orientations of the vertebra (in order to ensure the scanning of the entire vertebral arch and neural channel), and the point clouds obtained by measurements were merged. The mesh thus obtained was compared with the point cloud from Mimics 10, the result showing the suitability of using this manufacturing process for producing vertebra models.

3.1

3D modelling of vertebra

The virtual three-dimensional model of the vertebra was obtained from CT scan data following the steps described in figure 1. Figure 6 presents the 3D model in Mimics 10 and figure 7 shows a deviation analysis between the model imported in CATIA V5 (CV5 in .stl format) and the surface model automatically generated in the same software. In order to automate the determination of the pedicle minimal cortical width (isthmus) which allows the calculation of the optimum diameter of the screw, a CV5 VBScript macro was created. The user input consists in establishing a point on pedicle surface as a starting point for generating different planes, parallel to sagittal and transverse planes. These planes are intersected with the vertebral pedicle, which has an almost oval shape (fig.8) and the pedicle isthmus is determined by comparing the length of the intersection lines and choosing the minimal one. Screw diameter is calculated as 70-80% of the pedicle isthmus. In order to avoid possible miscalculation caused by the specific shape and orientation of the pedicles, the distance between the planes created in the macro is 0.05mm, for the whole pedicle length. This length was set based on the average value from morphometry measures. Also, the same VBScript generates the pedicle screw ideal trajectory, which starts from an entry point placed according surgeon specifications (Magerl technique (Hailong, 2009), for instance) and passes the midpoint of pedicle isthmus (fig.9). This ideal pedicle axis path is superposed on the path generated by the surgeon during the training and the automated X-ray system, based on Zdichavsky grade classification (Zdichavsky, 2004), offers relevant information on the insertion accuracy and possible need to reposition the screw. The procedure mentioned above is specific to each patient, thus a drill guide/guides which materializes the insertion trajectory/ trajectories has to be build individually.

Figure 6. 3D data creation in Mimics 10

Figure 7. Deviation analysis between point cloud data and generated surface of the vertebra

Figure 8. Determination of the pedicle minimal cortical width

The design of the drill guide, as well as issues regarding the material, manufacturing process and clinical testing will be discussed in further articles.

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Pedicle Isthmus

Pedicle axis

Figure 9. Pedicle axis and isthmus determination

3.2

X-ray imaging inspection process

Once the physical lumbar model is manufactured, one can use such a model for instructional activities: the insertion of pedicle screw and the automated evaluation of the insertion precision, as well as for the testing of drill guides. In the case of pedicle screw insertion, the evaluation process implies taking an X-ray image of the manufactured lumbar vertebra. This image is then subsequently automatically analyzed by a computer algorithm and the insertion precision is measured. The proposed system, an implementation of a general pattern recognition (PR) system, comprises the following units or systems (fig.10): - Image acquisition system means of generation of X-ray images of the inspected product and means of transmitting them to a computer; this paper proposes the acquisition of a dual-band energy image of the vertebra (one view is taken with a low-energy of the Xray radiation and another one with a highenergy radiation); the reason behind this, is, that, depending on the position of the vertebra and the screw when inspected, one might miss the correct position of the screw due to the same combined energy absorption coefficient (the screw will be merged with the background in the obtained X-ray image). - Image pre-processing system techniques for enhancing the X-ray images for intermediate level image processing (contrast enhancement, background removal, noise removal, etc.); - Image segmentation system a Hopfield Neural Network (Hopfield, 1984), (Hopfield, 1985) module that partitions the X-ray image

into meaningful classes for further higher level inspection; this is required in order for the system to automatically extract the pedicle screw as a separate object from the X-ray image - High level detection system a module that measures, based on various calculations on the original image and on the segmented image, the deviation from an ideal position of a pedicle screw; this module first extract the segmented pedicle and then it compares its position to an ideal position that it is incorporated within the system. A summary of the general X-ray imaging inspection process is presented below: Step 1 Acquire the X-ray image or images of the inspected product Step 2 Low-level image processing of the resulting image or images X-ray image or images pre-processing X-ray image segmentation using a Hopfield Neural Network (HNN) (Amza, 2010) Pedicle screw extraction for the obtained segmented image Step 3 High-level detection of the insertion precision of pedicle screw Feature extraction for the pedicle screw position, rotation angle, size, etc. High-level detection of the deviation from an ideal position of the pedicle screw; this is based on comparison between the features extracted in the previous step and the values stored in a database for ideal cases; a deviation degree is automatically computed at this step. Step 4 Final product acceptance or rejection based on the deviation degree computed at the previous step and the evaluation system used. Human experience has to be incorporated into the design of such a training system. The knowledge obtained using experiments by human expert is gathered into a common database that is used along the entire inspection system (pedicle screw knowledge database). The knowledge database contains general data about the pedicle screw (such as physical and chemical characteristics), data about the possible errors that may appear and any other information directly or indirectly related to the training process. The end-user (trainee) has to be able to incorporate preferences in the training process. As a result, a module for specific training needs is used to obtain flexibility from an end-user point of view,

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Specific training needs

Pedicle screw knowledge data-base

IMAGE PROCESSING SYSTEM X-ray image acquisition system X-ray image preprocessing Image segmentation Post processing and feature extraction of the pedicle screw High- level detection

Low level image processing

High level image processing

Deviation from an ideal case

Figure 10. X-ray inspection system units

as depicted in figure 10. The user preferences have to be taken into account in most of the image processing stages, from the low-level image pre-processing to the high level detection of errors.

ACKNOWLEDGEMENTS

CONCLUDINK REMARKS

The paper presents the first research steps for developing an automated intelligent system based on X-ray for evaluating the pedicle screw placement accuracy. The methodology for integrating Mimics 10 and CV5 software was developed and tested by building physical prototypes of L3 vertebra from polyurethane foam, which will be further used for testing the system. Moreover, using CV5 software, automated procedures (macro) for generating the pedicle axis and calculating pedicle minimal cortical width were set. The general framework of the X-ray inspection system based on pattern recognition for pedicle screw insertion accuracy was also established. Further research will deal with physically building the system, developing the image processing system, implementing the knowledge database and finally testing the system. Also, based on the pedicle axis and screw diameter determined in CV5, spinal drill guides relying on different vertebra landmarks will be designed. These designs will be also assessed using the proposed intelligent X-ray system.

The work has been co-funded by the Sectoral Operational Programme Human Resources Development 2007-2013 of the Romanian Ministry of Labour, Family and Social Protection through the Financial Agreement POSDRU/89/1.5/S/62557.

REFERENCES

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