DIMENSIONAL EVALUATION OF TAILOR-MADE CRANIOPLASTY IMPLANTS
Dalberto Dias da Costa1, Sérgio Fernando Lajarin2.
Universidade Federal do Paraná, DEMEC, Av. Cel. Francisco H. dos Santos, 210 CEP 81531-990, Curitiba, Brasil,
1 dalberto@ufpr.br
2 fer.espanhol@gmail.com
Abstract: Cranioplasty is a medical technique used to
recover large cranial defects and has presented a great
development in last decades. This high evolution is credited
to the discovery of new biomaterials and the efficiency of
information systems, such as CT (Computed Tomography);
MIP (Medical Image Processing); CAD (Computer-Aided
Design); CAM (Computer-Aided Manufacturing) and CNC
(Computer Numerical Control). However, the quality of the
prefabricated implants, concerning to dimensional and form
errors, still remains poorly investigated. The aim of this
paper is presented and discussed the method and results of a
dimensional evaluation of a cranioplasty implant
manufactured from a set of computer tomography (CT)
images. The presented article contains a short review
concerning about the manufacturing process used to produce
customized implants for medical application, highlighting
the importance of the metrological resources available for
the assessment of dimensional quality of this kind of
product. The methodology contains the steps and resources
employed in the dimensional evaluation of an acrylic
implant cast from a dried human skull. The influence of the
quality of CAD models was evaluated with a Coordinated
Measuring Machine (CMM) by measuring a standard sphere
used to probe tip calibration. Despite of the relative low
deviation found in the manufactured implant, as compared
to the current reports in the specialized literature, it was
observed that the quality of digital models and the
localization procedures impact directly on the measured
values.
Keywords: three-dimensional modeling, coordinate
measuring machine, localization, cranioplasty.
1. INTRODUCTION
The restoration of large cranial defects caused by
traumas or congenital represents a difficult task in medicine.
This difficult is partially due the unavailability of a bonelike
material and the poor cosmetic results in case of autograft
implantation [1].
The application of alloplastic materials has growing in
the last years, in particularly because the implants can be
previously produced and according to some researchers
[1,2,3,4] contribute to the reduction of surgical time and
infections risks.
Despite of alloplastic materials couldn’t replace bone
tissues in all of its functions; some of them, in special
titanium, hydroxyapatite and polymethylmetacrilate
(PMMA) provide the necessary brain protection.
The enhancements of medical imaging technologies
observed in the last decades, such as tomography, magnetic
resonance and ultrasound, have provide the basements for a
new discipline named Medical Imaging Processing (MIP)
which make intensive use of information systems to process
an convert to a vetorized representation the images acquired
from human organs.
Computer Tomography (CT), for example, is a MIP
variant that allows the modeling of hard tissues by creating a
geometrical representation of complex bones like those
found in craniofacial skeleton.
The combination of Computer-Aided Design (CAD),
Computer-Aided Manufacturing (CAM) systems, whose
knowledge is highly disseminated in the mechanical field,
and CT imaging have provide the basic resources to model
and manufacture tailor-made implants.
However, the quality of the prefabricated implants,
concerning to dimensional and form errors remains poorly
investigated. The aim of this paper is presented and
discussed the method and results of the dimensional
assessment of a cranioplasty implant cast from a set of
computer tomography (CT) images.
A short review of the up-to-date processes applied to
manufacture cranioplasty implants is presented next with
special emphasis on the importance of the metrological
resources demanded to inspect this kind of complex product.
1.1. Rapid Prototyping
Rapid Prototyping (RP) is a generic name given to a
set of processes based on the deposition, layer-by-layer, of a
thin slice material until a solid form is achieved [5].
According to Leong et al. [5] and Dietmar et al. [6], this
kind of processing has become a valuable alternative to
produce customized craniofacial models.
In general, the digital model of injured region is a solid
model represented by a finite set of non-regular triangles.
Therefore, the RP software needs to slice it in a limited
number of contours before start the deposition phase, which
can be accomplished, among other, by laser sintering (SLS),
fusion and deposition (FDM) or three-dimensional printing
[5].
On the presence of surfaces with great curvatures, the
number of slice needs to be enlarged in order to reduce the
dimensional and form errors which are influenced by the
stair-case effect [7]. In addition, some material presents a
high shrinkage after solidification, what implies in another
source of error.
Choi et al.[8] report about dimensional error on RP
