Computers in Biology and Medicine 137 (2021) 104791

Contents lists available at ScienceDirect

Computers in Biology and Medicine

journal homepage: www.elsevier.com/locate/compbiomed

Accuracy of free-hand positioned patient specific implants (PSI) in primary

reconstruction after inferior and/or medial orbital wall fractures
Florian Andreas Probst a, *, Carl-Peter Cornelius a, Sven Otto a, Yoana Malenova a,
Monika Probst b, Paris Liokatis a, Selgai Haidari a
a
Department of Oral and Maxillofacial Surgery and Facial Plastic Surgery, University Hospital, LMU, München, Germany
b
Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität, München, Germany

A R T I C L E I N F O A B S T R A C T

Keywords: Background: To assess the accuracy with which CAD/CAM-fabricated patient-specific titanium implants (PSI) are
Patient specific implant (PSI) positioned for inferior and/or medial orbital wall reconstruction without the use of intraoperative navigation.
Cranio-maxillofacial surgery Methods: Patients who underwent a primary reconstruction of the orbital walls with PSI due to fractures were
CAD/CAM
enrolled in this retrospective cohort analysis. The primary outcome variables were the mean surface distances
Orbital wall reconstruction
(MSD) between virtually planned and postoperative PSI position and single linear deviations in the x-, y- and z-
Traumatology
axis at corresponding reference points. Secondary outcome variables included demographic data, classification of
orbital wall defects and clinical outcomes.
Results: A total of 33 PSI (orbital floor n = 22; medial wall, n = 11) were examined in 27 patients. MSD was on a
comparable level for the orbital floor and medial wall (median 0.39 mm, range 0.22–1.53 mm vs. median 0.42
mm, range 0.21–0.98 mm; p = 0.56). Single linear deviations were lower for reconstructions of the orbital floor
compared to the medial wall (median 0.45 vs. 0.79 mm; p < 0.05). There was no association between the
occurrence of diplopia and the accuracy level (p = 0.418).
Conclusions: Free-hand positioning of PSI reaches a clinically appropriate level of accuracy, limiting the necessity
of navigational systems to selected cases.

1. Introduction
Fractures of the orbital floor and/or medial orbital wall are among
the most common fractures of the facial skeleton and, due to their
clinical sequelae, may be associated with potentially serious functional
and esthetic complications such as bulbar deformity, extraocular muscle
movement limitations, diplopia, and enophthalmos or hypoglobus [1,2].
The anatomical complexity of the orbital wall surfaces, a surgical
approach with limited field of vision and the risk of injury to the orbital
soft tissue contents such as the neurovascular supply, extraocular mus­
cles and the optic nerve are typical barriers to an exact bony recon­
struction [3]. Nevertheless, the primary goal in the treatment of orbital
wall fractures is a true to original accuracy of the reconstruction of the
bony walls [4–6]. This requirement has launched an evolution of new
implant generations for the repair of traumatic infero-medial wall
defects.
Starting with individualized manually prebent [7] and standardized
preformed titanium mesh orbital implants [8], primary orbital recon­
struction follows the current trend for PSI in cranio-maxillofacial sur­
gery with individualized selective laser melted titanium implant designs
[9–14]. The use of CAD/CAM-fabricated PSI in primary orbital recon­
struction has become common practice and is due to their accurate
adaptability to the individual surface relief of the orbital floor and/or
medial orbital wall [3,15–20]. While non-patient-specific implants have
to be shaped freehand according to the intraoperative findings and the
surgeon’s experience, PSIs can be adapted to the patient’s orbital
anatomy as part of preoperative virtual surgical planning based on CT
imaging [3,15–21]. For contouring, mirroring from the non-affected
contralateral side as a template has proven effective [22]. First clinical
outcomes studies and comparisons of the accuracy have confirmed
[17–21] the advantages of PSI in orbital wall reconstruction. Mean­
while, the use of intraoperative navigation to position PSI is suggested to
achieve optimal results [3,4,16,19].
Yet, the evaluation of previous studies predominantly relied on

* Corresponding author.
E-mail addresses: florian.probst@med.uni-muenchen.de, flo.probst@web.de (F.A. Probst).

