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ClinicalApplication and EfficacyAnalysis of 3D Navigation Module
in the Treatment ofAtlantoaxial Instability
Research article
Clin Surg Res Commun 2018; 2(4): 1-10
DOI: 10.31491/CSRC.2018.12.023
Yong-xiong He et al 1
Bo-kang Lv a,#
, Xing Wangb,#
, Erbin Ab
, Fei Gaob
, Yan-qiang Huanc
, Le-meng Chaoc
, Jian-feng Liuc
,
Fei Wangc
, Yong-xiong Hec,
*, and Bin Liud,
*
Abstract
Background: Posterior cervical atlantoaxial pedicle screw fixation is a very effective treatment for atlantoaxial
instability (AAI). However, due to the complex anatomy of the cranial-cervical junction, the accuracy and safety
of posterior atlantoaxial pedicle screw placement remains extremely challenging.
Objective: To quantitatively evaluate the safety and accuracy of the 3D navigation module to assist the
posterior atlantoaxial fixation.
Methods: A total of 20 AAI patients were selected between June 2014 and September 2015. The Mimics v10.1
and 3-matic software were used. The 3D navigation module was designed as a double-sided positioning hole
guide with a guide rod. All patients underwent posterior atlantoaxial posterior pedicle screw fixation with
3D navigation module. The actual entry point and screw trajectory were measured after operation, which
were compared with the ideal entry point and screw trajectory. The Japanese Orthopaedic Association (JOA)
score was measured before and after surgery to evaluate the neurological function improvement. The average
operation time, blood loss, and frequency of intraoperative fluoroscopy were counted.
Results: The posterior atlantoaxial pedicle screw fixation with a 3D navigation module was successfully
performed in all patients. A total of 80 atlantoaxial pedicle screws were implanted in the 20 patients.
Postoperative CT scan showed that two pedicle screws deviated from the medial aspect of the atlas pedicle
cortex and entered the spinal canal approximately 1 mm, without causing neurological complications. There
was no significant difference between the ideal and actual entry points or ideal and actual screw trajectories
of the atlas and axis (P > 0.05). The preoperative JOA score was 12.45 ± 1.15 and postoperative JOA score was
15.5 ± 0.89, with statistically significant difference (P < 0.05).
Conclusion: It was safe and effective to use the 3D navigation module to assist the posterior atlantoaxial
pedicle insertion, with a high accuracy of pedicle screw placement.
Keywords: atlantoaxial instability; pedicle screw; 3D navigation module; rapid prototyping
#
These authors contributed equally to this work.
*Corresponding author: Yong-xiong He
Mailing address: Department of Spine Surgery, Inner Mongolia
People’s Hospital, Saihan District Zhao wuda road No.42,
Hohhot 010017, Inner Mongolia, China.
E-mail: spinedoctor@sina.com
Tel: +86-0471-2243347
*Corresponding author: Bin Liu
Mailing address: Inner Mongolia Medical University, Hohhot
010110 Inner Mongolia, China.
E-mail: blnm@sina.com
Received: 15 November 2018 Accepted: 15 December 2018
atlantoaxial pedicle screw fixation [1-3]
. The cervical
spondylosis requiring internal fixation was generally
caused by multiple injuries and such injuries were
often combined with fracture dislocation, leading to
the destruction of its three-column structure. In 1994,
Abumi, et al. [4]
successfully applied and promoted
the posterior cervical pedicle screw fixation in the
treatment of lower cervical injury. Because the pedicle
screw fixed the three columns (anterior, median, and
posterior) of the vertebral body and thus provided a
good three-dimensional fixed pattern, it has obvious
advantages compared with other fixed methods by
biomechanics [5]
. However, as the cervical vertebra has
a complex anatomical structure and an important adja-
cent relationship, and the pedicle is relatively slender
INTRODUCTION
In recent years, patients with atlantoaxial instabili-
ty (AAI) have been routinely treated with posterior
a
Zhengzhou University fifth affiliated hospital 450000, henan province , China.
b
Department of Spine Surgery, Bayannaoer Hospital, Linhe 015000, Inner Mongolia, China.
c
Department of Spine Surgery, Inner Mongolia People’s Hospital, Hohhot 010017 Inner Mongolia, China.
d
Inner Mongolia Medical University, Hohhot 010110 Inner Mongolia, China.
Creative Commons 4.0
Published online: 25 December 2018
ANT PUBLISHING CORPORATION
Yong-xiong He et al 2
with great angle change, the most common and most
serious surgical complications are C2 nerve root and
vertebral artery injures that are caused by the pedicle
screw trajectories deviating from the pedicle cortex [6]
,
which makes the clinical application of posterior cervi-
cal pedicle screw fixation extremely limited. Therefore,
how to improve the accuracy of screw placement and
reduce surgical complications is an important problem
that needs to be solved urgently in clinical work.
The cervical pedicle screw fixation methods currently
used in the clinic include bare-handed screw-setting
[7]
, screw-setting assisted by the imaging techniques,
computer-assisted orthopaedics surgery (CAOS) [8]
, and
3D printing technology that was also called comput-
er-aided design-rapid prototyping (CAD-RP technolo-
gy). The key points of the bare-handed screw-setting
are the accuracy of the point and direction of the screw,
rich experience, and intraoperative fluoroscopy. The
screw-setting assisted by the imaging techniques has
high requirements for doctors' knowledge accumu-
lation, experience judgment, and spatial imagination,
causing certain subjectivity and lacking objective mea-
surement standards. CAOS makes intraoperative sur-
gery more precise, safe and effective, but its expensive
equipment costs and operational complexity limit its
promotion and application [9-11]
. The CAD-RP technique
was first applied to lumbar pedicle screw placement
by Radermacher et al. [12]
. It is a kind of modern digital
orthopedic technology. Its principle is to scan the struc-
ture of tissue and organ through CT, generate a propor-
tional 3D module corresponding to the real object, and
make a solid model proportional to the patient through
the 3D printer; through the solid model, the surgical
simulation and intraoperative reference and appli-
cation are performed [10]
. The rapid prototyping drill
guide template designed by 3D printing technology can
help improve the accuracy of the screw placement [13-16]
.
In this prospective clinical study, we designed a drill
guide template for atlantoaxial pedicle screw place-
ment. The purpose of this study was to quantitatively
evaluate the accuracy of placement of atlantoaxial ped-
icle screws using a drill guide template.
MATERIALS AND METHODS
Subjects
All patients signed written informed consent. In ad-
dition, this study followed the principles outlined in
the Helsinki Declaration. Patients with atlantoaxial
instability (AAI) who were hospitalized and surgically
treated in our hospital from June 2014 to September
2015 were enrolled in this prospective study. A total
of 20 patients who underwent AAI posterior approach
(17 Male and 3 female), with an average age of 42.6
years (age range 22-46 years), were selected based on
the inclusion and exclusion criteria. All AAI patients
underwent posterior atlantoaxial pedicle screw fixa-
tion with a drill guide template. All protocols have been
approved by the Committee of Inner Mongolia People’s
Hospital.
Diagnostic criteria: All patients were diagnosed with
AAI by clinical and imaging examinations and had clini-
Figure 1. A. The atlantoaxial and drilling guides produced by Mimics software. B. Atlantoaxial models and drilling guides
generated using rapid prototyping techniques. C. 3D module disinfection backup and 3D module placed on the spinous
process of the axon. D. The accurate internal fixation showed by postoperative X-ray.
Yong-xiong He et al 3
Clin Surg Res Commun 2018; 2(4): 1-10
cal symptoms.
Inclusion criteria: patients who meet the diagnostic
criteria; patients who can be placed with the atlantoax-
ial pedicle screw by X-ray, computed tomography (CT),
and magnetic resonance imaging (MRI) examinations;
patients whose surgeries were performed by the same
senior physician.
Exclusion criteria: patients with severe vertebral injury,
malformation, small posterior arch, etc.; patients with
advanced age, combined with serious medical diseases
and osteoporosis, unable to tolerate surgery; patients
with infection, tuberculosis, tumor, and other complica-
tions; patients who had a mental illness.
Construction of 3D navigation module
Software Platform
Mimics (Materialise's interactive medical image con-
trol system), known as "Dream Factory of Medical
Imaging", is a medical image control system developed
by Materialise of Belgium to realize interoperability.
