Eur Spine J
DOI 10.1007/s00586-017-5118-3
ORIGINAL ARTICLE
Application of a novel 3D drill template for cervical pedicle screw
tunnel design: a cadaveric study
Zhengxi Yu2 • Guodong Zhang1 • Xuanhuang Chen2 • Xu Chen2 • Changfu Wu2
Yijun Lin2 • Wenhua Huang1 • Haibin Lin2
Received: 13 April 2016 / Revised: 23 December 2016 / Accepted: 1 May 2017
Ó Springer-Verlag Berlin Heidelberg 2017
Abstract
Purpose To develop and validate the efficacy and accuracy
of a three-dimensional (3D) computed tomography (CT)
reconstructive rapid prototyping drill template for cervical
pedicle screw placement.
Methods CT thin-layer scans were obtained from 12 adult
cadaveric cervical specimens and reconstructed. The ideal
screw channels were chosen by analyzing the cross sections
of the reconstructed 3D images. The navigation templates
were designed and printed based on the optimal screw
channels. The pedicle screws were placed on the cadaver
specimens under template guidance, and the cadaver
specimens were scanned and reconstructed. The pre- and
post-operative models were compared. Entry point and exit
point data of these two models were collected and com-
pared using the Chi-square test.
Results A total of 164 cervical pedicle screws were placed;
among them, six punctured the cortical bone of the verte-
bral pedicle reaching an accuracy of 96.3%. Among the
outside screws, all of the deviation distances were \2 mm.
The Chi-square test results showed that when a deviation of
1.2 mm was used as a standard for the entry point, there
Zhengxi Yu, Guodong Zhang, and Xuanhuang Chen contributed
equally to this study.
& Wenhua Huang
13822232749@139.com
& Haibin Lin
lin@medmail.com.cn
1 relatively high incidence of the screw breaching the ver-
Department of Human Anatomy, Southern Medical
University School of Basic Medical Sciences,
Guangzhou 510515, China
2
Department of Orthopedics, Affiliated Hospital of Putian
College, Putian 351100, China
•
was no difference between the two groups (v2 = 1.346,
p = 0.248); when a deviation of 2.2 mm was used as a
standard for the exit point, there was no difference between
the two groups (v2 = 3.250, p = 0.061).
Conclusion The 3D CT reconstructive rapid prototyping
drill template combined with the screw tunnel design based
on 3D cutting technique can help facilitate accurate cer-
vical pedicle screw insertion.
Keywords Cervical
Pedicle screw
3D prototype

