Journal of Cranio-Maxillo-Facial Surgery 50 (2022) 686e691

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Journal of Cranio-Maxillo-Facial Surgery

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Clinical application of automated virtual orbital reconstruction for

orbital fracture management with patient-specific implants: A
prospective comparative study
Yurii Chepurnyi*, Olena Zhukovtseva, Andriy Kopchak, Oleksandr Kanura
Department of maxillo-facial surgery and innovative dentistry, Bogomolets National Medical University, T. Shevchenka Blvd, 13, 01601, Kyiv, Ukraine

a r t i c l e i n f o a b s t r a c t

Article history: The aim of the study was to compare automated and manually conducted (slice-by-slice) virtual orbital
Paper received 25 January 2021 wall reconstruction in terms of PSI design, manufacture, and clinical application for orbital fracture
Received in revised form management.
2 March 2022
Patients with orbital wall fractures were evaluated for the potential for treatment with PSI, based on
Accepted 26 May 2022
automated virtual wall reconstruction; these formed the main group. The surgical outcomes of these
Available online 3 June 2022
main-group patients' treatments were compared with those of the control group, which comprised
patients randomly selected for this study, each of whom had the same orbital trauma patterns and were
Keywords:
Fracture reconstruction
also managed with PSI. However, the control group patients were treated using ‘slice-by-slice’ virtual
Orbital fracture orbital reconstruction.
Orbital implant Mean volume differences between the intact and reconstructed orbit were 0.65 ± 0.26 cm3 in the
Patient-specific implant (PSI) main group (n ¼ 23) and 0.57 ± 0.23 cm3 in the control (n ¼ 27; p ¼ 0.837). In both groups, no cases of
implant malposition or enophthalmos were detected after surgery. Orbital shape difference was similar
for the main group and the control, at 3.3 ± 3.5% and 3.25 ± 2.5%, respectively (p ¼ 0.929). Diplopia was
diagnosed at the 3-month follow-up in 13.0% of the main group and in 11.1% of the control (p ¼ 0.651).
The average times spent on computer-aided design (CAD) procedures, including segmentation, virtual
orbital reconstruction, and PSI design, were 36.7 ± 6.9 min in the main group and 72.9 ± 7.7 min in the
control group (p < 0.001).
Within the limitations of the study it seems that PSI based on automated virtual reconstruction is a
relevant alternative treatment option for orbital fractures because of its clinical efficacy that is similar to
PSI based on a ‘slice-by-slice’ CAD protocol.
© 2022 The Authors. Published by Elsevier Ltd on behalf of European Association for Cranio-Maxillo-
Facial Surgery. This is an open access article under the CC BY-NC-ND license (http://creativecommons.
org/licenses/by-nc-nd/4.0/).

1. Introduction orbital fracture management, compared it with traditional tech-

Orbital fracture management has been influenced by the
development of 3D technologies in the last three decades
(Bittermann et al., 2014; Visscher et al., 2016; Fuessinger et al.,
2019). Among the most important innovations is the application
of patient-specific implants (PSIs), which was proposed as an
alternative for conventional reconstructive plates in order to ach-
ieve precise and predictable reconstruction of the complex orbital
anatomy. Numerous studies have evaluated the efficacy of PSIs in
* Corresponding author.
E-mail address: 80667788837@ukr.net (Y. Chepurnyi).
niques, and described the algorithms of computer-aided design
(CAD) and clinical application (Gander et al., 2014; Zimmerer et al.,
2016; Chepurnyi et al., 2020; Rana et al., 2019; Ka €rkk€
ainen et al.,
2018; Falkhausen et al., 2021). However, the design and
manufacturing of PSI have been recognised as time-consuming
processes, requiring the close collaboration of surgeons and bio-
engineers. The often complicated logistics and communication
relating to PSIs have been noted in the literature as among the main
disadvantages of the approach (Wagner et al., 2015; Gander et al.,
2014; Zimmerer et al., 2018; Osaki T, 2020; Chepurnyi et al., 2020c).
In general, the CAD procedures for orbital reconstruction with
PSIs include: 1) acquiring the virtual orbital model, with restored
walls; 2) determination of the PSI borders and shape; and 3)