Through this software, various medical imaging mate-
rials such as CT, MRI, and other two-dimensional data
are imported, and then the image data are analyzed
by the clinician on three different orthogonal planes:
cross-section, coronal plane, and sagittal plane. The
valuable areas are optimized to get the desired data,
and then the 3D data model is rebuilt. Through the sur-
gical simulation operation, virtual surgical operations
can be performed in the software, such as pre-surgical
program and prosthesis placement. Mimics can per-
form 3D reconstruction of imaging data, providing sup-
port for a variety of supporting software applications
such as virtual reality (VR), computer-aided design
(CAD), finite element analysis (FEA), and rapid proto-
typing (RP). Therefore, Mimics can be used for clinical
diagnosis, surgical simulation (pre-surgical program,
virtual surgery operation, prediction and analysis
of surgical risk), and can also be applied to anatomy
teaching and scientific research. It has great potential
for functional development [17]
.
3-matic is a forward engineering based on Digital
Standard Triangle Language (STL) produced by Ma-
terialise. It can directly edit and modify STL format
files to implement FEA/CFD processing in various STL
formats. All operations of 3-matic are based on digital
form (triangle based) for stretching, rotation, array-
ing, etc. It can directly copy and paste the anatomical
data in Mimics software, and can input them into any
CAD document. Through 3-matic, we can implement
3D measurement and engineering analysis, design
implants and surgical guidelines for specific patient
surgeries, and prepare anatomical data or implants for
finite element simulations. This study used 3-matic to
create a personalized navigation template for atlanto-
axial pedicles, which greatly reduced the time required
to create navigation templates using traditional reverse
engineering [17]
.
Atlantoaxial pedicle screw simulation placement
All patients underwent cervical CT with a tomographic
thickness of 0.625 mm. CT images were imported into
Mimics software and the atlantoscopic 3D model was
constructed. In the virtual environment of the Mimics
software, a cylinder (3.5 mm in diameter) was created
as an atlantoaxial pedicle screw, which is because it is
easier to make and adjust the position of the cylinder
in the software. The ideal trajectory of the atlantoaxial
pedicle screw was created and adjusted by directly ob-
serving the relationship between the cylinder and the
pedicle cortical bone in different planes.
Production of atlantoaxial 3D guide module
Then the 3D model of the atlantoaxial vertebral body
and the cylinder was introduced into the 3-matic (Ma-
terialise) software to design a 3D drilling guide module
with drilling guidance. In the 3-matic software, the sur-
face of the template (2.5-mm thickness) was created as
the opposite side of the posterior atlantoaxial surface,
thus providing a perfect fit between the template and
the posterior atlantoaxial surface. Using a Boolean sub-
traction operation, two position holes (3.5-mm diame-
ter) were created on both sides of the template surface
based on the data of the cylinder. After the cylinder was
interactively translated, two guide holes (3.5-mm di-
ameter) were created on the optimum entry points on
either side of the template surface. The direction of the
drill guide hole was exactly the same as the optimum
nailing direction. The local Boolean operation was used
to combine the drill guide hole and the template sur-
face with the positioning hole into one unit .
Physical molding of 3D guides
The DICOM format of the cervical CT of the patient
was introduced into the Mimics software, and the at-
las template of interest was obtained by operation of
thresholding, region growing, crop mask, editing mask,
etc. Then the atlas template selected, followed by the
click of the “Calculate 3D” button to complete the 3D
reconstruction of the atlas. The 3D model of the atlas
was displayed in the 3D viewport and was smoothed,
reduced by triangle reduction, etc. The final 3D model
of the atlas was obtained, and then imported into a 3D
printer to print out the patient’s atlantoaxial model us-
ing a photosensitive resin material.
Surgical procedures
DOI: 10.31491/CSRC.2018.12.023
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Yong-xiong He et al 4
cross-sectional angle and sagittal angle between the
ideal screw trajectory with the actual screw trajecto-
ry. Besides, the patient was routinely examined by CT
after surgery, and the picture archiving and commu-
nication system (PACS) measurement tool was used
to display the relative positional relationship between
the screw and the pedicle according to the CT slice.
Screw-setting accuracy was evaluated by the methods
provided by Yoshiharu et al. [18]
, Miyamoto et al. [19]
, and
Yasutsugu et al. [20]
. Grade 0: The screw is completely
placed inside the pedicle; Grade I: the screw penetrates
the pedicle bone cortex ≤ 2 mm, without neurological
or vertebral artery injury and other complications
associated with screw placement; Grade II: screw
penetrates the pedicle bone cortex> 2mm, without
neurological or vertebral artery injury and other com-
plications related to nailing; Grade III: neurological or
vertebral artery injury and other complications related
to screw placement occur.
Evaluation of the entry points
In order to properly compare the ideal and actual
coordinates of the entry point, the axis of the atlanto-
axial axis was adjusted. For C1, the front nodule was
treated as the origin of the coordinate axis. The x-axis
passed through the origin of the coronal plane and
was parallel to the line connecting the lowest points of
the lower articular processes on both sides. The y-axis
and the z-axis passed through the origin and were per-
pendicular to the x-axis of the horizontal and coronal
planes, respectively. In the case of the C2 vertebra, the
midpoint of the line connecting the lowest points of
the articular processes on both sides was regarded as
the origin. The y-axis and the z-axis passed through the
origin and were perpendicular to the x-axis of the hori-
zontal and coronal planes, respectively.
Evaluation of neurological function improvement
The JOA score was used to evaluate the neurological
function of the patient before and 6 months after sur-
gery. The score was divided into 17 points. The higher
the score, the better the neurological function.
Statistical analysis
Statistical analysis was performed using SPSS 13.0
statistical software. Data were expressed as mean ±
standard deviation. The comparisons were performed
using paired-sample t-test. P < 0.05 was considered as
significantly different.
RESULTS
Statistics of postoperative general results
All patients successfully underwent surgery with the
aid of a drill guide template. Five of the 80 screws were
All operations were performed by the same senior
surgeon. The patient was placed in the prone position
under general anesthesia and the head was fixed by the
Mayfield head frame. The median incision of the pos-
terior neck was taken and separated layer by layer to
fully reveal the posterior structure of the atlantoaxial
vertebrae, including the posterior tibial tuberosity and
posterior arch, lamina, and lateral vertebral blocks. The
soft tissue covering the bony structure was completely
peeled off by subperiosteal peeling to make the drill
guide template to be fully compatible with the posteri-
or surface of the vertebra. The drill guide was fixed and
the guide hole was drilled through the template posi-
tioning hole, followed by the drilling of the trajectory
parallel to the guide rod of the template. The probe
was used to detect the four walls of the nailing channel
were leaking. The intraoperative fluoroscopy was used
to confirm that the drilled trajectory was ideal. If the
actual trajectory deviated from the ideal trajectory due
to the poor fit between the template and the posterior
atlantoaxial surface, the direction of the drill was ad-
justed according to the template. After achieving the
ideal spiral path, a 3.5-mm screw was inserted. The
pre-bent rods were then secured to the sides of the
atlantoaxial pedicle screws (Fig. 1). Decompression of
the occipital foramen was then performed if necessary.
Postoperative treatment
The patient’s vital signs were closely observed. Post-
operative routine hormones were given to prevent
spinal cord inflammation and edema; antibiotics were
given to prevent infection; meeobalamin was used for
nourishing nerves. The drainage tube was routinely
removed within 48 hours. The patient was routinely
bedridden 3-5 d, with the axis turned over; after 3-5d,
patients would go to the ground. The neck brace was
worn for 3 months after operation, followed by the
X-ray examination of the cervical spine. According to
the results of the review, the neck brace was removed.
