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THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY

Int J Med Robotics Comput Assist Surg 2009; 5: 184–191. ORIGINAL ARTICLE
Published online 11 March 2009 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/rcs.249

A novel computer-assisted drill guide template for


lumbar pedicle screw placement: a cadaveric and
clinical study

Sheng Lu1 Abstract


Yong Q. Xu1
Background The great accuracy of computer-assisted operative systems for
Yuan Z. Zhang2 * pedicle screw insertion makes them highly desirable for spinal surgeries.
Yan B. Li3 However, computer-assisted pedicle screw placement is expensive, and the
LE Xie4 learning curve for these techniques is significant. We have developed a novel
Ji H. Shi1 method of spinal pedicle stereotaxy by reverse engineering (RE) and rapid
Hai Guo1 prototyping (RP) and have validated the method’s accuracy by cadaveric and
clinical study.
Guo P. Chen1
Methods A volumetric CT scan was performed on each desired lumbar
Yu B Chen1
vertebra and a three-dimensional (3D) reconstruction model was generated
1
Department of Orthopedics, with MIMICS 10.1, while the optimal screw size and orientation were
Kunming General Hospital, PLA, determined using UG Imageware 12.1. A drill template was created using UG
Kunming, People’s Republic of China Imageware 12.1, with a surface that is the inverse of the vertebral surface.
2
Department of Orthopedics, the First The drill template and its corresponding vertebra were manufactured using
Hospital Affiliated to the Inner RP. The method was tested on six cadavers without any fluoroscopic control
Mongolia Medical College, Hohhot, at surgery. Eventually, the technology was applied in six clinical cases.
Inner Mongolia Autonomous Region, Results The accuracy of the drill template was confirmed by preoperatively
People’s Republic of China drilling the screw trajectory into the vertebra biomodel. In the cadaveric
3
Department of Anatomy, NanHua experiment, 36 pedicle screws were inserted and no pedicle perforation was
University, HenYang, People’s observed by postoperative CT scan. In the six clinical patients, the best fit for
Republic of China positioning the template was easily found manually during the operation. The
4
Department of Plasticity Forming required time between fixation of the template to the lamina and insertion of
Engineering, Shanghai Jiaotong the pedicle screw into each segment (one or two vertebrae) was 1–2 min. In
University, Shanghai, People’s total, 22 screws were inserted into T12-L5, with two to four screws/patient.
Republic of China No misplacement occurred using the individual templates. Fluoroscopy was
used only once after all the pedicle screws had been inserted. The method
*Correspondence to: Yuan Z. Zhang,
significantly reduces operation time and radiation exposure for the members
Department of Orthopedics, the First
Hospital Affiliated to the Inner
of the surgical team.
Mongolia Medical College, Hohhot, Conclusions The authors have developed a novel computer-assisted drill
Inner Mongolia Autonomous template for lumbar pedicle screw placement. This method has shown its
Region, People’s Republic of China. ability to customize the placement and size of each screw, based on the unique
E-mail: drlusheng@yahoo.com.cn morphology of the lumbar vertebra. The potential use of drill templates to
place lumbar pedicle screws is promising. Copyright  2009 John Wiley &
Sons, Ltd.
Keywords computer-assisted; rapid prototyping; drill template; pedicle screw;
reverse engineering; image-guided surgery

Introduction
Accepted: 22 January 2009 In lumbar pedicle screw insertion, it is important both to select the correct size
of screw and to place it properly within the pedicle to ensure good anchoring.

Copyright  2009 John Wiley & Sons, Ltd.