https://doi.org/10.1016/j.jcms.2022.05.006
1010-5182/© 2022 The Authors. Published by Elsevier Ltd on behalf of European Association for Cranio-Maxillo-Facial Surgery. This is an open access article under the CC BY-
NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Y. Chepurnyi, O. Zhukovtseva, A. Kopchak et al.
creation of the virtual model, which could be used for further
manufacturing. Thus, PSI design requires virtual restoration of the
orbital walls, based on segmentation of computed tomography (CT)
data (Noser et al., 2010; Gander et al., 2014; Chepurnyi et al., 2020b;
Rana et al., 2019). The CT segmentation is exceptionally important
for creation of a true-to-original or desired orbital shape, integrity
of the orbital walls, and further precise orbital reconstruction
(Wagner et al., 2015; Fu et al., 2017; Fuessinger et al., 2019). How-
ever, orbital walls are complicated structures, with low thicknesses
that may cause their misrepresentation on the conventional CT, and
therefore require special approaches for segmentation (Essig et al.,
2013; Wagner et al., 2015; Visscher et al., 2016). Such artificial de-
fects, as well as the true defects of the orbital walls caused by
trauma, should be eliminated by editing of the virtual model of the
orbit, before creating the PSI design (Wagner et al., 2015;
Visscheret al., 2016).
There are several methods currently used for orbit segmenta-
tion, including manual (‘slice-by-slice’), atlas-based, and model-
based methods, each with different levels of involvement of spe-
cialists in the process (Wagner et al., 2015; Visscher et al., 2016;
Jansen et al., 2015; Nilsson et al., 2018; Chepurnyi et al., 2020).
‘Slice-by-slice’ segmentation has been considered the most precise
method. However, according to the literature, this method is time-
consuming and is recommended by most of the authors only as an
option for complicated cases. Additionally, it requires close
collaboration between surgeon and bioengineer to achieve the
appropriate virtual anatomy before launching PSI design proced-
ures (Spalthoff et al., 2019; Rana et al., 2019).
On the other hand, the model-based method permits automatic
or semi-automatic orbital segmentation in the software environ-
ment, reducing the length of time required for the procedure
(Wagner et al., 2015; Visscher et al., 2016; Jansen et al., 2015; Fu
et al., 2017; Nilsson et al., 2018; Chepurnyi et al., 2020,2020b;
Taghizadeh et al., 2019). However, the sensitivity of automated
segmentation and virtual orbital wall repair in different orbital
trauma patterns, as well as the limitations of their clinical appli-
cation, require further investigation.
The study aimed to compare automated and manually con-
ducted (slice-by-slice) virtual orbital wall reconstruction in terms
of PSI design, manufacture, and clinical application for orbital
fracture management.
2. Materials and methods
This prospective comparative study was based on the analysis of
clinical manifestations and CT data of patients, who underwent
orbital reconstructions at the Kyiv Regional Hospital and Kyiv
Emergency Hospital, Ukraine. The study was approved by the Ethics
Committee of the O.O. Bohomolets National Medical University (No.
126, November 13, 2019) and met the requirements of the Decla-
ration of Helsinki. Written, informed consent was obtained from all
individual participants enrolled in the study.
Inclusion criteria for the study were: 1) isolated unilateral
orbital fracture of the orbital floor and/or medial wall; 2) orbital-
wall reconstruction with PSI; and a follow-up period of at least 3
months. Exclusion criteria were: 1) anophthalmos; 2) age <18
years; 3) injury of the globe that restricted surgical reconstruction
(e.g. retinal detachment or globe rupture); 4) total loss of vision in
one or both eyes; 5) neurological disease that influenced eye
motility or vision; 6) history of radiation or chemotherapy; 7)
mental illness; 8) lack of interaction with a physician during the
postoperative period, or non-compliance with medical recom-
mendations; 9) absent or low-quality CT scan before or after sur-
gery; 10) patient refusal to participate in the study; 11) any of the
following orbital fracture patterns e trap-door fractures, orbital