Evaluation of outcomes
Evaluation of screw trajectories
The accuracy of the atlantoaxial pedicle screw was
analyzed by a physician who did not participate in sur-
gical stapling. All patients had cervical CT scans after
surgery. Preoperative and postoperative CT images
were imported into Mimics software. The preopera-
tive atlantoaxial 3D model and cylinder as well as the
postoperative atlantoaxial 3D model and screw were
reconstructed. The "global registration" operation was
used to superimpose the preoperative 3D model with
the cylinder and the postoperative 3D model with the
screw. This overlay facilitated the comparison of the
Yong-xiong He et al 5
Clin Surg Res Commun 2018; 2(4): 1-10
placed in a direction that was adjusted during surgery,
and a satisfactory screw trajectory was achieved after
adjustment. No complications such as vertebral artery
injury, cerebrospinal fluid leakage or spinal cord injury
were found. Three patients developed venous plexus
hemorrhage. The mean operative time was 174.3 ±
27.6 minutes and the mean bleeding volume was 312.9
± 13.5 ml. The mean frequency of intraoperative fluo-
roscopy was 2.60 ± 0.68.
Comparison of JOA scores before and after
surgery
The scores of the Japanese Orthopaedic Association
(JOA) were compared between pre-surgery and 6
months after surgery. The preoperative JOA score was
12.45 ± 1.15 and postoperative JOA score was 15.5 ±
0.89, with statistically significant difference (P < 0.05)
(Fig. 2).
Comparisons between the ideal and actual
screw trajectories, entry points
A total of 80 atlantoaxial pedicle screws were placed
in 20 AAI patients. Postoperative CT scan showed
79 grade 0 screws and 1 grade I screw. One of the
pivotal screws deviated inwardly from the pedicle
cortex and entered the spinal canal approximately 1
mm, but no neurological and surgical complications
occurred. There was no significant difference in the
mean cross-sectional angle between the left (P = 0.45),
right (P = 0.79) ideal screw trajectory and actual
screw trajectory of atlas. No significant difference in
the mean sagittal angle was observed between the left
(P = 0.30), right (P = 0.10) ideal screw trajectory and
the actual screw trajectory of atlas (Table 1 and Fig.
3A). Besides, there was no significant difference in the
mean cross-sectional angle between the left (P = 0.39),
right (P = 0.11) ideal screw trajectory and actual screw
trajectory of axis. No significant difference in the mean
sagittal angle was observed between the left (P = 0.17),
right (P = 0.33) ideal screw trajectory and the actual
screw trajectory of axis (Table 2 and Fig.3B). As for the
screw entry point coordinates, there was no signifi-
cant difference between the ideal entry point and the
actual entry point on both sides of the atlases, axises (P
> 0.05) (Table 3 and Table 4).
Comparison between bare-handed or naviga-
tion module-assisted screw-setting in previ-
ous study [17]
and navigation module-assisted
screw-setting in our study
DOI: 10.31491/CSRC.2018.12.023
Figure 3. Comparison of the angle between the ideal and actual screw trajectory in (A) C1 and (B) C2. ls, lateral section; sp,
sagittal plane.
Figure 2. Schematic diagram of JOA scores before
and after surgery. *P < 0.05.
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Yong-xiong He et al 6
In our study, using navigation module-assisted
screw-setting, 40 screws were placed in the atlas with
40 screws of grade 0 (100%) and 40 screws were
placed in the axis with 39 screws of grade 0 (97.5%)
and 1 screw of grade I (2.5%).
In the reference [17]
, using bare-handed screw-setting,
44 screws were placed in the atlas, with 21 screws
of grade 0 (47.7%), 17 screws of grade I (38.6%), 4
screws of grade II (9.14%), and 2 screws of grade III
(4.5%); using navigation module-assisted screw-set-
ting, a total of 38 screws were placed with 35 screws
of grade 0 (92. 1%) and 3 screws of grade I (7.9%).
In our study, grade 0 and grade I screws were consid-
ered as satisfactory screws. The satisfaction rate of
atlantoaxial screw placement in this study was 100%
(40/40; 40/40). In the reference [17]
, the satisfaction
rate was 86. 3% (38/44) for bare-handed screw-set-
ting and was 100% (38/38) for navigation module-as-
sisted screw-setting.
Using the rank sum test analysis, the accuracy of
screw-setting was significantly improved in our study
compared with the bare-handed screw-setting group
of the reference (P < 0.01). Further, there was no sig-
nificant difference in the accuracy of navigation mod-
ule-assisted screw-setting between our study and the
reference (P > 0.05)(Tables 5 and 6).
Comparison of postoperative general results
between the previous study [17]
and our study
The average operation time of our study was 174.3
± 27.6 min, with the average blood loss of 312.9 ±
13.5ml. Referring to the previous literature [17]
, for
bare-handed screw-setting and navigation module-as-
sisted screw-setting, the average operation time was
175 ± 41 min and 175 ± 41 min with the average blood
loss of 407 ± 116 ml and 428 ± 104 ml, respective-
ly. Since there was no detailed data in the reference,
simple comparisons can only be made with mean ±
standard deviation. The average operation time of this
study was similar to that of the reference, but the aver-
age amount of bleeding was slightly reduced (Fig. 4A
and B).
Finally, typical cases and special cases were shown in
supplementary Fig. 1.
DISCUSSION
Cervical pedicle screw placement is a difficult point
in spinal surgery. This is related to the particularity of
the atlantoaxial anatomy, which also leads to the risk
of surgery under normal anatomy, and surgery is more
challenging when fractures and dislocations occur in
this area [21]
. Therefore, clinically, atlantoaxial fixation
is difficult and has a high potential risk, and it has been
called a surgical "forbidden zone". CAD-RP technology
can accurately control the patient's anatomy and indi-
vidual differences before surgery, thus improving the
accuracy of atlantoaxial screw-setting. Jiang et al. [22]
used 3D navigation modules to assist the placement
of 128 atlantoaxial pedicle screws in 32 patients with
AAI. Postoperative CT showed that the atlas had two
screws protruding into the spinal canal < 1mm without
causing related complications. Although the anatomi-
cal structure of the lower cervical vertebra is not more
specific than the atlantoaxial vertebrae, it is one of the
difficult factors for screw placement due to individual
differences and damage [23-25]
. In addition, Kaneyamade
et al. [26]
applied a 3D navigation module to assist the
placement of 80 screws in the lower cervical spines of
20 patients; after surgery, all 80 screws were found in
the pedicle without related complications.
In the present study, the guide template of this study
also selects the type of single-vertebral double-sided
Screw
trajectory
C1 left (°) C1 right (°)
Cross-sectional angle Sagittal angle Cross-sectional angle Sagittal angle
Ideal trajectory 7.92 ± 2.37 7.75 ± 0.81 8.59 ± 0.70 8.70 ± 1.05
Actual trajectory 7.82 ± 1.85 8.02 ± 0.55 8.51 ± 0.71 8.36 ± 1.11
P 0.45 0.30 0.79 0.10
Screw
trajectory
C2 left (°) C2 right (°)
Cross-sectional angle Sagittal angle Cross-sectional angle Sagittal angle
Ideal trajectory 23.68 ± 3.62 25.59 ± 1.62 22.82 ± 1.46 24.57 ± 1.33
Actual trajectory 24.59 ± 3.86 25.42 ± 1.55 21.93 ± 1.67 25.07 ± 1.86
P 0.39 0.17 0.11 0.33
Table 1 Comparison of the angle between the ideal and actual screw trajectory in C1.
Table 2 Comparison of the angle between the ideal and actual screw trajectory in C2.
Yong-xiong He et al 7
Clin Surg Res Commun 2018; 2(4): 1-10
DOI: 10.31491/CSRC.2018.12.023
drilling guide plate which is currently used more. This
type of drilling guide plate can select the spinous pro-
cess as a fixed site and has double-sided drilling guide
plate, which can be well fixed during operation. The
drill guide has the advantage of drilling direction, and
intuitively presents the direction of the screw. If neces-
sary, it can help to adjust the direction of the screw. We
found that a screw of the vertebral pedicle deviated in-
wardly from the pedicle cortex and entered the spinal
canal approximately 1 mm, but there was no symptom.
This deviation may be caused by the failure to remove
the soft tissue during surgery, possibly resulting in
insufficient fit between the template and the posterior
vertebral surface. Therefore, the soft tissue on the pos-
terior arch surface of the atlas should be completely
removed before applying the drill guide template. In
previous studies, the efficacy of spinal screw place-
ment was demonstrated in a bilateral guide template.