models of a craniomaxillary complex and a mandible. They
attribute to the average error the low spatial resolution
achieved in CT phase and the difficulty in determine a
correct threshold value during image processing.
Unfortunately, the measurement method was based on a
simple vernier caliper positioned above craniometrical
landmarks, which contribute for a poor repeatability of
measured values.
1.2. Forming
When implants are mass produced, forming is
considered a very attractive process, due the low cost and
high precision achieved in the final product. By the other
hand, the high investment required to project and build a
specific die implies in a costly final product in the case of
tailor-made implants.
In addition, the selected biomaterial needs to present a
considerable plasticity in order to deform in correspondence
to the mechanical tension imposed by punch and the die
block. In almost the cases, forming is applied to produce
auxiliary materials for general applications, such as
dynamical meshes or fixturing devices.
The application for forming to produce customized
implants is scarcely reported in literature. Carr et al. [9]
used a machined epoxy die to draw a titanium plate. Joffe et
al. [10] made master templates from machined polyurethane
foam in order to copy the defect borders and press them in
titanium plates.
1.3. Casting
Traditionally, casting is considered a process where a
liquid material is solidified inside a preexisting mold. As the
material remains liquid during a relatively long time
interval, very intricate forms can be produced with low cost.
Some kind of biopolymers like PMMA, for example, can be
intraoperative, not requiring the construction of dedicated
molds and has been claimed as an advantageous
cranioplasty technique [11].
In the case of titanium, a more controllable processes
needs to be employed, because it is a very reactive metal, in
special on higher temperature. In general, a vacuum casting
should be applied to avoid the reaction with the surrounding
gases, like oxygen and nitrogen. This drawback results in
more expensive implants.
1.4. Machining
Machining processes are applied to produce very
precise products from the progressive removing of an
unwanted portion of a blank material. Despite of their lager
dissemination in metalworking industries, they present some
limitation to fabricate smaller and complex geometries,
which are easily manufactured by casting or rapid
prototyping techniques. Theses limitations arise from the
interaction occurring between the cutting tool and the solid
blank. In addition, in order to produce lighter implants the
volume of removed material (chips) needs to be very high,
what implies in a significant loss.
Some researchers have reported on the application of
machine processes, in special the milling, to produce master
templates [1] or molds [3] for further processing. However,
the use of direct milling is unusual. Heissler et al. [12] have
mentioned the drawbacks of direct milling of titanium
blocks, including the material waste and the long lead time.
Bazan [4] produce a milled implant from PMMA
(acrylic) block. By choosing a simpler model and a cheaper
material, that author demonstrates some advantages of the
direct machining. Among them, it was highlighted a low
dimensional deviation between the digital model and the
produced implant.
1.5. Assessment of Dimensional and Form Deviations
The evaluation of dimensional errors in customized
implants is not a simple task. Some researchers [4,8,13]
have presented the dimensional differences among the
original model, or the digital one, and the manufactured part
basing on simpler techniques, such as the distances
measured with calipers.
In almost the cases, implants are constituted of
complex surfaces, what implies in a higher degree of
difficulty for manual measurements. Despite of their
relevance for a rough evaluation, there is a lack of
confidence concerning the real differences among the
models and the implants. In addition, there is an absence of
an ideal model, or nominal values, for reference purpose,
since the source model is a digital representation constructed
from CT images.
Nowadays, there is a branch of dimensional metrology
specialized in the evaluation of complex surfaces, also
referred as “free-form inspection”. In that case, the
instrumentation is more sophisticated than the manual
calipers. There are two distinct techniques: the contact and
non-contact inspection. Contact measuring, which can be
performed in Coordinated Measuring Machines (MMC) are
based on a probe triggering device. By the other hand, the
non-contact method allows a faster scanning of the
interested region by means of a laser technology [14,15].
Independently of the employed resources, there is a
fundamental problem to solve before staring the measuring,
which is concerned to how to localize a free-form part
related to a fixed measurement frame.
Initially, the digital model is defined in a properly
coordinate frame called Design Coordinated System (DCS).
By the other hand, the part to be measured is positioned in