https://doi.org/10.1016/j.compbiomed.2021.104791
Received 2 May 2021; Received in revised form 19 August 2021; Accepted 19 August 2021
Available online 27 August 2021
0010-4825/© 2021 Elsevier Ltd. All rights reserved.
F.A. Probst et al.
comparisons of the restored orbital volume and/or angular deviations
between the reconstructed orbit and the unaffected contralateral orbit
and did not consider the positioning of PSI as an independent determi­
nant. The anatomic reconstruction of the convex bulging around the
transitional zone between the orbital floor and the medial orbital wall in
the posterior midorbit is known as crucial for the sagittal and vertical
ocular globe projection and the prevention of diplopia owing to
enophthalmos and hypoglobus [23]. A mismatching shape profile may
result from topographic PSI malpositioning, with the predominant site
for complications to occur being the aforementioned convexity in the
posterior-medial midorbit [23].
In fact, the use of navigation systems to avoid inaccurate PSI place­
ment faces logistical and budgetary limitations. Consequently, this
technology is not available in every trauma center around the world.
That is why a broad spectrum of medical disciplines such as ophthal­
mology, oral and maxillofacial surgery, otolaryngology, plastic and
reconstructive surgery as well as general trauma surgery have raised the
question, whether freehand placement of ideally fitting patient-specific
implants (PSI) in orbital wall reconstruction can be performed within a
clinically acceptable range of deviation compared to the virtual position
in preoperative computer-assisted planning.
Therefore, the aim of this study was therefore to assess the accuracy
with which CAD/CAM-fabricated patient-specific titanium implants
(PSI) are positioned free-hand for reconstruction of the orbital floor and/
or medial wall. The geometric deviation between the virtually planned
and the postoperative PSI position was evaluated using the following
primary outcome variables, which represent a novel evaluation
approach for orbital implant accuracy determination: (1) three-
dimensional (3D) mean surface distances (MSD), indicating the overall
3D geometric deviation, and (2) individual linear deviations in the x-, y-
and z-axes, indicating the axial directional deviation.
2. Material and methods
2.1. Study design
The authors designed and implemented a retrospective single-center
cohort study to address the research question. The study sample was
consecutively obtained from the population of patients presenting with
inferior and/or medial orbital wall fractures at the Department of Oral
and Maxillofacial Surgery and Facial Plastic Surgery, University Hospi­
tal, Munich, Germany, from January 2015 to December 2019. The study
followed the standards for reporting observational studies (STROBE
guidelines). Subjects eligible for study inclusion underwent inferior,
medial or combined inferior and medial orbital wall reconstruction with
selective laser melted patient-specific titanium implants (PSI). Only
primary trauma interventions were included, in which the reconstruc­
tion of the orbital wall was performed within a period of four weeks after
the causative trauma event. A further inclusion criteria was the avail­
ability of high-resolution (isotropic resolution 1 mm or better) post­
operative computed tomography (CT) within two weeks after surgery.
Patients with bilateral orbital wall fractures and further ipsilateral
midface fractures were excluded from the study, as were subjects
younger than 18 years of age or those who did not return for regular
follow-up. The institutional ethics committee approved the retrospective
study protocol (Ethics Committee, Ludwig-Maximilians-University,
Munich, Germany: Ref.-No. 19–167).
2.2. Clinical workflow
The positive decision on orbital reconstruction with a CAD/CAM-
fabricated patient-specific implant was made based on clinical exami­
nation by oral and maxillofacial surgeons, consultation with the
ophthalmologist as well as review of the CT imaging. High-resolution CT
scans (isotropic resolution 0.625 mm) were performed. The resulting
DICOM data were transferred to an industrial partner (KLS Martin,
2
Computers in Biology and Medicine 137 (2021) 104791
Tuttlingen, Germany) for subsequent virtual surgical planning (VSP) in a
web-based interactive session. After final approval by the treating sur­
geon, PSI went into the computer aided manufacturing (CAM) process
by selective laser melting. The operations were performed by one group
of board-certified oral and maxillofacial surgeons, each with more than
8 years of experience in the surgical treatment of orbital fractures using
titanium implants. All PSI were placed freehand, without the use of
navigational systems or physical positioning guides. Postoperatively,
high-resolution CT scans, routine ophthalmological examination and
follow-up care in the Department of Oral and Maxillofacial Surgery and
Facial Plastic Surgery were conducted.
2.3. Study variables, data acquisition and analysis
The primary outcome variables (specified in detail below) describe
the geometric deviation between the virtually planned and the post­
operative PSI position determined by computed tomography. The
postoperative CT-scans were segmented with Mimics (Materialise,
Leuven, Belgium) differentiating soft tissue (HU < 300), bone tissue (HU
300–1000) and titanium (HU > 1500) and exported as STL-files (.stl)
into 3-matic (Materialise, Leuven, Belgium), a dedicated CAD analyzing
software. The corresponding STL-files representing the initial virtual
planning were provided by the industrial partner (KLS Martin, Tut­
tlingen, Germany) and imported as well. The midfacial bone parts of the
pre- and postoperative datasets were aligned to each other with a
semiautomatic fusion algorithm, first by a 3-point alignment procedure
prior to global alignment.
The geometric deviation between the virtually planned and the
postoperative PSI position was assessed by the two following measures,
which are the primary outcome variables (Fig. 1, Table 1):
(1) Three-dimensional (3D) mean surface distance (MSD) reported in
mm, representing the overall 3D geometric deviation. For the
measurement of the MSD, the command set "Part Comparison
Analysis (PCA)" in the software 3-matic (Materialise, Leuven,
Belgium) was used. The algorithm of the software is point-based.
Thereby, each surface point of a virtually constructed PSI was
assigned to the closest point of the corresponding postoperative
PSI model, and the respective Euclidean distances were
measured. Mean unsigned (absolute) distances (corresponding to
the “mean surface distance” according to van Eijnatten and col­
leagues 2018) were recorded [24]. Color-coded difference images
(heatmaps) visualized the localization of areas with high or low
geometric deviations. A separate evaluation determined the MSD
with regional focus on the posterior medial bulge in PSI for the
orbital floor and on the medial midorbit (approximately corre­
sponding to the area W2m of the AOCMF trauma classification) in
PSI for the medial orbital wall and
(2) Single linear deviations reported in mm in the x-, y- and z-axis at
five corresponding reference points on the virtual PSI and the post­
operative PSI model. The reference points were selected at the
implant margins of the infraorbital rim, the mid-lateral part, the mid-
medial part, the posterior part and at the implant center. The x-axis
corresponded to transverse (lateral/medial), the y-axis to sagittal
(anterior/posterior) and the z-axis to axial (cranial/caudal) align­
ment. Both unsigned (absolute) values representing the overall ac­
curacy as well as signed values representing under or over correction
were registered. Deviations of the postoperative implant position in
lateral, anterior and cranial direction were defined as positive (+)
value. Accordingly, deviations in the medial, posterior and caudal
directions were referred to as negative (− ) values.
Secondary outcome variables (Table 2) included demographic data
(age, sex), type of defect according to the orbital module of the AO CMF
Trauma Classification (AOCMFTC), PSI placement area (orbital floor
and/or medial orbital), time from trauma to surgery, type of surgical
F.A. Probst et al. Computers in Biology and Medicine 137 (2021) 104791