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Journal of Cranio-Maxillo-Facial Surgery 50 (2022) 686e691
fractures associated with zygoma or maxilla fractures, or extensive
damage to the orbital floor and medial wall, with total involvement
of the apical part.
Patients were randomly divided into two groups, with no sta-
tistically significant differences in age, sex, or fracture type distri-
bution e these were checked afterwards (Table 1). Randomization
was conducted by applying a computer-assisted random number
generator, with patients assigned to the main or control group ac-
cording to even number or odd number, respectively. The main
group comprised patients where automatic virtual orbital recon-
struction was applied for PSI design. The control group comprised
patients where a manual segmentation algorithm was used for PSI
design. The patients in both groups were operated on by the same
two senior surgeons, who were unaware of the method of PSI
design used.
In the main group, DICOM files of the CT data were imported to
Disior Bonelogic® CMF Orbital Analysis Software (Helsinki,
Finland), which converted them into voxel maps and performed a
three-dimensional rendering of the craniofacial bone structures,
using threshold settings. Next, the software segmented the orbits
and automatically performed a virtual reconstruction of the orbital
wall using the model-based method. Thus it was able to determine
the wall defects caused by orbital fracture, and measure the defect
square and prolapsed soft-tissue volume. To restore these regions,
the software automatically superimposed the mirrored, intact
orbital model and renewed the surface of the damaged one. Next,
the bioengineers evaluated the quality of the reconstructed surface
of the damaged orbit, and its applicability for PSI design, according
to the demands and suggestions of the surgeons. Approved virtu-
ally reconstructed orbits then underwent further CAD procedures.
In the control group, virtual reconstruction of the orbital walls
was performed using slice-by-slice segmentation. To perform such
a reconstruction, DICOM files of the CT data were imported to the
CAD software (D2P, v.1.0.2.53, Simbionix Ltd/3D Systems Inc., Beit
Golan, Israel), from which virtual orbital models were obtained
using threshold settings. Further orbital wall surface reconstruction
was conducted using slice-by-slice segmentation, and edited ac-
cording to the contours of the mirrored and superimposed virtual
model of the intact orbit.
The CAD/CAM procedures used for PSI design were the same for
both group e STL files of the virtually reconstructed orbit were
exported to CAD software (Geomagic Freeform Plus, Rock Hill,
South Carolina, USA). Further processing of the model included
wrapping, smoothing, and fixing procedures. The implant design
was obtained by creating the required shape of the surface, and
subsequently transforming it into an object with a defined thick-
ness. Next, clearance of the object and the creation of holes for
fixation were performed using Boolean operations. After validation
and correction by clinicians, the STL file was sent to the manufac-
turer (Imateh Medical Ltd., Kyiv, Ukraine) (Fig. 1).
All patients in both groups were examined preoperatively, on
the first day after surgery, and at 1 and 6 months after surgery,
following a standardized algorithm, including local status exami-
nation (facial symmetry, Hertel exophthalmometry), and evalua-
tion of visual acuity, double vision, and ocular motility (the ‘follow-
my-finger’ test). Visual fields were also recorded. Orbital wall de-
fects were classified according to the ‘Arbeitsgemeinschaft für
Osteosynthese fragen, cranio-maxillo-facial’ (AOCMF) classification
system (Kunz et al., 2014). The position of the PSI was evaluated,
based on CT scans after surgery, in line with the study by Zimmerer
et al. (2018). The evaluation criteria for determining the clinical
success rate were: 1) comparing the degree of residual enoph-
thalmos in each group (enophthalmos was considered if absolute
values were less than 14 mm by Hertel's test, or there was a dif-
ference of more than 2 mm between both eyes); 2) assessing the
Y. Chepurnyi, O. Zhukovtseva, A. Kopchak et al. Journal of Cranio-Maxillo-Facial Surgery 50 (2022) 686e691