In the cadaveric study, Hu et al. [27]
placed 64 C1 pedicle
screws and 64 C2 pedicle screws without causing a
screw to penetrate the cortex. However, it should be
noted that the subject is a cadaver. The factors that may
affect the results are listed as follows: preoperative and
postoperative CT scans can be consistent in position;
during the operation, the exposure and peeling of the
operation area can be revealed and peeled off as much
as possible.
Regarding the assessment of screw placement accu-
racy, some studies have simply reported the extent of
screw insertion into the spinal canal in postoperative
CT scans [28]
. In this study, we also made more accurate
evaluation criteria in addition to the statistics of the
degree of screw insertion into the spinal canal. After
using the 3D navigation module to assist the placement
of the screw, the CT scan was first performed on the
postoperative patients. The high-quality rate of the
screw-setting was evaluated by the method developed
by Yoshiharu et al. [18]
. A total of 80 individual screws
were placed in the personalized navigation template
group, of which 79 were grade 0 and 1 was grade I,
with the screw-setting satisfaction rate was 100%. Al-
though this CT scan-based method helps to make the
overall evaluation of the screw position, it cannot help
to effectively compare the ideal and actual trajectories
of the screw. Hu et al. [27]
analyzed the positional devi-
ation of C2 laminar screws from the ideal and actual
entry points as well as trajectory directions. Hu et al.
superimposed the preoperative and postoperative at-
lantoaxial models in Mimics software and compared
the ideal and actual screw trajectories. This is a more
Figure 4. Comparison of the (A) mean blood loss volume and (B) mean operation time between the three groups.
Entry point C1 left (°) C1 right (°)
X Y Z X Y Z
Ideal point 25.59 ± 1.63 30.70 ± 0.97 0.49 ± 0.73 -15.02 ± 0.74 32.06 ± 1.07 0.01 ± 0.47
Actual point 25.42 ± 1.55 31.36 ± 1.12 0.55 ± 0.15 -15.24 ± 0.80 31.67 ± 1.09 0.23 ± 0.57
P 0.78 0.13 0.19 0.30 0.23 0.18
Table 3 Comparison of the ideal entry point and actual entry point in C1.
x, coronal axis; y, sagittal axis; z, vertical axis.
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Yong-xiong He et al 8
efficient way to compare the ideal and actual screw
trajectories. In this study we also used this method to
compare the ideal and actual screw trajectories. The
results showed that the application of the drill guide
module to assist the placement of the pedicle screw
was extremely accurate, and there was no statistical
difference between the two screw trajectories. The
evaluation of the two screw trajectories can not only
overall reflects the satisfaction rate of screw-setting,
but also analyzes the ideal and actual screw trajectory
angles in different planes, making the evaluation of
screw-setting accuracy more perfect.
The average operation time in this study was similar
to that in the previous study [17]
. However, the average
blood loss of this study was significantly lower than
that in the reference [17]
, possibly due to the following
points. First, there were differences in the number of
experimental subjects: 20 subjects in this study, 22
cases in the bare-handed screw-setting group of the
reference, and 19 cases in the navigation module-
assisted screw-setting group of the reference. Second,
the differences in the intraoperative situation and
the patient's own situation. The age of patients in our
study was significantly different from the overall age
of the reference. The maximum age of the experiment
was 46 years, and the maximum age of the reference
was 64 years. Finally, intraoperative application of
devices and personal operating habits may also be the
cause. Besides, we found that the amount of bleeding
in the navigation module-assisted screw-setting group
was higher than that in the bare-handed screw-setting
group [17]
, possibly resulting from the pursuit of the
fitting degree of the guide to increase the extent of
the vision field and soft tissue peeling during the use
of guide templates. We believe that when using 3D
navigation templates, we should combine the actual
situation in the operation, and reduce the degree of
peeling as much as possible without affecting the
accuracy of screw placement.
During the operation of this study, it was found that
the texture of the material used in the navigation
template, a photosensitive resin material, was rela-
tively soft and slight deformation occurred during
use, which may be one of the causes of errors in this
experiment. Owing to the diversity of materials of 3D
printing technology, metal materials would be used
to make navigation templates in the subsequent sur-
geries, which may eliminate related problems in this
study. Besides, considering that the operating rooms of
most lower-level hospitals may not be equipped with
plasma disinfection equipment, the upgraded mate-
rials can also be used in the operating room without
plasma disinfection equipment, which is conducive to
clinical promotion. Further, in the early stage of the
surgery, the surgeon with relatively lack of experience
was selected for operation, resulting in a decrease in
the satisfaction rate of the screw-setting. The postop-
erative X-ray film clearly showed the screw offset, but
no neurological complications. Therefore, we believe
that 3D navigation template-assisted screw-setting can
greatly improve the accuracy of screw placement, but it
is not omnipotent. This method still requires the oper-
ation of a physician with certain experience, and there
is also a certain requirement for the understanding and
Groups No. of screws Grade 0 Grade I Grade II Grade III
Bare-handed screw-setting in
previous study [52]
44 21 17 4 2
Navigation-assisted screw-setting
in our study
40 40 0 0 0
Z 420
P < 0.01
Table 5 Comparison of the accuracy between bare-handed screw-setting in previous study [52]
and navigation mod-
ule-assisted screw-setting in our study.
Entry point C2 left (°) C2 right (°)
X Y Z X Y Z
Ideal point 19.22 ± 0.71 22.70 ± 1.57 -2.28 ± 0.61 -19.38 ± 0.78 -19.38 ± 0.78 -2.02 ± 0.48
Actual point 19.34 ± 1.07 22.35 ± 0.98 -2.40 ± 0.55 -19.28 ± 0.88 -19.28 ± 0.87 -2.22 ± 0.64
P 0.19 0.31 0.55 0.17 0.16 0.33
Table 4 Comparison of the ideal entry point and actual entry point in C2.
x, coronal axis; y, sagittal axis; z, vertical axis.
Yong-xiong He et al 9
Clin Surg Res Commun 2018; 2(4): 1-10
DOI: 10.31491/CSRC.2018.12.023
proficiency of the use of the guide in case of emergen-
cy. However, the guide template is still positive for the
guidance of young physicians, which can greatly reduce
the learning curve and improve the accuracy of screw
placement.
After this stage of surgery accumulation, we have two
thoughts on the 3D navigation module. First of all, most
of the currently used navigation module materials are
photosensitive resin materials. In this study, the prob-
lems caused by the disinfection and use of materials
have highlighted the limitation of the 3D navigation
module itself. We consider further optimized materials
as metal 3D navigation modules. Secondly, we encoun-
tered a deviation in the use of navigation templates due
to poor chimerism, affecting the accuracy and safety of
the screw placement. We believe that if the guide rod of
the external screw-setting angle can be added during
the production of the navigation template, the accura-
cy and safety of the screw-setting may be further im-
proved. When a similar problem is encountered, even if
the navigation template is not well fitted, the guide rod
can still guide the screw placement.
In conclusion, the use of 3D navigation module is safe
and effective for atlantoaxial pedicle screw implanta-
tion, which can significantly improve the accuracy of
screw placement and prevent surgical complications.
Therefore, the 3D navigation module-assisted posterior
atlantoaxial fixation is worthy of clinical application.
Acknowledgement
This study was supported by Major project of Science
and Technology department of Inner Mongolia autono-
mous region (No. kjt14gx20).