Fig. 1. Data analysis. (A) Segmentation procedure. (B) Alignment of midfacial bone parts of a pre- and postoperative dataset to each other. (C) Virtually planned PSI
position (grey) and postoperative PSI position (blue). (D) Color-coded difference image (heatmap) and histogram displaying geometric deviations (3D mean surface
distance, MSD). (E) Reference points on an orbital floor PSI (Top left) and a medial wall PSI (Bottom left) and assignment of the x-, y- and z-axis to different di­
rections (Right).

approach, duration of surgery, and need for revision surgery (yes/no).

Table 1A Moreover, unfavorable clinical outcomes still present 12 weeks post­
3D Mean surface distances (MSD).
operatively, i. e. persistent diplopia and/or differences in globe height
3D mean surface distance (MSD) and/or globe projection of more than 2 mm, were recorded following the
Overall PSI – Overall PSI – Posterior Medial definition of Zimmerer and colleagues 2018 [25].
Orbital floor Medial orbital medial bulge midorbit area
wall (W2m)
2.4. Statistical analysis
N 22 11 22 11
Median 0.39 mm 0.42 mm 0.29 mm 0.33 mm
interquartile 0.33 mm 0.47 mm 0.32 mm 0.53 mm Statistical analysis was carried out with Excel (Microsoft, Redmond,
range USA), SPSS 26 (SPSS Inc., Chicago, USA) and Python (Wilmington,
Range 0.22–1.53 0.21–0.98 mm 0.12–2.65 0.15–1.02 Delaware, USA). Descriptive statistics were performed for each study
mm mm mm
variable. Intraclass correlation (ICC) assessed intra- and inter-rater
agreement (two observers, repetition after 6 weeks) in terms of single

