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Kovalenko R.A.

Almazov National Medical Research Center, Akkuratova Str., 2, Saint-Petersburg, Russia, 197341

Rudenko V.V.

Kafedra otorinolaringologii lechebnogo fakul'teta Rossiĭskogo natsional'nogo issledovatel'skogo meditsinskogo universiteta im. N.I. Pirogova, Moskva

Kashin V.A.

V.A. Almazov Medical Research Center, Saint Petersburg, Russia

Cherebillo V.Yu.

Military medical academy of S.M. Kirov, Saint-Petersburg, Russian Federation

Ptashnikov D.A.

Vreden Russian Research Institute of Traumatology and Orthopedics, St.-Petersburg, Russia;
Mechnikov Northwest State Medical University, St.-Petersburg, Russia

Assessment of the safety and accuracy of implantation of screws into the C2 vertebra using individual 3D-navigation matrices

Authors:

Kovalenko R.A., Rudenko V.V., Kashin V.A., Cherebillo V.Yu., Ptashnikov D.A.

More about the authors

Journal: Burdenko's Journal of Neurosurgery. 2020;84(2): 42‑50

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To cite this article:

Kovalenko RA, Rudenko VV, Kashin VA, Cherebillo VYu, Ptashnikov DA. Assessment of the safety and accuracy of implantation of screws into the C2 vertebra using individual 3D-navigation matrices. Burdenko's Journal of Neurosurgery. 2020;84(2):42‑50. (In Russ., In Engl.)
https://doi.org/10.17116/neiro20208402142

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Abbreviations

CT — computed tomography

CII — axis

Implantation of screws into the axis is currently a common technique for various spinal pathological processes. This method is applied in isolated version (Hangman's fracture) and in combination with fixation of other vertebrae (Harms operation, occipitopondylodesis, etc.). Risks and complications of manipulation are well understood. One of them is vertebral artery injury [1]. Anatomical studies allowed us to identify the optimal trajectory for screw introduction considering external landmarks with fluoroscopic control (“free hand” technique). It was shown that this approach requires advanced surgical skill and is often accompanied by malposition of screws, injury of neurovascular structures [2—5].

On the other hand, intraoperative navigation with fluoroscopy or computed tomography (CT) has gained popularity. Navigation-assisted deployment of screws is more accurate and has fewer complications. However, this approach is also characterized by certain disadvantages. These are technical complexity, prolonged learning curve, advanced irradiation of patient, need for repeated surveys in case of displacement of the landmarks, high cost and limited availability of equipment [6—10].

Until recently, 3D printing technology in medicine was predominantly used for more thorough perioperative planning, individual model and implant printing [11, 12]. Currently, a new technology for spinal navigation is created (individual navigation matrices). The essence of the method implies computer modeling of screw trajectory using preoperative CT data and 3D printing of mirror templates reflecting the relief of certain vertebral structures. The template or matrix includes a guide tube for forming a screw passage as a continuation of the trajectory planned on the computer. The matrix is intraoperatively installed to posterior vertebral structures and channels for screw deployment are formed.

The purpose of the study was to analyze safety and accuracy of screw deployment into the axis using individual 3D navigation matrices compared to “free hand” technique.

Material and methods

Sample features

The research was carried out in two centers (Vreden Russian Order of the Red Banner of Labor Research Institute of Traumatology and Orthopedics and Almazov National Research Medical Center).

Treatment outcomes were compared in 2 groups. Group 1 consisted of 23 patients (44 screws) for the period 2010—2016. “Free hand” technique was applied for screw implantation into the axis. Data of patients were retrospectively analyzed. In one case, signs of vertebral artery injury followed screw passage. Therefore, CI—III fusion was performed. Prospective study included 17 patients (group 2, 34 screws) who underwent navigation-assisted installation of screws. All patients signed informed consent. The ethics committee approved the study. Characteristics of study patients are presented in Table 1.

Insertion of 29 transpedicular and 15 pars screws was performed in the 1st group. In the 2nd group, there were 22 transpedicular screws and 12 pars screws.