Novel computer-assisted drill guide template for lumbar pedicle screw placement 185

Manual placement has a high associated rate of unplanned A


perforation, which is the major specific complication
of pedicle screw placement and causes a high risk
of bone weakening or lesions of the spinal cord,
nerve roots, or blood vessels ( (1,2)). The principle of
image guidance is to register the patient’s pre-operative
computed tomography (CT) scans, thus permitting the
surgeon to navigate simultaneously within the patient
and the CT scan volume. Such navigation systems have
shown good clinical results ( (3–5)). There are, however,
several disadvantages associated with navigation systems.
In cases where screws are to be placed in more than one
vertebra, it is necessary to perform a separate registration
step for each vertebra. Intraoperative registration of bone
structures takes up to several minutes, and thus the time
taken for the overall procedure is increased compared
with a conventional approach. The navigation equipment
often requires additional personnel to be present during
surgery, and this, together with the increased operating
time, leads to a higher risk of intraoperative infection
( (6)). The navigation equipment is cumbersome and
occupies a lot of space in the operating room. Finally,
only a few hospitals can bear the costs of sensor or
robot-based systems ( (7,8)). One way to overcome these
B
drawbacks is the production of personalized templates.
These are designed using pre-operative CT to fit in a
unique position on the individual’s bone, and they have
carefully designed holes to guide the drill through a pre-
planned trajectory. Such guides have been introduced in
several reports, but their methods were applied only in
human cadavers ( (9–12)); until now, no clinical report
has been made. The objective of this study was to evaluate
the accuracy of a novel drill-guide template for lumbar
pedicle screw placement on six lumbar cadavers, and this
was successfully extended to clinical trials on six patients.

Material and Methods


Design of the computer-assisted drill
template Figure 1. 3D model of the lumbar vertebrae: (A) CT scan; (B) 3D
construction of lumbar vertebrae
A spiral three-dimensional (3D) CT scan (GE, LightSpeed
64-Row, VCT, USA) was performed on a cadaver lumbar
spine with 0.625 mm slice thickness and 0.35 mm in- the least channel of the pedicle (Figure 2B), because
plane resolution. The images were stored in DICOM the pedicle is irregular. Last, a circle was found whose
format and transferred to a workstation running MIMICS diameter was the least diameter of this ellipse and
10.1 software (Materialise, Belgium) to generate a 3D connected this projected circle between the vertebra
reconstruction model for the targeted lumbar vertebra and the lamina to obtain the optimal pedicle screw
(Figure 1). trajectory (Figure 2C). Then, a 3D verterbal model was
The 3D vertebral model was exported in STL format, reconstructued with a virtual screw placed on both sides
and then opened in a workstation running UG imageware (Figure 2D). The optimal screw size was also determined
12.0 (EDS Co., USA) for the optimal screw size and according to the size of pedicle shaft. A surgical plan was
orientation. First, the 3D lumbar model was opened and established a day before surgery and the diameter and
the image of the pedicle was extracted from the 3D model. insertion point of screws can be confirmed.
Second, the pedicle was projected to the vertebrae and Once this had been done, a drill template was
lamina along different directions (Figure 2A). The interior constructed with a surface designed to be the inverse
boundary circumference of the pedicle’s projection is of the vertebral surface. This was meant to enable a

Copyright  2009 John Wiley & Sons, Ltd. Int J Med Robotics Comput Assist Surg 2009; 5: 184–191.
DOI: 10.1002/rcs
186 S. Lu et al.

A B

D
C

Figure 2. Analysis of pedicle screw channel: (A) pedicle and its positive projection; (B) circle of pedicle projection; (C) pedicle
screw channel of pedicle projection; (D) pedicle screw placed virtually into the 3D vertebral model

lock-and-key structure similar to a physical casting of the screws were placed at each level by one surgeon (Dr Yu
vertebral surface, and it specifically avoided overlap onto B. Chen).
adjacent segments (Figure 3).
The computer model was then exported in STL
format and the vertebra biomodel and drill template Clinical application
were both manufactured in acrylate resin, using the
stereolithography rapid prototyping technique. During September 2007–June 2008, six patients (five
males, one female, aged 28–68 years) with lumbar
spinal pathology requiring instrumentation underwent
Cadaveric experiment posterior instrumentation of the lumbar spine. In each
case, a personalized drill template was sterilized and
used intraoperatively to navigate the insertion of pedicle
Six randomly chosen conserved human lumbar cadavers
screws. Intraoperative fluoroscopy was used only once
were obtained. Their lumbar spines (L1–L3) were
after the pedicle screws were inserted, and the operative
examined with conventional radiographs in two planes
time for every screw was recorded. Postoperative
(anteroposterior and lateral) to exclude anomalies,
radiography and CT scanning were used to assess the
tumours and severe multisegmental changes other than
accuracy of the pedicle screw placement.
osteoporosis and moderate spondylosis. Preoperative CT
scans (L1–L3) were acquired using a standard algorithm
with a slice thickness of 0.625 mm, and the computer-
assisted navigational templates were made according to Results
the individual lumbar vertebrae. The length and diameter
of the pedicle axis in the horizontal plane were measured Using the virtual 3D model, the optimal entry point for
for every pedicle. No intraoperative fluoroscopy or the bore can be chosen, thus determining the entry point
radiographic control was used during operation. Titanium and direction for the pedicle screw. The drill template