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Clinical application and efficacy analysis of 3 d navigation module in the treatment of atlantoaxial instability

  • 1. ClinicalApplication and EfficacyAnalysis of 3D Navigation Module in the Treatment ofAtlantoaxial Instability Research article Clin Surg Res Commun 2018; 2(4): 1-10 DOI: 10.31491/CSRC.2018.12.023 Yong-xiong He et al 1 Bo-kang Lv a,# , Xing Wangb,# , Erbin Ab , Fei Gaob , Yan-qiang Huanc , Le-meng Chaoc , Jian-feng Liuc , Fei Wangc , Yong-xiong Hec, *, and Bin Liud, * Abstract Background: Posterior cervical atlantoaxial pedicle screw fixation is a very effective treatment for atlantoaxial instability (AAI). However, due to the complex anatomy of the cranial-cervical junction, the accuracy and safety of posterior atlantoaxial pedicle screw placement remains extremely challenging. Objective: To quantitatively evaluate the safety and accuracy of the 3D navigation module to assist the posterior atlantoaxial fixation. Methods: A total of 20 AAI patients were selected between June 2014 and September 2015. The Mimics v10.1 and 3-matic software were used. The 3D navigation module was designed as a double-sided positioning hole guide with a guide rod. All patients underwent posterior atlantoaxial posterior pedicle screw fixation with 3D navigation module. The actual entry point and screw trajectory were measured after operation, which were compared with the ideal entry point and screw trajectory. The Japanese Orthopaedic Association (JOA) score was measured before and after surgery to evaluate the neurological function improvement. The average operation time, blood loss, and frequency of intraoperative fluoroscopy were counted. Results: The posterior atlantoaxial pedicle screw fixation with a 3D navigation module was successfully performed in all patients. A total of 80 atlantoaxial pedicle screws were implanted in the 20 patients. Postoperative CT scan showed that two pedicle screws deviated from the medial aspect of the atlas pedicle cortex and entered the spinal canal approximately 1 mm, without causing neurological complications. There was no significant difference between the ideal and actual entry points or ideal and actual screw trajectories of the atlas and axis (P > 0.05). The preoperative JOA score was 12.45 ± 1.15 and postoperative JOA score was 15.5 ± 0.89, with statistically significant difference (P < 0.05). Conclusion: It was safe and effective to use the 3D navigation module to assist the posterior atlantoaxial pedicle insertion, with a high accuracy of pedicle screw placement. Keywords: atlantoaxial instability; pedicle screw; 3D navigation module; rapid prototyping # These authors contributed equally to this work. *Corresponding author: Yong-xiong He Mailing address: Department of Spine Surgery, Inner Mongolia People’s Hospital, Saihan District Zhao wuda road No.42, Hohhot 010017, Inner Mongolia, China. E-mail: spinedoctor@sina.com Tel: +86-0471-2243347 *Corresponding author: Bin Liu Mailing address: Inner Mongolia Medical University, Hohhot 010110 Inner Mongolia, China. E-mail: blnm@sina.com Received: 15 November 2018 Accepted: 15 December 2018 atlantoaxial pedicle screw fixation [1-3] . The cervical spondylosis requiring internal fixation was generally caused by multiple injuries and such injuries were often combined with fracture dislocation, leading to the destruction of its three-column structure. In 1994, Abumi, et al. [4] successfully applied and promoted the posterior cervical pedicle screw fixation in the treatment of lower cervical injury. Because the pedicle screw fixed the three columns (anterior, median, and posterior) of the vertebral body and thus provided a good three-dimensional fixed pattern, it has obvious advantages compared with other fixed methods by biomechanics [5] . However, as the cervical vertebra has a complex anatomical structure and an important adja- cent relationship, and the pedicle is relatively slender INTRODUCTION In recent years, patients with atlantoaxial instabili- ty (AAI) have been routinely treated with posterior a Zhengzhou University fifth affiliated hospital 450000, henan province , China. b Department of Spine Surgery, Bayannaoer Hospital, Linhe 015000, Inner Mongolia, China. c Department of Spine Surgery, Inner Mongolia People’s Hospital, Hohhot 010017 Inner Mongolia, China. d Inner Mongolia Medical University, Hohhot 010110 Inner Mongolia, China. Creative Commons 4.0
  • 2. Published online: 25 December 2018 ANT PUBLISHING CORPORATION Yong-xiong He et al 2 with great angle change, the most common and most serious surgical complications are C2 nerve root and vertebral artery injures that are caused by the pedicle screw trajectories deviating from the pedicle cortex [6] , which makes the clinical application of posterior cervi- cal pedicle screw fixation extremely limited. Therefore, how to improve the accuracy of screw placement and reduce surgical complications is an important problem that needs to be solved urgently in clinical work. The cervical pedicle screw fixation methods currently used in the clinic include bare-handed screw-setting [7] , screw-setting assisted by the imaging techniques, computer-assisted orthopaedics surgery (CAOS) [8] , and 3D printing technology that was also called comput- er-aided design-rapid prototyping (CAD-RP technolo- gy). The key points of the bare-handed screw-setting are the accuracy of the point and direction of the screw, rich experience, and intraoperative fluoroscopy. The screw-setting assisted by the imaging techniques has high requirements for doctors' knowledge accumu- lation, experience judgment, and spatial imagination, causing certain subjectivity and lacking objective mea- surement standards. CAOS makes intraoperative sur- gery more precise, safe and effective, but its expensive equipment costs and operational complexity limit its promotion and application [9-11] . The CAD-RP technique was first applied to lumbar pedicle screw placement by Radermacher et al. [12] . It is a kind of modern digital orthopedic technology. Its principle is to scan the struc- ture of tissue and organ through CT, generate a propor- tional 3D module corresponding to the real object, and make a solid model proportional to the patient through the 3D printer; through the solid model, the surgical simulation and intraoperative reference and appli- cation are performed [10] . The rapid prototyping drill guide template designed by 3D printing technology can help improve the accuracy of the screw placement [13-16] . In this prospective clinical study, we designed a drill guide template for atlantoaxial pedicle screw place- ment. The purpose of this study was to quantitatively evaluate the accuracy of placement of atlantoaxial ped- icle screws using a drill guide template. MATERIALS AND METHODS Subjects All patients signed written informed consent. In ad- dition, this study followed the principles outlined in the Helsinki Declaration. Patients with atlantoaxial instability (AAI) who were hospitalized and surgically treated in our hospital from June 2014 to September 2015 were enrolled in this prospective study. A total of 20 patients who underwent AAI posterior approach (17 Male and 3 female), with an average age of 42.6 years (age range 22-46 years), were selected based on the inclusion and exclusion criteria. All AAI patients underwent posterior atlantoaxial pedicle screw fixa- tion with a drill guide template. All protocols have been approved by the Committee of Inner Mongolia People’s Hospital. Diagnostic criteria: All patients were diagnosed with AAI by clinical and imaging examinations and had clini- Figure 1. A. The atlantoaxial and drilling guides produced by Mimics software. B. Atlantoaxial models and drilling guides generated using rapid prototyping techniques. C. 3D module disinfection backup and 3D module placed on the spinous process of the axon. D. The accurate internal fixation showed by postoperative X-ray.