Table 1
Demographical and orbital wall fracture distribution.

Clinical condition Main group n ¼ 23 Control group n ¼ 27 p-value

Sex distribution n ¼ 17 n ¼ 22 p ¼ 0.764b

Males n¼6 n¼5
Females
Mean age (years) 36.5 ± 17.0 40.4 ± 15.7 0.273a
Orbital wall fracture distribution: n ¼ 12 n ¼ 15 p ¼ 0.81b
W1(i)2(i) n¼9 n¼8 p ¼ 0.480b
W1(im)2(im) n¼3 n¼4 p ¼ 1.000c
W2(i)A(i)
a
Mann-Whitney U test.
b
Pearson's chi-squared test.
c
Fisher's exact test.

Fig. 1. PSI design, based on automated virtual orbital wall reconstruction: (a) orbital fracture, initial condition; (b) automatically reconstructed orbital floor in CAD software; (c) PSI
design; (d) validation of the PSI position inside the orbit.

orbital volume between the intact and reconstructed orbits; 3) the
presence of double vision; and 4) implant malposition. In addition,
the time spent on CAD procedures, the duration of the surgical
intervention, and early (1 month after surgery) and long-term
postoperative complications (6 months after surgery) were
evaluated.
Indications for orbital reconstruction in all cases of the main and
control groups were orbital wall fractures associated with double
vision. The patients of both groups underwent a standardized
surgical procedure of orbital reconstruction with PSIs. A trans-
conjunctival approach was used in cases of isolated orbital floor
fractures; involvement of the medial orbital wall, or the presence of