Design and manufacturing of navigation matrices

Multispiral CT angiography with a slice width of 1 mm was performed in all patients. Primary processing of DICOM files and creation of 3D STL model of vertebrae were carried out in Inobitek DICOM Viewer Professional Edition 1.9.0. Final processing of the model and design of the navigation matrices were performed using Blender 2.78 program. Optimal trajectory of the screw was determined in order to create the matrices. Continuation of this trajectory was the axis of the designed guide. The matrix base was created in accordance with the principle of specular volumetric reflection of posterior vertebral structures (arch, spinous process, articular processes) (Fig. 1).

Fig. 1. Designing of navigation matrices. a — determination of screw insertion trajectories in 3D STL file; b — designing of external axes; c — designing of navigation matrix.

Gcode print file was created in Cura 3.5.1 software. Printing was performed using the technology of jet overlaying of molten polymer filament (Infitary M508 printer). Biodegradable PLA plastic (lactic acid biopolymer) was used. Both matrices and 3D vertebral models were printed.

One-sided matrices with guides were used in the first two clinical cases. This design did not ensure necessary fixation of the matrix on the vertebra and resulted its displacement. Sliding along the vertebral arch during formation of inlet and screw passage was followed by deviation of 2 screws up to 4 mm. Subsequently, we used double-sided matrices. Design of these matrices ensures more tight contact due to bilateral support.

Preoperative planning included comprehensive analysis of 3D-anatomy, final determination of surgical strategy, comparison of the model and matrix, analysis of congruence of their surfaces and matrix-assisted insertion of screws (Fig. 2).

Fig. 2. Preoperative planning. a — comparison of matrices and 3D models of the vertebrae; b — introduction of knitting needles along the guiding structures; c — introduction of screws.
Sterilization of models and matrices was carried out using low-temperature hydrogen peroxide gas plasma that prevented their thermal deformation.

Surgical technique

Standard posterior median approach was used. The key aspect is careful dissection of posterior vertebral structures for close contact of the matrices with the bone. Cautery was predominantly applied for these purposes. Matrix positioning was carried out until sensation of complete juxtaposition of the surfaces. There was no clear juxtaposition in some cases that required extraction of the matrix and its application to 3D vertebral model. Adequate arrangement with respect to the model and patient’s vertebra was visually confirmed. After that, repeated deployment of the matrix was followed by formation of passage under the screw using a drill or Kirschner wire and screw implantation (Fig. 3).

Fig. 3. Intraoperative application. a — sterile 3D model of the vertebrae with navigation matrix; b — application of the matrix to CII vertebra; c, d — position control on the matrix and model; e — formation of a drill passage for a screw through navigation guiding device; f — intraoperative x-ray control.

Evaluation of the results

Safety and accuracy of implantation were assessed using postoperative CT data. Perforation of the pedicle was studied in coronal and axial planes to assess safety of implantation in accordance with the SGT system (screw guide template). The following criteria were used to evaluate the results: degree 0 — the screw is completely inside the bone structures; degree 1 — the screw partially perforates the bone structure, but more than 50% of screw diameter is inside the bone; degree 2 — the screw perforates the bone structure but more than 50% of screw diameter is outside the bone; degree 3 (penetration) — the screw is completely outside the bone (Fig. 4) [13].

Fig. 4. Postoperative CT assessment of implantation safety. Coronal slices at the level of vertebral pedicles. a — screw is completely within the bone (grade 0); b — more than 50% of the screw diameter within the bone (grade 1); c — screw completely perforates outside the bone (grade 3).

Deviation was analyzed in two planes (axial and sagittal) at the most ventral points of intersection of scheduled trajectory and screw axis continuation with vertebral body in layering of CT scans (DICOM) in the Mimics 3D program (Fig. 4). Implantation accuracy was evaluated using the SGT system in accordance with the following criteria: class 1 — screw axis deviates within 2 mm from scheduled trajectory; class 2 — screw axis deviates over 2 mm but less than 4 mm; class 3 — deviation over 4 mm (Fig. 5) [13].

Fig. 5. Assessment of screw deviation through comparison of postoperative CT and preoperative modeling data. a — accuracy class 1; b — accuracy class 2; c — accuracy class 3.