Copyright  2009 John Wiley & Sons, Ltd. Int J Med Robotics Comput Assist Surg 2009; 5: 184–191.
DOI: 10.1002/rcs
Novel computer-assisted drill guide template for lumbar pedicle screw placement 187

A clinical profile and details of surgical procedures, see


Table 1.
The individual navigational template technique has
the ability both to customize the placement and size of
each screw, based on the unique morphology of each
patient’s lumbar vertebra, and to preoperatively prepare
the surgical plan (Figure 5). No additional computer
assistance was needed during surgery, and fluoroscopy
was used only once, after all the pedicle screws had been
inserted. The method thus significantly reduced radiation
exposure for the members of the surgical team. It took
about 16 h to manufacture the RP model, and the price of
each RP model of the vertebrae and navigational template
was about $20.
Postoperative CT scans for controlling the pedicle bore
showed that the individual template has a higher precision
B
than other techniques. No misplacement occurred using
the individual template. To achieve this, exact preparation
of the bone surface was essential, including thorough
removal of the attached muscle and fat tissue without
damage to the bony surface structure.

Discussion
Various methods have been explored for pedicle screw
placement in the lumbar vertebrae. Traditional methods
of intraoperative spinal localization still have an important
role to play in the field of spine surgery; however, it is clear
that these methods have shortcomings ( (3)), which have
led to the use of computer-assisted placement ( (13,14)).
Figure 3. (A) 3D model of navigational template; (B) naviga- Image-guided techniques provide detailed views of hidden
tional template fitted to the vertebrae well spinal anatomy that can be used for surgical planning
and navigation. Several caveats should be considered;
however: (a) the learning curve for these techniques is
was created to fit the postural surface of the vertebra very significant; (b) errors may occur if adjacent segments of
well in the cadaveric experiment. Thirty-six pedicle screws the spine or the registration frame and optical array shift
were inserted, and no pedicle perforation was observed intraoperatively; (c) the tracking of optical array devices
by postoperative CT scan (Figure 4). can be obscured by surgeons or tools; (d) the technology
Six patients were also treated using this drill guide is expensive; (e) the techniques can lengthen the time of
system, and the concept of a template fitted to the surgical procedures.
combined posterior lumbar worked very well during Using individual vertebral templates eliminates the
each operation. Each navigational template fitted its need for complex equipment and time-consuming
corresponding vertebral biomodel perfectly, and each procedures in the operating room. These templates are
screw was found to be inserted through the drill hole a simple and low-cost solution that provides exact,
into the pedicle of the desired vertebra. No violation safe and fast implementation of elective surgery on
of the pedicle was found by visual inspection. During bone structures. Template production involves reverse
the operation, the best fit for positioning the template engineering (RE), the process of duplicating an existing
was easily found by hand, because no significant free component, subassembly or product without the aid
motion of the template occurred when it was pressed of drawings, documentation or a computer model. A
slightly against the vertebral body. Thus, the navigational preoperative CT scan is mandatory both to generate the
template could be used as an in situ drill guide. Operation individual templates and to establish a precise spatial
time was reduced through use of the navigational correspondence between the individual bone structure
template; the required time between fixation of the in situ and the intended position of the tool guide. The
template to the lamina and insertion of the pedicle goal of this study was to evaluate the practicability and
screw into each segment (one or two vertebrae) was accuracy of image-based individual templates.
1–2 min. In total, 22 screws were inserted into T12 The technique also has potential sources of error.
through L5, with two to four screws/patient. For a Because the 3D model of each vertebra is constructed

Copyright  2009 John Wiley & Sons, Ltd. Int J Med Robotics Comput Assist Surg 2009; 5: 184–191.
DOI: 10.1002/rcs
188 S. Lu et al.