  • 3. Yong-xiong He et al 3 Clin Surg Res Commun 2018; 2(4): 1-10 cal symptoms. Inclusion criteria: patients who meet the diagnostic criteria; patients who can be placed with the atlantoax- ial pedicle screw by X-ray, computed tomography (CT), and magnetic resonance imaging (MRI) examinations; patients whose surgeries were performed by the same senior physician. Exclusion criteria: patients with severe vertebral injury, malformation, small posterior arch, etc.; patients with advanced age, combined with serious medical diseases and osteoporosis, unable to tolerate surgery; patients with infection, tuberculosis, tumor, and other complica- tions; patients who had a mental illness. Construction of 3D navigation module Software Platform Mimics (Materialise's interactive medical image con- trol system), known as "Dream Factory of Medical Imaging", is a medical image control system developed by Materialise of Belgium to realize interoperability. Through this software, various medical imaging mate- rials such as CT, MRI, and other two-dimensional data are imported, and then the image data are analyzed by the clinician on three different orthogonal planes: cross-section, coronal plane, and sagittal plane. The valuable areas are optimized to get the desired data, and then the 3D data model is rebuilt. Through the sur- gical simulation operation, virtual surgical operations can be performed in the software, such as pre-surgical program and prosthesis placement. Mimics can per- form 3D reconstruction of imaging data, providing sup- port for a variety of supporting software applications such as virtual reality (VR), computer-aided design (CAD), finite element analysis (FEA), and rapid proto- typing (RP). Therefore, Mimics can be used for clinical diagnosis, surgical simulation (pre-surgical program, virtual surgery operation, prediction and analysis of surgical risk), and can also be applied to anatomy teaching and scientific research. It has great potential for functional development [17] . 3-matic is a forward engineering based on Digital Standard Triangle Language (STL) produced by Ma- terialise. It can directly edit and modify STL format files to implement FEA/CFD processing in various STL formats. All operations of 3-matic are based on digital form (triangle based) for stretching, rotation, array- ing, etc. It can directly copy and paste the anatomical data in Mimics software, and can input them into any CAD document. Through 3-matic, we can implement 3D measurement and engineering analysis, design implants and surgical guidelines for specific patient surgeries, and prepare anatomical data or implants for finite element simulations. This study used 3-matic to create a personalized navigation template for atlanto- axial pedicles, which greatly reduced the time required to create navigation templates using traditional reverse engineering [17] . Atlantoaxial pedicle screw simulation placement All patients underwent cervical CT with a tomographic thickness of 0.625 mm. CT images were imported into Mimics software and the atlantoscopic 3D model was constructed. In the virtual environment of the Mimics software, a cylinder (3.5 mm in diameter) was created as an atlantoaxial pedicle screw, which is because it is easier to make and adjust the position of the cylinder in the software. The ideal trajectory of the atlantoaxial pedicle screw was created and adjusted by directly ob- serving the relationship between the cylinder and the pedicle cortical bone in different planes. Production of atlantoaxial 3D guide module Then the 3D model of the atlantoaxial vertebral body and the cylinder was introduced into the 3-matic (Ma- terialise) software to design a 3D drilling guide module with drilling guidance. In the 3-matic software, the sur- face of the template (2.5-mm thickness) was created as the opposite side of the posterior atlantoaxial surface, thus providing a perfect fit between the template and the posterior atlantoaxial surface. Using a Boolean sub- traction operation, two position holes (3.5-mm diame- ter) were created on both sides of the template surface based on the data of the cylinder. After the cylinder was interactively translated, two guide holes (3.5-mm di- ameter) were created on the optimum entry points on either side of the template surface. The direction of the drill guide hole was exactly the same as the optimum nailing direction. The local Boolean operation was used to combine the drill guide hole and the template sur- face with the positioning hole into one unit . Physical molding of 3D guides The DICOM format of the cervical CT of the patient was introduced into the Mimics software, and the at- las template of interest was obtained by operation of thresholding, region growing, crop mask, editing mask, etc. Then the atlas template selected, followed by the click of the “Calculate 3D” button to complete the 3D reconstruction of the atlas. The 3D model of the atlas was displayed in the 3D viewport and was smoothed, reduced by triangle reduction, etc. The final 3D model of the atlas was obtained, and then imported into a 3D printer to print out the patient’s atlantoaxial model us- ing a photosensitive resin material. Surgical procedures DOI: 10.31491/CSRC.2018.12.023
  • 4. ANT PUBLISHING CORPORATION Published online: 25 December 2018 Yong-xiong He et al 4 cross-sectional angle and sagittal angle between the ideal screw trajectory with the actual screw trajecto- ry. Besides, the patient was routinely examined by CT after surgery, and the picture archiving and commu- nication system (PACS) measurement tool was used to display the relative positional relationship between the screw and the pedicle according to the CT slice. Screw-setting accuracy was evaluated by the methods provided by Yoshiharu et al. [18] , Miyamoto et al. [19] , and Yasutsugu et al. [20] . Grade 0: The screw is completely placed inside the pedicle; Grade I: the screw penetrates the pedicle bone cortex ≤ 2 mm, without neurological or vertebral artery injury and other complications associated with screw placement; Grade II: screw penetrates the pedicle bone cortex> 2mm, without neurological or vertebral artery injury and other com- plications related to nailing; Grade III: neurological or vertebral artery injury and other complications related to screw placement occur. Evaluation of the entry points In order to properly compare the ideal and actual coordinates of the entry point, the axis of the atlanto- axial axis was adjusted. For C1, the front nodule was treated as the origin of the coordinate axis. The x-axis passed through the origin of the coronal plane and was parallel to the line connecting the lowest points of the lower articular processes on both sides. The y-axis and the z-axis passed through the origin and were per- pendicular to the x-axis of the horizontal and coronal planes, respectively. In the case of the C2 vertebra, the midpoint of the line connecting the lowest points of the articular processes on both sides was regarded as the origin. The y-axis and the z-axis passed through the origin and were perpendicular to the x-axis of the hori- zontal and coronal planes, respectively. Evaluation of neurological function improvement The JOA score was used to evaluate the neurological function of the patient before and 6 months after sur- gery. The score was divided into 17 points. The higher the score, the better the neurological function. Statistical analysis Statistical analysis was performed using SPSS 13.0 statistical software. Data were expressed as mean ± standard deviation. The comparisons were performed using paired-sample t-test. P < 0.05 was considered as significantly different. RESULTS Statistics of postoperative general results All patients successfully underwent surgery with the aid of a drill guide template. Five of the 80 screws were All operations were performed by the same senior surgeon. The patient was placed in the prone position under general anesthesia and the head was fixed by the Mayfield head frame. The median incision of the pos- terior neck was taken and separated layer by layer to fully reveal the posterior structure of the atlantoaxial vertebrae, including the posterior tibial tuberosity and posterior arch, lamina, and lateral vertebral blocks. The soft tissue covering the bony structure was completely peeled off by subperiosteal peeling to make the drill guide template to be fully compatible with the posteri- or surface of the vertebra. The drill guide was fixed and the guide hole was drilled through the template posi- tioning hole, followed by the drilling of the trajectory parallel to the guide rod of the template. The probe was used to detect the four walls of the nailing channel were leaking. The intraoperative fluoroscopy was used to confirm that the drilled trajectory was ideal. If the actual trajectory deviated from the ideal trajectory due to the poor fit between the template and the posterior atlantoaxial surface, the direction of the drill was ad- justed according to the template. After achieving the ideal spiral path, a 3.5-mm screw was inserted. The pre-bent rods were then secured to the sides of the atlantoaxial pedicle screws (Fig. 1). Decompression of the occipital foramen was then performed if necessary. Postoperative treatment The patient’s vital signs were closely observed. Post- operative routine hormones were given to prevent spinal cord inflammation and edema; antibiotics were given to prevent infection; meeobalamin was used for nourishing nerves. The drainage tube was routinely removed within 48 hours. The patient was routinely bedridden 3-5 d, with the axis turned over; after 3-5d, patients would go to the ground. The neck brace was worn for 3 months after operation, followed by the X-ray examination of the cervical spine. According to the results of the review, the neck brace was removed. Evaluation of outcomes Evaluation of screw trajectories The accuracy of the atlantoaxial pedicle screw was analyzed by a physician who did not participate in sur- gical stapling. All patients had cervical CT scans after surgery. Preoperative and postoperative CT images were imported into Mimics software. The preopera- tive atlantoaxial 3D model and cylinder as well as the postoperative atlantoaxial 3D model and screw were reconstructed. The "global registration" operation was used to superimpose the preoperative 3D model with the cylinder and the postoperative 3D model with the screw. This overlay facilitated the comparison of the
  • 5. Yong-xiong He et al 5 Clin Surg Res Commun 2018; 2(4): 1-10 placed in a direction that was adjusted during surgery, and a satisfactory screw trajectory was achieved after adjustment. No complications such as vertebral artery injury, cerebrospinal fluid leakage or spinal cord injury were found. Three patients developed venous plexus hemorrhage. The mean operative time was 174.3 ± 27.6 minutes and the mean bleeding volume was 312.9 ± 13.5 ml. The mean frequency of intraoperative fluo- roscopy was 2.60 ± 0.68. Comparison of JOA scores before and after surgery The scores of the Japanese Orthopaedic Association (JOA) were compared between pre-surgery and 6 months after surgery. The preoperative JOA score was 12.45 ± 1.15 and postoperative JOA score was 15.5 ± 0.89, with statistically significant difference (P < 0.05) (Fig. 2). Comparisons between the ideal and actual screw trajectories, entry points A total of 80 atlantoaxial pedicle screws were placed in 20 AAI patients. Postoperative CT scan showed 79 grade 0 screws and 1 grade I screw. One of the pivotal screws deviated inwardly from the pedicle cortex and entered the spinal canal approximately 1 mm, but no neurological and surgical complications occurred. There was no significant difference in the mean cross-sectional angle between the left (P = 0.45), right (P = 0.79) ideal screw trajectory and actual screw trajectory of atlas. No significant difference in the mean sagittal angle was observed between the left (P = 0.30), right (P = 0.10) ideal screw trajectory and the actual screw trajectory of atlas (Table 1 and Fig. 3A). Besides, there was no significant difference in the mean cross-sectional angle between the left (P = 0.39), right (P = 0.11) ideal screw trajectory and actual screw trajectory of axis. No significant difference in the mean sagittal angle was observed between the left (P = 0.17), right (P = 0.33) ideal screw trajectory and the actual screw trajectory of axis (Table 2 and Fig.3B). As for the screw entry point coordinates, there was no signifi- cant difference between the ideal entry point and the actual entry point on both sides of the atlases, axises (P > 0.05) (Table 3 and Table 4). Comparison between bare-handed or naviga- tion module-assisted screw-setting in previ- ous study [17] and navigation module-assisted screw-setting in our study DOI: 10.31491/CSRC.2018.12.023 Figure 3. Comparison of the angle between the ideal and actual screw trajectory in (A) C1 and (B) C2. ls, lateral section; sp, sagittal plane. Figure 2. Schematic diagram of JOA scores before and after surgery. *P < 0.05.