the Measurement Coordinate System (MCS). Therefore, the
great deal is to establish a relationship between these two
systems, which is currently called localization problem [14].
The Figure 1 provides a graphical illustration of this
problem.
Figure 1 – Schematic representation of the localization problem .
Traditionally, localization is achieved by presenting the
part at a desired position and orientation, using special tools,
fixtures or other part presentation/orientation devices totally
dedicated for specific products. In practical applications,
localization can be regarded as a two-step process: (i) find
the point-to-point corresponding relationship between
measurement and design surfaces; and, (ii) solve the 3D
rigid transformation between these two surfaces to bring
them into a common coordinate system [14].
An interesting technique to correct the location is
presented by Spitz [16] and Lai and Chen [17]. This is
known as principle 3-2-1, a group of data is inspected with
the intention of establishing a reference grating in relation to
the component. Three points are measured from the first
datum to establish a plane. Two points are measured from
the second datum to establish a second plane perpendicular
to the first. Finally, one point is measured from the last
datum perpendicular to the first two, establishing in that way
the origin and three-dimensional direction of the system of
coordinates. However, as Li and Gu [14] pointed out this
approach has shortcomings because the parts are required to
have plane surfaces, and the result is very sensitive to
measurement and dimensional errors. Besides, because of
the manufacturing errors on the datums, the localization
quality is sensitive to the selection of those points.
Many approaches and methods have been developed
for localization with higher accuracy, efficiency and
robustness. An example is presented by Lai and Chen [17]
that developed a method of refined positioning through
iterative measurements. That and other similar methods [14]
are applied after a rough localization by the 3-2-1 principle.
In the case of cranioplasty implants, besides the
difficulty related to implant localization, there is another
source of error due the previously methods applied to
produce the digital model. As pointed out by some authors
[1,4,8,13] computer tomography implies in a volume-
averaging error, which arise from the slice thickness adopted
in X-ray scanning. This kind of error is more significant in
surfaces with higher curvature. In this situation, the last slice
will create a flat area at the ending of the scanning
processes. The presence of a undesired flat area can influence
the localization procedures and difficult the establishment of
the relationship between the DCS and MCS.
2. MATERIALS AND METHODS
The procedures proposed here started with the work
developed by Bazan [4], and also reported by Da Costa et al.
[18], about the direct machining and evaluation of one
PMMA implant. The primary information source of those
works was a dried human skull which was modeled from CT
scanning. The reconstructed three-dimensional CAD model
was generated in STL(Stereolithography) format. Obviously
that kind of representation is an approximation and its
quality depends strongly on the number of triangles.
In modelled area of interest (top calvaria, illustrated in
Figure 2, on top), 145696 triangles were used. That digital
model was used later to produce a physical part by direct
machining of a PMMA block.
With the purpose of manufacturing the same physical
model, however, by applying another manufacturing
process, a dental gypsum mold was machined for further
PMMA polymerization.
In a second stage the influence of the model quality on
the localization error using a standard sphere was
investigated. In the third stage, the implant produced in the
gypsum mold was evaluated by the procedures applied in
the sphere measurement. These three stages are described
next.
2.1. Tailor-made implant of PMMA
A casting mold was machined from the digital model
of a dried human skull reconstructed by Bazan[4]. The mold
was composed of two halves. One is the punch (calvaria´s
inner surface) and other is the die (calvaria´s outer surface),
as showed in Figure 2.
Figure 2 – STL Digital model obtained by Bazan [4] (top), and the
die/punch of the mold (down).
 The external structures of the mold were made from
epoxy, which was further filled with dental gypsum. A
CAM system (EdgeCAM® from Pathtrace) was applied to
generate the tool path to mill the gypsum core. All machine
phase was undertaken in vertical axis machine center
(Discovery 4022 – Romi S.A). The milled surfaces were
impregnated with silicon demolder (UltraLub®).
An auto-polymerized acrylic resin composed of two
parts of liquid (monomer) and three parts of powder
(polymerized beads) was mixed at room temperature and
poured into the mold cavity. Before the polymerization
starting the mold was closed and punch pressed with a
hydraulic press. After thirty minutes of polymerization the