Results

Assessment of deviation in the 2nd group showed that classes 1 and 2 of screw implantation were achieved in 97% of cases. Deviation class 2 was observed in 11 (32.35%) cases. Mean deviation was 1.8±1 mm. Assessment of implantation accuracy in accordance with the SGT system is shown in Table 2.

Analysis of safety showed the following results. In the 1st group (“free hand”), grade 0 and 1 (no malposition or less than 50% of screw diameter) were recorded for 29 (65.91%) screws, grade 2 — for 13 (29.55%) screws, grade 3 — for 2 (4.45%) screws. Intraoperative injury of the vertebral artery without postoperative neurological deficit occurred in 4 (8.89%) patients. In the 2nd group, 28 (82.35%) out of 34 screws were completely in the bone structures, 4 (11.76%) screws perforated pedicles for less than 50% of their diameter (grade 1). There were 2 cases of malposition degree 2 and 3 without vertebral artery injury (degree 3 — cranial malposition with screw exit into the СI—II joint cavity). Analysis of screw implantation safety is shown in Table 3.

Thus, matrices ensured significantly better safety of screw installation compared with “free hand” technique (p<0.05).

Discussion

Transpedicular CII fixation is a reliable method. However, high incidence of complications associated with screw insertion along the wrong trajectories indicates the need for new methods of safe implantation [14]. Bone perforations were observed in most studies although some authors report high safety of “free hand” method [15, 16]. Thus, P. Punyarat et al. reported bone perforations by 12 (23%) screws during transpedicular CII fixation (grade 1 — 10 (19%) screws, grade 2 — 1 (2%) screw, grade 4 – 1 (2%) screw) [17]. R.J. Bransford et al. reported that 83.3% of screws were completely surrounded by the bone. “Free hand” installation of 0.3% of screws into the axis resulted vertebral artery injury [18].

Spinal navigation based on intraoperative CT or polypositional radiography does not exclude the risk of bone perforation with possible complications. J.W. Hur et al. reported that transpedicular CII fixation using O-arm was followed by cortical layer perforation with screw exit for more than 2 mm in 7.6% (10 out of 92) of cases. Two screws perforated vertebral artery [19]. J. Randall et al. reported perforation-free implantation of screws into the axis in 67% of cases that was significantly lower compared with “free hand” group [15]. M. Uehara et al. used intraoperative CT navigation and reported perforation of the axis in 12.5% of cases (degree 3 in 5% of cases) [20].

3D navigation matrix technology is an inexpensive and effective method ensuring reduced risk of intraoperative complications in patients with complex trajectories of screw system implantation. This approach also increases accuracy of screw placement, reduces the number of repeated introductions of the screw and irradiation of a patient. According to literature data, this method demonstrates high efficiency and availability. The last characteristics are similar to those of intraoperative CT navigation [21—23]. In 2014, S. Kaneyama et al. analyzed an effectiveness of navigation matrices for screw implantation into the axis (23 patients, 48 screws). The authors used 3 types of matrices: for determining the insertion point, for forming the passage by a needle, for introduction of the screw. Mean axial deviation was 0.36±0.62 mm, sagittal deviation — 0.30±0.24 mm. Class 1 of implantation was obtained for 46 screws, class 3 – for 2 screws. Class 2 and 3 was observed for 2 screws. No complications were recorded [13].

In 2016, S. Guo et al. reported the results of cadaveric experiment. Implantation with navigation matrices was significantly more accurate (95.8% — grade 1, 4.2% — grade 2) compare with “free hand” technique (grade 1 — 72.7%, grade 2 — 17, 3%, grade 3 and 4 — 4.5% for each class) [24].

The Japanese authors reported high accuracy of implantation during Harms surgery in 2017. Forty-eight screws (24 CI, 20 transpedicular screws into CII, 4 translaminar into CII) were implanted with mean deviation of 0.70±0.42 mm in frontal plane at the level of the middle of the pedicle. All screws did not extend beyond the bone [25].