Computer-aided
Digital design
Introduction
Cervical pedicle screws are becoming increasingly popular
during cervical spine fusion surgery because of the better
biomechanics characteristics compared with other instru-
ments for posterior cervical spine fusion surgery. However,
the cervical pedicle screw technique has a relatively high
neural or vascular injury risk due to the anatomical charac-
teristics of the cervical spine and individual differences [1].
The common way to avoid this injury is to use a Kirschner
wire to generate a channel for guiding the pedicle screw.
Traditionally, the surgeon uses their own experience to
choose the entry point and direction of the pedicle screw.
When the screw is inserted into the vertebral pedicle, the
surgeon ensures precise placement using his hand and
sometimes by detecting the hole using a needle. This
method depends on the surgeon’s experience and has a
tebral pedicle. Bydon et al. [2] reviewed 341 C2 pedicle
screw placements using the free hand technique and found
that 59 breached the spinal canal, showing an overall
breach rate of 17.3%. Hojo et al. [3] reviewed a large case
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series containing more than 1000 patients and found that
the overall breach rate was 14.8%. However, in patients
with rheumatoid arthritis, the breach rate was 26.7%. The
traditional method relies on the surgeon’s experience; thus,
it has a long learning curve as well as problems such as low
accuracy, repeated puncture, multiple perspectives, and a
high breach rate. Thus, surgeons should consider individual
differences when using the cervical pedicle screw tech-
nique and create a personalized surgical plan.
Modern medical navigation technology can help the
design and implementation processes, thus significantly
improving pedicle screw placement accuracy and safety
[4–9]. This result was recently confirmed by several studies
in which pedicle screw implementation accuracy was sig-
nificantly improved under different navigation systems
[4, 5, 10]. However, some shortcomings with these systems
persist: (1) the shift can greatly affect accuracy, and these
errors require modification by adding scanning times that
could increase the surgeon’s radiation exposure and pro-
long the operation time [11]; and (2) the navigation system
is too expensive to be used in basic hospitals [12–14].
Several navigation methods based on digital pedicle
screw nail design and template printing have evolved that
reduce the surgeon’s radiation exposure [13, 15–18].
However, these methods are fairly complex and cannot
balance the complex cervical spinal structure and person-
alize schema. Thus, we designed this study to combine the
digital design and 3D printing technique in an effort to
create a personalized navigation system that does not
increase radiation exposure.
Materials and methods
A total of 12 cadaver cervical spine specimens (M: 10, F:
2) were included in this study. All of the specimens were
provided by the local institute. The study protocol was
approved by the Ethics Committee of local College. Soft-
ware and hardware: Dell T7500 workstation (Dell Corpo-
ration, US); Replicator 2 3D printer (Makerbot
Corporation, US); Emotion 16 CT (Siemens Company,
Germany); Mimics 14.0 (Materialise Corporation, Bel-
gium); and Makerware (Makerbot Corporation, US).
Orthopedic appliances: Kirschner (1.2 mm); core drill
(3.5 mm); hollow tap (3.5 mm); industrial stainless steel
countersunk flat head screws (3.5 mm) 20–40 mm, and a
2-mm step into a variety of specifications.
CT scanning condition
Scanning parameters: 130 kV, 21.6 mAs, pitch 0.625 mm;
and a 512 9 512-pixel image in DICOM format through
PACS system output.
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Image editing and 3D reconstruction
The image was input into Mimics 14.0, and a threshold was
set for 120-Maximum Hu, regional growth (Fig. 1a). The
cervical spine was edited (Fig. 1b) and reconstructed into
seven independent vertebrae segmentation masks (Fig. 1c,
d).
Screw tunnel design
C1–2 screw tunnel design
C1 design The 3D-reconstructed C1 vertebra was adjus-
ted in the work station in left view, and the vertebra was
transverse cut in the line connecting these two points: (1)
the midpoint of the shortest line connecting the posterior
arch and the lateral mass; and (2) the midpoint of the
posterior arch. The screw tunnel meets the following
condition:  the thickness of the posterior arch at the entry
point C5.8 mm; ` pass the midpoint of the narrowest part
which connects the posterior arch and the lateral mass; ´
avoiding the vertebral artery and the spinal cord (Fig. 2a–
c).
C2 design essentials In the top view, longitudinal cutting
the center axis of the pedicle, and design the screw tunnel
in the longitudinal section (Fig. 2d–f).
C3–7 screw tunnel design
 Cut the pedicle: use the simulation\cut orthogonal order.
In the upper view, connect the midpoint of the narrowest
line of the vertebral pedicle and 1/3 point of the superior
articular process, pedicle longitudinally following the line
(Fig. 3a). ` Design screw tunnel: use MedCAD\cylinder
order. Arrange the screw tunnel along the center of pedicle
and avoid disturbing the intervertebral disc and small joint.
The nail path was set to 1.3 mm, while the zoom in the nail
path was enlarged to 3.5 mm to see if it wore out the bone
cortex (Fig. 3b). ´ Measure the angle used by the mea-
surements\measure angle order (Fig. 3c).
Design and print the navigation module
Design the navigation module support column using
MedCAD\cylinder order, copy and zoom the screw tunnel to
U10 mm, and adjust it to keep a mini-distance of 35 mm to the
cortical bone. Design the card module using the simulation\cut
orthogonal to screen order. Put the cutting plane squarely to
the operator and cut the posterior spinal structure according to
the stripping range. The area was 2–3 mm to the upper or
lower endplates, 3–4 mm to the cortical bone, and 3–4 mm to
the midpoint of the spinous process. Since this scope has no
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Fig. 1 Image editing. a Regional growth; b three-dimensional (3D) editing; c, d 3D reconstruction

Fig. 2 a Transverse line of the C1 vertebra; b screw tunnel of the C1 vertebral; c left view of the C1 vertebra; d cutting line of the C2 vertebra;
e screw tunnel of the C2 vertebra; f upper view of the C2 vertebra

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Fig. 3 a Cut the pedicle;

b assign the screw tunnel; c cut
the pedicle longitudinally and
measure the angle

Fig. 4 Design of the navigation module. a Cutting bone plane; b Boolean calculation; c navigation module; d modules for C1–C7; e printing
files; f real modules

cartilage, muscle and tendon insertions can be stripped easily
and positioned using the end of the spinous processes as a
localization plane (Fig. 4a). Next, copy the cutting bones, use
simulation\reposition order, and obtain a 5-mm-thick card
module. Use Boolean operations to obtain a prototype of the
navigation module: (card module ? supports column) -
(screw tunnel ? bone on the upper and lower tunnel)
(Fig. 4b). Modify the two models to obtain the final navigation
module (Fig. 4c). All of the navigation modules are shown in
Fig. 4d. The final navigation module was output to makerware
via an STL file. Perform high-precision printing via these files
and create the entity (Fig. 4e, f).