  • 6. ANT PUBLISHING CORPORATION Published online: 25 December 2018 Yong-xiong He et al 6 In our study, using navigation module-assisted screw-setting, 40 screws were placed in the atlas with 40 screws of grade 0 (100%) and 40 screws were placed in the axis with 39 screws of grade 0 (97.5%) and 1 screw of grade I (2.5%). In the reference [17] , using bare-handed screw-setting, 44 screws were placed in the atlas, with 21 screws of grade 0 (47.7%), 17 screws of grade I (38.6%), 4 screws of grade II (9.14%), and 2 screws of grade III (4.5%); using navigation module-assisted screw-set- ting, a total of 38 screws were placed with 35 screws of grade 0 (92. 1%) and 3 screws of grade I (7.9%). In our study, grade 0 and grade I screws were consid- ered as satisfactory screws. The satisfaction rate of atlantoaxial screw placement in this study was 100% (40/40; 40/40). In the reference [17] , the satisfaction rate was 86. 3% (38/44) for bare-handed screw-set- ting and was 100% (38/38) for navigation module-as- sisted screw-setting. Using the rank sum test analysis, the accuracy of screw-setting was significantly improved in our study compared with the bare-handed screw-setting group of the reference (P < 0.01). Further, there was no sig- nificant difference in the accuracy of navigation mod- ule-assisted screw-setting between our study and the reference (P > 0.05)(Tables 5 and 6). Comparison of postoperative general results between the previous study [17] and our study The average operation time of our study was 174.3 ± 27.6 min, with the average blood loss of 312.9 ± 13.5ml. Referring to the previous literature [17] , for bare-handed screw-setting and navigation module-as- sisted screw-setting, the average operation time was 175 ± 41 min and 175 ± 41 min with the average blood loss of 407 ± 116 ml and 428 ± 104 ml, respective- ly. Since there was no detailed data in the reference, simple comparisons can only be made with mean ± standard deviation. The average operation time of this study was similar to that of the reference, but the aver- age amount of bleeding was slightly reduced (Fig. 4A and B). Finally, typical cases and special cases were shown in supplementary Fig. 1. DISCUSSION Cervical pedicle screw placement is a difficult point in spinal surgery. This is related to the particularity of the atlantoaxial anatomy, which also leads to the risk of surgery under normal anatomy, and surgery is more challenging when fractures and dislocations occur in this area [21] . Therefore, clinically, atlantoaxial fixation is difficult and has a high potential risk, and it has been called a surgical "forbidden zone". CAD-RP technology can accurately control the patient's anatomy and indi- vidual differences before surgery, thus improving the accuracy of atlantoaxial screw-setting. Jiang et al. [22] used 3D navigation modules to assist the placement of 128 atlantoaxial pedicle screws in 32 patients with AAI. Postoperative CT showed that the atlas had two screws protruding into the spinal canal < 1mm without causing related complications. Although the anatomi- cal structure of the lower cervical vertebra is not more specific than the atlantoaxial vertebrae, it is one of the difficult factors for screw placement due to individual differences and damage [23-25] . In addition, Kaneyamade et al. [26] applied a 3D navigation module to assist the placement of 80 screws in the lower cervical spines of 20 patients; after surgery, all 80 screws were found in the pedicle without related complications. In the present study, the guide template of this study also selects the type of single-vertebral double-sided Screw trajectory C1 left (°) C1 right (°) Cross-sectional angle Sagittal angle Cross-sectional angle Sagittal angle Ideal trajectory 7.92 ± 2.37 7.75 ± 0.81 8.59 ± 0.70 8.70 ± 1.05 Actual trajectory 7.82 ± 1.85 8.02 ± 0.55 8.51 ± 0.71 8.36 ± 1.11 P 0.45 0.30 0.79 0.10 Screw trajectory C2 left (°) C2 right (°) Cross-sectional angle Sagittal angle Cross-sectional angle Sagittal angle Ideal trajectory 23.68 ± 3.62 25.59 ± 1.62 22.82 ± 1.46 24.57 ± 1.33 Actual trajectory 24.59 ± 3.86 25.42 ± 1.55 21.93 ± 1.67 25.07 ± 1.86 P 0.39 0.17 0.11 0.33 Table 1 Comparison of the angle between the ideal and actual screw trajectory in C1. Table 2 Comparison of the angle between the ideal and actual screw trajectory in C2.
  • 7. Yong-xiong He et al 7 Clin Surg Res Commun 2018; 2(4): 1-10 DOI: 10.31491/CSRC.2018.12.023 drilling guide plate which is currently used more. This type of drilling guide plate can select the spinous pro- cess as a fixed site and has double-sided drilling guide plate, which can be well fixed during operation. The drill guide has the advantage of drilling direction, and intuitively presents the direction of the screw. If neces- sary, it can help to adjust the direction of the screw. We found that a screw of the vertebral pedicle deviated in- wardly from the pedicle cortex and entered the spinal canal approximately 1 mm, but there was no symptom. This deviation may be caused by the failure to remove the soft tissue during surgery, possibly resulting in insufficient fit between the template and the posterior vertebral surface. Therefore, the soft tissue on the pos- terior arch surface of the atlas should be completely removed before applying the drill guide template. In previous studies, the efficacy of spinal screw place- ment was demonstrated in a bilateral guide template. In the cadaveric study, Hu et al. [27] placed 64 C1 pedicle screws and 64 C2 pedicle screws without causing a screw to penetrate the cortex. However, it should be noted that the subject is a cadaver. The factors that may affect the results are listed as follows: preoperative and postoperative CT scans can be consistent in position; during the operation, the exposure and peeling of the operation area can be revealed and peeled off as much as possible. Regarding the assessment of screw placement accu- racy, some studies have simply reported the extent of screw insertion into the spinal canal in postoperative CT scans [28] . In this study, we also made more accurate evaluation criteria in addition to the statistics of the degree of screw insertion into the spinal canal. After using the 3D navigation module to assist the placement of the screw, the CT scan was first performed on the postoperative patients. The high-quality rate of the screw-setting was evaluated by the method developed by Yoshiharu et al. [18] . A total of 80 individual screws were placed in the personalized navigation template group, of which 79 were grade 0 and 1 was grade I, with the screw-setting satisfaction rate was 100%. Al- though this CT scan-based method helps to make the overall evaluation of the screw position, it cannot help to effectively compare the ideal and actual trajectories of the screw. Hu et al. [27] analyzed the positional devi- ation of C2 laminar screws from the ideal and actual entry points as well as trajectory directions. Hu et al. superimposed the preoperative and postoperative at- lantoaxial models in Mimics software and compared the ideal and actual screw trajectories. This is a more Figure 4. Comparison of the (A) mean blood loss volume and (B) mean operation time between the three groups. Entry point C1 left (°) C1 right (°) X Y Z X Y Z Ideal point 25.59 ± 1.63 30.70 ± 0.97 0.49 ± 0.73 -15.02 ± 0.74 32.06 ± 1.07 0.01 ± 0.47 Actual point 25.42 ± 1.55 31.36 ± 1.12 0.55 ± 0.15 -15.24 ± 0.80 31.67 ± 1.09 0.23 ± 0.57 P 0.78 0.13 0.19 0.30 0.23 0.18 Table 3 Comparison of the ideal entry point and actual entry point in C1. x, coronal axis; y, sagittal axis; z, vertical axis.