688
Y. Chepurnyi, O. Zhukovtseva, A. Kopchak et al.
two wall fractures, was managed via a subciliary approach. The
surgical procedure included repositioning of the prolapsed soft
tissue content followed by PSI placement, without intraoperative
navigation. PSIs in all cases of main and control groups were fixed
to the orbital rim with two 5 mm screws (Titamed BVBA Alpha). The
positioning of the screw holes was determined by the existing
clinical conditions and suggestions of the surgeon.
Postoperative CT scans of all patients were imported to Disior
Bonelogic® CMF Orbital Analysis Software (Helsinki, Finland),
where orbital shape and orbital volume differences between the
intact and reconstructed orbits were measured. To determine shape
differences, the software's automatic superimposition feature was
used for ‘point-to-point’ comparisons between reconstructed
orbital models and mirrored intact orbital models. The software
indicated areas of discrepancy in colour and presented these as
percentages.
Statistical analysis of the data included the calculation of means
and standard deviations for the evaluated parameters. Non-
parametric tests were used for analysis. The Mann-Whitney U
test and Fisher's exact test were used to compare the differences
between groups. The level of significance was set at p < 0.05. To test
for interobserver and intraobserver agreement for all measure-
ments, the intraclass correlation coefficient (ICC) and 95% confi-
dence interval (CI) were measured for orbital volume and orbital
shape estimation. Calculations were performed using SPSS statis-
tics software (IBM, USA).
3. Results
The mean age of the patients enrolled in the study was 35.8 ± 13.4
years (range 18e70 years old). Comparing the results of the main
(n ¼ 23) and control (n ¼ 27) groups, the mean volume differences
between the intact and reconstructed orbits were 0.65 ± 0.26 cm3
and 0.57 ± 0.23 cm3, respectively (p ¼ 0.837). No cases of enoph-
thalmos after surgery were detected in either group. Orbital shape
differences were similar for both groups, at 3.3 ± 3.5% and
3.25 ± 2.5%, respectively (p ¼ 0.929). No cases of implant malposition
were observed in either group. However, at the 3-month follow-up,
double vision was diagnosed in several cases: three in the main
group and three in the control group (p ¼ 0.651). Other clinical pa-
rameters and complication rates are shown in Table 2.
The average time spent for CAD procedures, including segmen-
tation and virtual orbital reconstruction, was 36.7 ± 6.9 min for the
main group and 72.9 ± 7.7 min for the control group (p < 0.001). The
average period from ordering the PSI to its delivery to the hospital
was less than 3 days for both groups. The average duration of surgery
was 57.5 ± 14.7 min for the main group and 58.3 ± 11.3 min for the
control group (p ¼ 0.633). No cases of PSI correction, its rejection
during surgery, or implant incongruity to orbital anatomy were
observed in either group. The intraobserver and interobserver ICCs
for all modes of segmentation are shown in Table 3.
Table 2
Summary of clinical outcomesa.
Clinical condition
Orbital volume difference
Orbital shape difference
Double vision
Motility impairment
Mydriasis
Infraorbital sensory disturbance
Enophthalmos, wound infection, sinus inflammation, implant malposition, decreased/lost vision
a
3-month follow-up.
b
Mann-Whitney U test.
c
Fisher's exact test.
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Journal of Cranio-Maxillo-Facial Surgery 50 (2022) 686e691
4. Discussion
Orbital reconstruction using PSIs has become an effective,
evidence-based treatment option in recent decades (Bittermann
et al., 2014; Zimmerer et al., 2016; Rana et al., 2019; Kim et al.,
2019). The main advantage of PSIs is the restoration of precise
orbital shape and volume following surgical intervention. For these
reasons, numerous authors advocate the clinical application of PSIs
for orbital reconstruction as a routine treatment option (Rana et al.,
2019; Chepurnyi et al., 2020). However, some disadvantages of PSIs,
such as their time-consuming and complicated design process,
have limited the wider clinical application of this technique.
Nonetheless, PSIs have become a preferable solution for managing
complicated cases of orbital fractures featuring enophthalmos,
secondary orbital deformities, or postenucleation socket syndrome
(Dubois et al., 2015; Mommaerts et al., 2016; Ka €rkka
€inen et al.,
2018; Spalthoffet al., 2018; Wilde et al., 2019).
PSI design and manufacturing are based on the virtually
reconstructed ‘true-to-original’ anatomy of the orbit. Usually, this is
the most time-consuming stage of PSI design, with extensive
involvement of the software operator, mainly for virtual model
editing (Noser et al., 2010; Wagner et al., 2015; Mommaerts et al.,
2016). When applying manual segmentation during virtual orbital
wall reconstruction, the bioengineer indicates the desirable orbital
contour of the orbit in each CT slice, which takes a significant time
for each clinical case. Several algorithms have been proposed to
simplify this procedure. Jansen et al. (2015) evaluated the capability
of the automated and semi-automated methods of atlas-based
segmentation for orbital volume measurement. They concluded
that the automated method is quick, but suboptimal for clinical use
in comparison with the semi-automated method. Wagner et al.
(2015) demonstrated that model-based orbital segmentation for
volume measurement has a precision comparable to manual and
atlas-based methods. Additionally, they indicated that this method
can provide reliable orbital segmentation in cases with poor CT
quality. Later, these authors successfully performed the first at-
tempts to apply automated virtual reconstruction of unilateral
midface defects (Wagner et al., 2015).
The results of this study show that automatic orbital segmen-
tation allows users to perform virtual orbital reconstruction more
easily and 70% faster than seen in traditional approaches. Virtually
reconstructed orbital models are exported for further PSI design in
much more acceptable conditions, without triangular mesh defects.
In general, PSI design and manufacturing in both groups of patients
in our study took less than 3 days from the time of order to delivery
to hospital. Such a timeline is acceptable for orbital fracture man-
agement in most cases.
Concerning clinical application, PSIs based on automated virtual
orbital reconstruction demonstrated results uniformly similar to
those for the control group, for which PSI design had been based on
slice-by-slice reconstruction. Both groups showed precise orbital
Main group n ¼ 23 Control group n ¼ 27 p-value
3 3
0.65 ± 0.26 cm 0.57 ± 0.23 cm p ¼ 0.837b
3.3 ± 3.5% 3.25 ± 2.5% p ¼ 0.929b
n¼3 n¼3 p ¼ 0.651c
4.3% (n ¼ 1) 0 p ¼ 0.46c
0 n¼2 p ¼ 0.493c
n¼4 n¼6 p ¼ 0.735c
0 0
Y. Chepurnyi, O. Zhukovtseva, A. Kopchak et al. Journal of Cranio-Maxillo-Facial Surgery 50 (2022) 686e691

Table 3
Intraobserver and interobserver ICCs for main and control groups.