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Fig. 5 Cervical pedicle screw placement under module navigation. a Upper view; b lateral view; c module placement; d break the bone cortex
with nail; e pedicle screw placement; f final result
Module-assisted cervical pedicle screw placement
(1) Screw preparation: choose the optimum pedicle screw
according to the data measured in the mimics. (2) Opera-
tive route: use the posterior approach. (3) Implantation of
the navigation module: the criterion to judge perfect
implantation is to not move when adding pressure to the
module after positioning, and use the other side as a control
and follow the symmetrical rule. (4) Pedicle screw place-
ment: fix the navigation module, drill the Kirschner into the
bone under the navigation of the navigation module, pull
out the navigation module, drill a pedicle tunnel by fol-
lowing the Kirschner, pull out the Kirschner, and place the
screws into the tunnel (Fig. 5a–f).
Three-dimensional registration and data collection
The pre-operative screw tunnel inclination data were col-
lected on the designed module. Post-operative data were
collected on the 3D reconstructed operated cervical spine.
The operated specimens were scanned by thin-slice CT.
The 3D cervical spine model was merged with all of the
pedicle screws via simulation\merge order and put back
into MIMICS using an STL file. The post-operative model
was matched with the pre-operative design model via
registration\point and global registration order (Fig. 6).
The post-operative model was split into bones and
screws using the simulation\split order. The post-operative
screw tunnels were built via the MedCAD\cylinder order
along the long axis of the pedicle screws. The pre-operative
and post-operative screw tunnels were set to U0.02 mm,
while the entry and exit points of the screw tunnels were
built via MedCAD\point order. The 3D coordinates were
exported via export txt order (Fig. 7).
The post-operative screw tunnels were set to U3.5 mm.
The post-operative models were examined by other
orthopedic surgeons to see if the screws punctured the bone
cortex and measured the distance (Fig. 8a, b).
Statistical analysis
Take the absolute value of the coordinate data difference
before and after the operation starting from 1.1 mm and
filter in 0.1-mm intervals to obtain the number of qualified
or failed insertions. The data were tested using a four-fold
table Chi-square test via SPSS 13.0. Statistical significance
was defined as p \ 0.05.
Distribution of differences in pre- and post-operative
models (Fig. 9).
Result
The results of the inclination angles of C3–C7 on the left
side were 35.50° ± 3.08°, 35.94° ± 2.60°, 36.06° ±
2.72°, 34.64° ± 2.82°, and 29.84° ± 2.23°; they were
35.50° ± 3.08°, 35.94° ± 2.60°, 36.06° ± 2.72°, 34.64°
± 2.82°, 29.84° ± 2.23° on the right side, respectively. A
total of 164 cervical pedicle screws were placed, six of
which punctured the pedicle cortex, and all of the distances
were\2 mm. Among them, three punctured the lateral side
of the pedicle, two punctured the inner side, and one
punctured the inferior side. The absolute values of the
coordinates difference in the entry points between the two
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Fig. 6 Three-dimensional registration. a Post-operative model; b, c three-dimensional registration; d final result

Fig. 7 a–c Comparison of pre- and post-operative screw tunnels; d–f comparison of pre- and post-operative entry points

models were 0.68 ± 0.18, 0.64 ± 0.20, and 0.62 ± precision level at the entry point of 1.2 mm, v2 = 1.346
0.13 mm, respectively, while the exit points were and p = 0.248; When using 2.2 mm as a precision level,
0.88 ± 0.56, 0.32 ± 0.31, and 0.47 ± 0.36 mm, respec- v2 = 3.250 and p = 0.061. At this point, surgery can be
tively. The statistical results show that when using a considered, since this is an accurate representation of the