In 2017, specialists from China implanted 74 screws into СI and СII (37 screws in each group). In the experimental group, the screws were installed using navigation matrices. Thirty-two (86.5%) screws were completely inside the bone, 3 screws (8.1%) perforated the bone for less than 1 mm, reinstallation was not required. Two screws (5.4%) perforated the bone for over 1 mm. In the control group, 23 (62.2%) out of 37 screws were inside the bone, 3 (8.1%) screws perforated the bone for less than 1 mm, 11 screws – over 1 mm (29.73%). Thus, acceptable installation accuracy was 94.6% for navigation matrices and 70.3% for standard fluoroscopy [26].

It should be noted that the described technology is a fundamentally new solution in spinal navigation due to some features. Unlike intraoperative CT navigation, screws are inserted along scheduled trajectories. Prolonged preoperative planning for designing and manufacturing matrices is offset by reduced time of surgery and incidence of re-implantations. Another feature is available designing, manufacturing and application of navigation devices in various institutions that was demonstrated in our study (the matrices designed and manufactured in the same laboratory were used in two different centers). Thus, complex screw implantation may be performed with high accuracy in medical institutions not equipped with CT navigation.

Considering our experience, we concluded the shortcomings of this technology. The first main aspect is long learning curve including the study of 3D designing and printing, development of optimal matrix design, determination of suitable materials and parameters of printing. The second drawback is prolonged preoperative planning including designing, manufacturing and sterilization of the matrix. Intraoperative disadvantages are the need for careful skeletization of the vertebral structures for tight contact with the matrix, possible breakdown of the matrix and its deformation.

Conclusion

Individual 3D navigation matrices is an effective method for screw installation into the axis. This approach exceeds fluoroscopy-assisted “free hand” technique in terms of safety of implantation.

Authors’ participation:

Concept and design of the study — R.K., D.P.

Collection and analysis of data — V.R.

Statistical analysis — V.K.

Writing the text — R.K.

Editing — V.Ch.

The authors declare no conflicts of interest.

Commentary

R.A. Kovalenko et al. reported an innovative method of 3D navigation with matrices for correct installation of transpedicular and transarticular screws for diseases and injuries of superior cervical vertebrae. The authors compare the groups of screw implantation under fluoroscopic control (retrospective analysis) and transpedicular screw insertion through individualized matrices. The last ones were created using CT data and 3D modeling. Undoubtedly, this technique is interesting. However, it is not clear what is the authors’ participation in development of this technology. It should be noted that this technology is widely used in the countries of the Asian region and the USA. Safety and accuracy of guidance were assessed in experimental (Chen XL, Xie YF, Li JX, Wu W, Li GN, Hu HJ, Wang XY, Meng ZJ , Wen YF, Huang WH. Design and basic research on accuracy of a novel individualized three-dimensional printed navigation template in atlantoaxial pedicle screw placement. PLoS One. 2019; 14 (4): e0214460 — publication in the most cited medical journal) and clinica; trials (Wang F, Li CH, Liu ZB, Hua ZJ, He YJ, Liu J, Liu YX, Dang XQ. The effectiveness and safety of 3-dimensional printed composite guide plate for atlantoaxial pedicle screw. A retrospective study. Medicine (Baltimore). 2019; 98 (1): e13769).

In my opinion, it is advisable to compare the group of difficult implantation of transarticular and transpedicular screws with patients undergoing screw implantation under navigation or intraoperative CT control rather “free-hand” technology. This endures reduced screw malposition and injury of nerve or vascular structures. The authors of the last mentioned report (Wang F.) revealed significantly (94% versus 73%) better accuracy of craniospinal screw installation under navigation matrices compared to traditional methods of fluoroscopic control and navigation. These data correlate with the results of the authors of this research.

3D printing in neurosurgery is widely discussed regarding convenience of preoperative printing of models and positioning systems and legality of using these models in operating theatre. There is an opinion that these models should be also certified for legal use in surgical wound. However, wide application of this method will be impossible in this case. The manuscript deserves publishing considering the importance of 3D modeling in operating theatre and annual incidence of upper cervical spine trauma (over 25 cases per 1 million).

A.O. Gushcha (Moscow, Russia)

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