B
A

Figure 4. Experiment of the navigational template: (A) trajectory of pedicle screw according to the digital template; (B) placement
of pedicle screw; (C) accurate pedicle screw placement was confirmed with X-ray; (D) accurate pedicle screw placement was
confirmed with CT scan

manually or automatically, there is a potential for error geometric accuracy alone does not ensure accurate screw
in the procedure. Furthermore, the RP model could placement. In the clinical setting, a template should be
deviate from the computer 3D model, but existing RP able to be used as an in situ drill guide, and any movement
technology can control deviation to 0.1 mm. Finally, between the bones will affect the accuracy.

Copyright  2009 John Wiley & Sons, Ltd. Int J Med Robotics Comput Assist Surg 2009; 5: 184–191.
DOI: 10.1002/rcs
Novel computer-assisted drill guide template for lumbar pedicle screw placement 189

Table 1. Clinical profile and details of surgical procedures there could be trouble with soft tissue on the bone. Thus,
it is very important that the surgeon take great care
Extent No. of
Age Lumbar of Screw lumbar in stripping the soft tissue off the surface of the bone.
Case (years) Gender disorder fusion location screws Bone preparation must be done more cleanly than in
conventional surgeries, and the soft-tissue preparation
1 37 M TLF L1–L3 L1, L3 4
2 34 M TLF L1–L3 L1, L3 4 will take more time. Because more contact with the
3 62 M DLS L4–L5 L4, L5 4 bone surface enhances the stability of the template,
4 43 F TLF L2–L4 L2, L4 4 we regularly remove the posterior ligament so the
5 68 M DLS L5–S1 L5 2
6 28 M TLF T12–L2 T12, L2 4 template can make contact with the spinous process.
This method need not expose the transverse process,
DLS, degenerative lumbar spondylosis; TLF, thoracolumbar fracture. which reduces the harm to soft tissue in that area.
Still, compared with the conventional approach, the
Because any minor variation in the shape of the template method may require more soft-tissue damage. If
vertebra would introduce inaccuracy through poor fit, attention is paid to these limitations, accurate matching

B
A

Figure 5. Design and manufacture of navigational template: (A) 3D model of navigational template; (B) solid model of navigational
template and vertebra; (C, D) navigational template in operation; (E–G) CT scan, showing the accurate trajectory of pedicle screw
after operation

Copyright  2009 John Wiley & Sons, Ltd. Int J Med Robotics Comput Assist Surg 2009; 5: 184–191.
DOI: 10.1002/rcs
190 S. Lu et al.

E F

Figure 5. (Continued)

of the template can be achieved, allowing accurate drill template is about $20, so individual templates can
trajectories. be produced at a reasonable price compared with the
The template created by the above technique can cost of intraoperative navigation systems. If a service
be used in trauma, tumour and degenerative surgery provider produces the template using the measuring data
and in revision surgery for every level of the lumbar obtained during operative planning, production takes
spine. The cost for one screw insertion using the approximately 16 h.

Copyright  2009 John Wiley & Sons, Ltd. Int J Med Robotics Comput Assist Surg 2009; 5: 184–191.
DOI: 10.1002/rcs
Novel computer-assisted drill guide template for lumbar pedicle screw placement 191

In the past decade, some authors have designed dif- by the China Postdoctoral Science Foundation (Grant No.
ferent individual templates for pedicle screw placement. 20080431420) and Yunnan Natural Science Foundation (Grant
Berry et al. ( (11)) used a three V-shaped knife design No. 2008CD210).
to support the drill template. An advantage of using this
design is that excessive soft-tissue dissection from the ver-
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assistance with the CT data collection. This work is supported

Copyright  2009 John Wiley & Sons, Ltd. Int J Med Robotics Comput Assist Surg 2009; 5: 184–191.
DOI: 10.1002/rcs