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Fig. 8 a, b Computed tomography image to check whether the pedicle screws were out of the bone cortex; c, d post-operative anterior–posterior
and lateral X-ray examinations of the cervical spine

screw fixation is the most reliable spinal fixation technique

[19, 20]. However, surgery around the cervical spine is
complicated and dangerous due to the relatively small
vertebral pedicle and the key anatomical structures around
the cervical spine.
A comprehensive evaluation and precise navigation are
extremely important for the surgery. How to design the
screw tunnel precisely and place the screw has been the
tough point in spine surgery. The traditional freehand
method relies on surgeons’ experience to place the pedicle
screw; thus, it has a low accuracy rate. The normal navi-
gation method faces a problem of intraoperative drift; thus,
the screw could easily break through the bone cortex when
the pedicle is small [4, 5, 11, 12, 21–23]. The navigation
Fig. 9 Precision chart template used now was built by several reverse engineering
software packages; thus, it requires manual adjustment.
These factors affect method accuracy and different studies
Table 1 Chi-square test results
show a different navigation accuracy rate (84–97.6%)
X-axis Y-axis Z-axis v2 p [17, 18, 24, 25].
Q D Q D Q D Our study purposed a method to design the screw tunnel
and navigate the pedicle screw. In our series, a total of 164
Enter point (mm)
pedicle screws were placed; of them, six broke through the
1.1 159 7 161 3 162 2 5.255 0.015 \ 0.05 bone cortex. The accuracy rate was 96.3%, relatively high
1.2 161 3 162 2 163 1 1.346 0.248 [ 0.05 compared with other studies [3, 5, 10, 26]. Our study
1.3 161 3 163 1 163 1 1.346 0.248 [ 0.05 depends on Mimics to create the 3D models pre- and post-
Exit point (mm) operatively. We also use it to design the screw tunnel,
2.1 158 6 164 0 164 0 4.244 0.030 \ 0.05 measure the angles, and decide the screw’s entry point and
2.2 159 5 164 0 164 0 3.250 0.061 [ 0.05 direction. Abumi et al. [27, 28] reported a review study that
2.3 162 2 164 0 164 0 0.503 0.498 [ 0.05 focused on posterior pedicle screw fixation for cervical
Q qualified, D disqualified spine. In their article, the overall complication rate was
higher than that in our study. However, the entry point and
design. The Chi-square test results are as shown in screw tunnel were similar to our method, although ours is
Table 1. more precise for placing the pedicle screws. Tofuku et al.
[29] and Lee et al. [6] also reported similar cervical pedicle
screw placement methods based on the characteristics of
Discussion the cervical spine structure. These methods share similar
entry points and screw tunnel designs as those in our study,
The vertebral pedicle is the strongest part of the vertebral but the accuracy was lower than that reported here, per-
body. The pedicle screw went through three columns; thus, haps, due to shifting of the bone or instruments during the
it has a strong holding ability. To date, posterior pedicle operation.

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One innovator in our study is how we rebuilt the model
and designed the screw tunnel using Mimics. The precise
design of the navigation template improved our accuracy.
Hu et al. reported using a printed template to navigate
C1–2 transarticular pedicle screw placement. A total of 64
C1–2 transarticular pedicle screws were placed in that
study, and they found the method effective. Our study
provided a more precise and individual way to design the
screw tunnel that requires cutting and analyzing the 3D
model in different sections. The final results show that this
method was very effective for navigating cervical pedicle
screws (96.3% accuracy).
In our study, when we defined successful pedicle screw
placement as a distance error from the designed entry point
of no more than 1.2 mm and at the exit point of no more
than 2.2 mm, the Chi-square test results showed that
v2 = 3.250, p [ 0.05; that means that at this degree, our
method could place the pedicle screw successfully. Our
study contains three key points: (1) design the screw tunnel
according to the anatomical characteristics of the real-time
rebuilt 3D cervical spine model; (2) design the navigation
template according to the exposure margin from the real-
time spinal model; and (3) design a perfect ‘‘lock’’ point for
the template to avoid intraoperative shifting.
Conclusion
Cervical pedicle screw placement using a rapid prototyping
drill template based on the 3D model is technically feasible
and could enable accurate pedicle screw placement without
the need for extra radiation. This patient-specific technique
is safe and should be further studied in clinical
applications.
Limitations and restrictions
First of all, the greatest shortcoming of our study is that it
does not follow the minimally invasive rule. Second, col-
umn fracture of the cervical spine is not a suitable candi-
date for the template design. Finally, we have performed a
small number of clinical cases. Screw insertion accuracy
was improved compared with the X-ray guidance, as the
actual screw channels are consistent with the ideal screw
channels. Multi-center clinical trials of a larger sample of
our study are currently underway in three provinces in
China. As such, we expect to summarize the advantages
and disadvantages of 3D printing technology in the follow-
up work and promote the relevant clinical applications.
Acknowledgements This study was supported by Grants from the
Fujian Province Health and Family Planning Commission (2012-CX-
34, 2015-2-32), the Educational Department of Fujian Province
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(JA14274), and the Natural Science Foundation of Fujian Province of
China (Grant No. 2016J01607).
Compliance with ethical standards
Conflict of interest The authors declare no competing financial
interest
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