  • 8. ANT PUBLISHING CORPORATION Published online: 25 December 2018 Yong-xiong He et al 8 efficient way to compare the ideal and actual screw trajectories. In this study we also used this method to compare the ideal and actual screw trajectories. The results showed that the application of the drill guide module to assist the placement of the pedicle screw was extremely accurate, and there was no statistical difference between the two screw trajectories. The evaluation of the two screw trajectories can not only overall reflects the satisfaction rate of screw-setting, but also analyzes the ideal and actual screw trajectory angles in different planes, making the evaluation of screw-setting accuracy more perfect. The average operation time in this study was similar to that in the previous study [17] . However, the average blood loss of this study was significantly lower than that in the reference [17] , possibly due to the following points. First, there were differences in the number of experimental subjects: 20 subjects in this study, 22 cases in the bare-handed screw-setting group of the reference, and 19 cases in the navigation module- assisted screw-setting group of the reference. Second, the differences in the intraoperative situation and the patient's own situation. The age of patients in our study was significantly different from the overall age of the reference. The maximum age of the experiment was 46 years, and the maximum age of the reference was 64 years. Finally, intraoperative application of devices and personal operating habits may also be the cause. Besides, we found that the amount of bleeding in the navigation module-assisted screw-setting group was higher than that in the bare-handed screw-setting group [17] , possibly resulting from the pursuit of the fitting degree of the guide to increase the extent of the vision field and soft tissue peeling during the use of guide templates. We believe that when using 3D navigation templates, we should combine the actual situation in the operation, and reduce the degree of peeling as much as possible without affecting the accuracy of screw placement. During the operation of this study, it was found that the texture of the material used in the navigation template, a photosensitive resin material, was rela- tively soft and slight deformation occurred during use, which may be one of the causes of errors in this experiment. Owing to the diversity of materials of 3D printing technology, metal materials would be used to make navigation templates in the subsequent sur- geries, which may eliminate related problems in this study. Besides, considering that the operating rooms of most lower-level hospitals may not be equipped with plasma disinfection equipment, the upgraded mate- rials can also be used in the operating room without plasma disinfection equipment, which is conducive to clinical promotion. Further, in the early stage of the surgery, the surgeon with relatively lack of experience was selected for operation, resulting in a decrease in the satisfaction rate of the screw-setting. The postop- erative X-ray film clearly showed the screw offset, but no neurological complications. Therefore, we believe that 3D navigation template-assisted screw-setting can greatly improve the accuracy of screw placement, but it is not omnipotent. This method still requires the oper- ation of a physician with certain experience, and there is also a certain requirement for the understanding and Groups No. of screws Grade 0 Grade I Grade II Grade III Bare-handed screw-setting in previous study [52] 44 21 17 4 2 Navigation-assisted screw-setting in our study 40 40 0 0 0 Z 420 P < 0.01 Table 5 Comparison of the accuracy between bare-handed screw-setting in previous study [52] and navigation mod- ule-assisted screw-setting in our study. Entry point C2 left (°) C2 right (°) X Y Z X Y Z Ideal point 19.22 ± 0.71 22.70 ± 1.57 -2.28 ± 0.61 -19.38 ± 0.78 -19.38 ± 0.78 -2.02 ± 0.48 Actual point 19.34 ± 1.07 22.35 ± 0.98 -2.40 ± 0.55 -19.28 ± 0.88 -19.28 ± 0.87 -2.22 ± 0.64 P 0.19 0.31 0.55 0.17 0.16 0.33 Table 4 Comparison of the ideal entry point and actual entry point in C2. x, coronal axis; y, sagittal axis; z, vertical axis.
  • 9. Yong-xiong He et al 9 Clin Surg Res Commun 2018; 2(4): 1-10 DOI: 10.31491/CSRC.2018.12.023 proficiency of the use of the guide in case of emergen- cy. However, the guide template is still positive for the guidance of young physicians, which can greatly reduce the learning curve and improve the accuracy of screw placement. After this stage of surgery accumulation, we have two thoughts on the 3D navigation module. First of all, most of the currently used navigation module materials are photosensitive resin materials. In this study, the prob- lems caused by the disinfection and use of materials have highlighted the limitation of the 3D navigation module itself. We consider further optimized materials as metal 3D navigation modules. Secondly, we encoun- tered a deviation in the use of navigation templates due to poor chimerism, affecting the accuracy and safety of the screw placement. We believe that if the guide rod of the external screw-setting angle can be added during the production of the navigation template, the accura- cy and safety of the screw-setting may be further im- proved. When a similar problem is encountered, even if the navigation template is not well fitted, the guide rod can still guide the screw placement. In conclusion, the use of 3D navigation module is safe and effective for atlantoaxial pedicle screw implanta- tion, which can significantly improve the accuracy of screw placement and prevent surgical complications. Therefore, the 3D navigation module-assisted posterior atlantoaxial fixation is worthy of clinical application. Acknowledgement This study was supported by Major project of Science and Technology department of Inner Mongolia autono- mous region (No. kjt14gx20). REFERENCES 1. Mingsheng, T., Huimin, W., Yunting, W., Guangbo, Z., Ping, Y., Zirong, L., Hongyu, W., and Feng, Y. (2003) Morpho- metric evaluation of screw fixation in atlas via posterior arch and lateral mass. Spine 28, 888-895 2. Lee, M. J., Cassinelli, E., and Riew, K. D. (2006) The feasi- bility of inserting atlas lateral mass screws via the poste- rior arch. Spine (Phila Pa 1976) 31, 2798-2801 3. Jin, S. Y., Kafle, D., Nguyen, N. Q., Noh, W., Park, K. W., Chang, B. S., Lee, C. K., and Riew, K. D. (2012) Routine insertion of the lateral mass screw via the posterior arch for C1 fixation: feasibility and related complications. Spine Journal 12, 476-483 4. Abumi, K., Itoh, H., Taneichi, H., and Kaneda, K. (1994) Transpedicular screw fixation for traumatic lesions of the middle and lower cervical spine: description of the techniques and preliminary report. J Spinal Disord 7, 19- 28 5. Ito, Z., Higashino, K., Kato, S., Kim, S. S., Wong, E., Yoshio- ka, K., and Hutton, W. C. (2014) Pedicle screws can be 4 times stronger than lateral mass screws for insertion in the midcervical spine: a biomechanical study on strength of fixation. Clinical Spine Surgery 27, 80-85 6. Gebauer, M., Barvencik, F., Briem, D., Kolb, J. P., Seitz, S., Rueger, J. M., Püschel, K., and Amling, M. (2010) Evalu- ation of anatomic landmarks and safe zones for screw placement in the atlas via the posterior arch. European Spine Journal 19, 85-90 7. Xu, R. (2009) A free-hand technique for pedicle screw placement in the lower cervical spine. Orthopaedic Sur- gery 5, S113-S114 8. Nolte, L. P., and Beutler, T. (2004) Basic principles of CAOS. Injury-international Journal of the Care of the In- jured 35, 6-16 9. Steinmann, J. C., Mirkovic, S., Abitbol, J. J., Massie, J., Sub- baiah, P., and Garfin, S. R. (1990) Radiographic assess- ment of sacral screw placement. Journal of Spinal Disor- ders 3, 232-237 10. Wang, M., and Wand, J. (2005) Application of computer aided navigation orthopedic surgery and medical robot technology in orthopedic trauma. Chinese journal of or- thopedics and traumatology 7, 8-13 11. Laine, T., Lund, T., Ylikoski, M., Lohikoski, J., and Schlenz- ka, D. (2000) Accuracy of pedicle screw insertion with and without computer assistance: a randomised con- trolled clinical study in 100 consecutive patients. Euro- pean Spine Journal 9, 235-240 12. Radermacher, K., Portheine, F., Anton, M., Zimolong, A., Kaspers, G., Rau, G., and Staudte, H. W. (1998) Computer assisted orthopaedic surgery with image based individu- Groups No. of screws Grade 0 Grade I Grade II Grade III Navigation-assisted screw-setting in previous study [17] 35 3 0 0 0 Navigation-assisted screw-setting in our study 40 0 0 0 0 Z 700 P 0.072 Table 6 Comparison of the accuracy of navigation module-assisted screw-setting between the previous study [17] and our study.
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