Main group Control group

Orbital volume Intraobserver ICC 0.973 (95% CI 0.962e0.990) 0.978 (95% CI 0.964e0.989)
Interobserver ICC 0.984 (95% CI 0.976e0.993) 0.987 (95% CI 0.982e0.994)
Orbital shape Intraobserver ICC 0.975 (95% CI 0.964e0.989) 0.979 (95% CI 0.968e0.986)
Interobserver ICC 0.985 (95% CI 0.977e0.995) 0.986 (95% CI 0.978e0.993)

volume renewal, with discrepancies of less than 1 cm3. These re-
€ negg et al. (2018), and explain
sults are comparable to those of Scho
the absence of enophthalmos in both groups of patients after sur-
gery. However, in consideration of the higher importance of orbital
shape restoration, as noted by Essing et al. (2013), it was decided to
analyze orbital shape based on superimposition of the intact and
reconstructed orbital models. This analysis showed that the mean
shape differences between the intact and reconstructed orbits in
the main and control groups were 3.3 ± 3.5% and 3.25 ± 2.5%,
respectively. Such results represent a highly accurate level of
reconstruction, as a consequence of the correct positioning of PSIs,
which correlated with the preplanned positions in all cases. No
complications relating to PSI application were found in our study
(Fig. 2).
Nevertheless, numerous studies have indicated that the influ-
ence of accurate reconstruction of orbital geometry on clinical
outcomes may be overestimated in the literature. Our results
correlated with the study by Zimmerer et al. (2018), which sug-
gested that precise reconstruction is often unable to predict
complete ophthalmological recovery. Both groups in our study
demonstrated similar results regarding double vision, the fre-
quency of which was in range of 11e13%. This result calls for further
investigation of soft-tissue-related factors involved in the rehabil-
itation of orbital fracture patients.
This study had several limitations, relating to the exclusion of
some orbital trauma patterns from the evaluation. The software
used, as with similar programs, performs automatic segmentation
based on mirroring and superimposition of the orbits. This explains
the inability to perform automatic virtual reconstruction of bilat-
eral orbital wall defects, which is one limitation of this automatic
algorithm. Inadequate virtual orbital reconstruction in cases of a
totally damaged apical part of the orbital floor and orbital medial
wall e also excluded from this study e can be similarly explained.
The high risk of incorrect positioning of PSIs inside the orbit,
without apical support, contraindicated the use of automatic seg-
mentation in such cases. Some authors have proposed defining
statistically shaped orbital models, based on a large sample num-
ber, for different populations and facial anatomies, as a possible

Fig. 2. Orbital fracture management with PSI, based on automated virtual wall reconstruction (same patient): (a) 3D reconstruction; (b) axial view of reconstructed medial wall; (c)
sagittal view of supported apical part of PSI; (d) frontal view.

690
Y. Chepurnyi, O. Zhukovtseva, A. Kopchak et al.
solution for virtual reconstruction of bilateral orbital fractures.
However, an adequate solution to this problem remains far from
reality (Fuessinger et al., 2019; Taghizadeh et al., 2019; Kim et al.,
2020) Trap-door fractures were also excluded because of the soft-
ware's inability to determine the orbital wall defect, due to the
repositioning of the bony fragment immediately after fracture.
Fractured orbital margins, associated with zygoma or maxilla
fractures, required virtual repositioning before virtual orbital wall
reconstruction. Thus, such cases were also excluded from the
clinical survey.
No differences were found between groups in terms of clinical
peculiarities of PSI application. The PSIs, based on virtual orbital
reconstruction, did not negatively influence the surgical procedures
or their average durations, which were similar to that of the control
group. No additional corrections of PSIs were necessary in the main
group, making the course of the procedure highly predictable. As a
result, PSI-based orbital reconstruction, utlizing automated virtual
wall reconstruction, can be recommended as a routine procedure,
taking into account the above-mentioned limitations.
5. Conclusion
Within the limitations of the study it seems that PSI based on
automated virtual reconstruction is a relevant alternative treat-
ment option for orbital fractures because of its clinical efficacy that
is similar to PSI based on a ‘slice-by-slice’ CAD protocol.
Declaration of competing interest
The authors declare that they have no conflicts of interest.
Acknowledgement
This work was supported by a research grant from the Ministry
of Health of Ukraine (state registration number 0122U001339).
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