mold was opened and the implant was extracted.
2.2. Evaluation
In order to verify the influence of the digital model
quality on the localization results, three different models of
a hemisphere were built, as presented in the Figure 3. The
spherical form was chosen due its simplicity and existence
of an ideal (analytical) model for further comparisons.
The real hemisphere, Figure 3a, was the stainless steel
ball with 19,05mm in diameter used for CMM probe
calibration. The first CAD model (Figure 3b) was created in
IGES (Initial Graphics Exchange Specification). The second
(Figure 3c) was built from 10 images of the circumferences
resulting from the intersection of sphere with parallel planes
equally spaced. The images were created inside a squared
field of view with a pixel/millimeter ratio below 0.04 mm.
After the exportation of images bitmaps, their borders were
segmented and the correspondent surface reconstructed in a
STL representation using specialized software (Mimics®).
Flat area
(a) (b) (c)
Figure 3 – (a) calibration standard sphere; (b) model 1; (c) model 2; (d)
model 3 with deformation details.
The digital model generated by Bazan [4] presented a
flat area at the top of the outer surface, resulting from the
intersection of the last CT slice with the scanned surface. A
schematic representation of this failure is shown in Figure 4,
which is related to the “staircase effect” whose magnitude is
dependent on the slice thickness and surface curvature. The
hemisphere model (figure 3d) was built in order to evaluate
the effect of this deformation on the localization quality. It
was obtained by lofting 10 circumferences, similar to those
used in figure 3c, with another specialized CAD system
(Solidworks®). This lofting process results in a spherical
surface plus a planar one corresponding to the intersection
of the 10th plane.
Figure 4 - Staircase effect from CT scan
All of the measurements were carried in a MMC
(Sheffield, Discovery D8) with spherical contact probe of
2mm and uncertainty of 5 + L/200 (mm). This kind of
machine is numerically controlled and its software
(PCDIMS CAD++) offers resources for rough localization
through the “3-2-1 principle” and refined, which is called as
“Best-Fit”.
Following the hemisphere evaluation, the cast implant
was measured with the same procedure. The implant was set
in CMM table from its bottom planar surface. A rough
alignment was made based on the “3-2-1 principle” followed
by the refinement after scanning the whole surface with 164
points.
3. RESULTS AND DISCUSSION
The machined gypsum mold presented an excellent
surface finish and a detailing level similar to the digital
model. The polymerization and withdrawing were done
without problems. The cast PMMA shows a good match
between the external surface and its corresponding one at
the skull.
The results obtained after compare the steel
hemisphere with three different digital models (see figure 3
for details) allows to affirm that exists a considerable
(d) influence of the quality model on the total deviation (radial
deviation). The model with a flat area at the hemisphere top
produced the greatest deviation values, independently of the
applied localization method, as shown in tables 1 and 2.
As the presence of flat areas is a consequence of a
normal CT reconstruction which contributes to lower the
model quality, was decided to eliminate it in order to reduce
the localization error. Accordingly, in the implant
measuring, the touched points were acquired outside the flat
area.
The Figure 5 shows the distribution of the measured
points on the implant surface. It was observed that the points
were distributed between 0,298 (MX) and -0,243 (MI),
resulting in a total deviation (DV) equal to 0,541 mm.
It was also observed a concentration of positive values
at the implant extremities and a more concentration of
negative differences at the implant central area. This type of
pattern could be influenced by the localization error other
than by manufacturing ones.
 The traditional 3-2-1 principle, what is widely applied Table 1– Sphere center and radial deviation in models measured, after
principle 3-2-1.
in the localization of prismatic parts, reveals to be inefficient
Radial deviation
to localize the inspected surface when the results of tables 1 Model X error Y error Z error
(mean values)
and 2 are compared and should be consider as a rough 1 0,042 0,011 -0,403 -0,778
localization. In order to minimize the localization error it’s 2 0,087 -0,077 -0,084 0,663
necessary to enlarge the number of measured points and 3 0,144 -0,136 -0,034 1,024
carry out successive refinements. The procedure adopted
here was that provided by PC-DMIS package, which is Table 2– Sphere and radial deviation in the models measured after Best-Fit.
highly dependent of quantity of measured points and also of Radial deviation
Model X error Y error Z error
the number of iterations, i. e., the subsequent localization (mean values)
refines the preceding one. 1 -0,004 0,030 0,002 0,003
2 0,006 -0,014 -0,214 -0,402
3 0,047 -0,041 -0,345 -0,860

Figure 5 - Measurement results: (left) cast PMMA implant, (center) distribution of the measured points on STL model, (right) errors indications.

investigation conducted here it was possible to observe that

4. CONCLUSIONS the quality of digital model influence the localization results.
The flat areas, which are resulting from tomography
The development of specialized information systems
process, should not be scanned for localization purpose,
for the acquisition and processing of medical images has
since they produce a considerable noise in the localization
become possible the creation of geometrical models of
procedures. The better results were achieved without
humans organs. Thanks to these new technologies
considering this kind of plateau and carry on a refined
cranioplasty implants can be prefabricated for repair large
localization with a large number of measured points in an
defects, contributing to a shorter surgical time and a better
iterative process.
cosmetic result.
Despite of a better localization achieved with
Unfortunately, from the geometrical point of view,
successive refinements, the STL model is an approximation
almost types of craniofacial implants are compound of very
of the original dried skull and its planar faces also impacts
complex surfaces. This high degree of complexity limits the
on the global error. Therefore, a separation of the
available measuring methods which can be applied in their
manufacturing error from that induced by localization
inspection. The use of vernier calipers as sometimes
procedures was not possible.
reported in the current literature [4,8,13] should be
considered as a roughly assessment of real difference among
the manufactured implant and original model.
5. ACKNOWLEDGMENTS
The main conclusion of this work points to the choice
of a more reliable technology, such those found in
We thanks the UFPR/FUNPAR and CAPES for their
Coordinated Measuring Machines (CMM) equipped with
financial support.
dedicated inspection software.
However, despite of their ability in conducting
automated inspection of three-dimensional parts, there is a
fundamental problem, called localization, concerning how to
establish a relationship between the DCS and MCS. In the
6. REFERENCES [12] Heissler E., Fischer F. S., Bolouri, S., Lehmann, T.,
Mathar, W., Gebhardt, A., Lanksch, W., Bier, J.,
Custom-made cast titanium implants produced with
[1] Eufinger H., Saylor B., Computer-assisted Prefabrication
CAD/CAM for the reconstruction of cranium defects,
of Individual Craniofacial Implants, AORN Journal, v.
International Journal Oral Maxillofacial Surgery, 27, p.
74, n. 5, nov. 2001.
334-338, 1998.
[2] Hieu L.C., Bohez E., Vander Sloten J., Phien H.N.,
[13] Bouyssié J. F., Bouyssié S., Sharrock P., Duran D.,
Vatcharaporn E., Binh P.H., An P.V.,To N.C. e Oris P.,
Stereolithographic models derived from X-ray
Design and manufacturing of personalized implants and
computed tomography - Reproduction accuracy,
standardized templates for cranioplasty applications,
Surgery Radiologic Anatomy, Vol. 19, p. 193 – 199,
IEEE ICIT’02, Bangkok, THAILAND, p. 1025-1030,
1997.
2002.
[14] Li Y., Gu P., Free-form surface inspection techniques
[3] Schiller C., Rasche C., Wehmöller, Beckmann F.,
state of the art review, Computer-Aided Design, Vol.
Eufinger H., Epple M. e Weihe S., Geometrically
36, pp. 1395–1417, 2004.
structured implants for cranial reconstruction made of
biodegradable polyesters and calcium phosphate/calcium
[15] Lin Y. P, Wang C. T., Dai K. R., Reverse engineering
carbonate, Biomaterials, 25, p. 1239–1247, 2004.
in CAD model reconstruction of customized artificial
joint, Medical Engineering & Physics, Vol. 27, pp.
[4] Bazan O., Machining of the cranioplasty prosthesis from
189–193, 2005.
tomographic images, Master in Engineering Dissertation,
Mechanical Engineering Faculty, Federal University of
[16] Spitz S.N. Dimensional inspection planning for
Paraná, Curitiba, Brazil, 2004 [in Portuguese].
coordinate measuring machines, PhD Dissertation,
University of Southern California; 1999.
[5] Leong K. F., Cheah C. M., Chua C. K., Solid freeform
fabrication of three-dimensional scaffolds for
[17] Lai J. Y., Chen K. J., Localization of parts with
engineering replacement tissues and organs,
irregular shape for CMM inspection, Int J Adv Manuf
Biomaterials, 24, p. 2363–2378, 2003.
Technol, Vol. 32, pp. 1188-1200, 2007.
[6] Dietmar W., Sittinger M., Risbud M. V., Scaffold-based
[18] Da Costa, D. ; Pedrini, H. ; Bazan, Prosthesis
tissue engineering: rationale for computer-aided design
machining from tomographic images. In: Congresso
and solid free-form fabrication systems, Trends in
Brasileiro de Engenharia de Fabricação, 2005,
Biotechnology, v. 22, n. 7, p. 354-362, Jul. 2004.
Joinville. Anais do 3º COBEF, 2005. [in Portuguese].
[7] Kulkarni P., Marsan A., Dutta D., A review of process
planning techniques in layered manufacturing, Rapid
Prototyping Journal, Vol. 6, N. 1, p. 18-35, 2000.

[8] Choi J.-Y., Choi J.-H., Kim N.-K., Kim Y., Lee J.-K.,
Kim M.-K., Lee J.-H., Kim M.-J., Analysis of errors in
medical rapid prototyping models. Int. Jornual Oral
Maxillofacial Surgery 2002; 31: 23–32.

[9] Carr J. C., Fright W. R., Beatson R. K., Surface

Interpolation with Radial Basis Functions for Medical
Imaging, IEEE Transactions on Medical Imaging, v. 16,
n.1, p.96-107, feb. 1997.

[10] Joffe J. M., Aghabcigi B., Davies E. H., Harris M. A

retrospective study of 66 titanium cranioplasties,British
Journal of Oral and Maxillofacial surgery, vol. 31, p.
144-148, 1993.

[11] Sherburn E. W., Silbergeld D. L., A new method of

acrylic cranioplasty, Surgery Neurology, Vol. 46, pp.
292-294, 1996.