Table 1B
Unsigned (absolute) linear deviations in the x-, y- and z-axis at five corresponding reference points.
Unsigned (absolute) linear deviations

Orbital floor Medial orbital wall

x-axis (lateral/ y-axis (anterior/ z-axis (cranial/ All axes x-axis (lateral/ y-axis (anterior/ z-axis (cranial/ All axes
medial) posterior) caudal) combined medial) posterior) caudal) combined

N 110 110 110 330 55 55 55 165

median 0.79 mm 0.44 mm 0.30 mm 0.45 mm 0.41 mm 1.26 mm 0.83 mm 0.79 mm
interquartile 0.98 mm 0.70 mm 0.41 mm 0.73 mm 0.80 mm 1.21 mm 0.85 mm 1.12 mm
range
range 0.00–3.42 mm 0.01–2.83 mm 0.00–3.28 mm 0.00–3.42 mm 0.01–5.39 mm 0.03–3.78 mm 0.03–3.62 mm 0.01–5.39 mm
95th percentile - - - 2.03 mm - - - 3.18 mm

Table 1C
Signed (±) linear deviations in the x-, y- and z-axis at five corresponding reference points.
Signed (±) linear deviations

Orbital floor Medial orbital wall

x-axis lateral y-axis anterior z-axis cranial x-axis lateral y-axis anterior z-axis cranial
(+)/medial(− ) (+)/posterior(− ) (+)/caudal(− ) (+)/medial(− ) (+)/posterior(− ) (+)/caudal(− )

N 110 110 110 55 55 55

median 0.36 mm 0.09 mm 0.20 mm 0.15 mm 0.29 mm 0.62 mm
interquartile 1.65 mm 0.91 mm 0.54 mm 0.87 mm 2.31 mm 1.01 mm
range
range − 3.42 – 2.68 mm − 2.58 – 2.83 mm − 1.11 – 3.28 mm − 5.39 – 2.62 mm − 2.44 – 3.78 mm − 1.17 – 3.62 mm

3
F.A. Probst et al. Computers in Biology and Medicine 137 (2021) 104791

Table 2 MSD values were 0.29 mm and 0.33 mm (p = 0.925) (Fig. 2B, Table 1A).
Demographic characteristics and further secondary outcome variables.
Demographic/secondary outcome 3.2. Unsigned (absolute) linear deviations
Sex Female n=5
Male n = 22 For the orbital floor, unsigned (absolute) linear deviations (median
Age Mean 45.1 years values) between the planned and the postoperative implant position
PSI placement area Inferior wall n = 22 were 0.79 mm in the x-axis, 0.44 mm in the y-axis and 0.30 mm in the z-
Medial wall n = 11
axis (p < 0.05, Friedman test)(Fig. 2C, Table 1B). Across all axes (x-, y-
AO CMF Trauma Classification W1i and W2i n = 16
W1m n=1 and z-axis, orbital floor) median was 0.45 mm and 95th percentile was
W1m and W2m n=4 2.03 mm (Fig. 2D, Table 1B).
W1i, W2i, W1m and W2m n=6 With respect to the medial orbital wall, unsigned (absolute) linear
Time from trauma to surgery Mean 8.7 days deviations (median values) were 0.41 mm in the x-axis, 1.26 mm in the
Surgical approach Transconjunctival n = 15
Transcutaneous n = 12
y-axis and 0.83 mm in the z-axis with statistically significant differences
Operation time Mean 87 min observed between the x- and the y-axis and between the x- and the z-axis
Revision surgery (yes/no) Yes n=0 (p < 0.05, Friedman test)(Fig. 2C, Table 1B). Across all axes (x-, y- and z-
No n = 27 axis, medial wall) median was 0.79 mm and 95th percentile was 3.18
Unfavorable clinical outcome Diplopia n=2
mm (Fig. 2E, Table 1B). The single unsigned linear deviations across all
(exceeding 12 weeks postoperatively) Globe height/projection n=0
axes were lower for PSI of the orbital floor compared to the medial wall
(median 0.45 vs. 0.79 mm, p < 0.05).
linear deviations in the x-, y- and z-axis at the five corresponding
reference points. Data distribution (Kolmogorov-Smirnov-Test, Shapiro- 3.3. Signed linear deviations
Wilk-Test) was not homogeneous. Therefore, data were processed using
the median, range, interquartile range as well as nonparametric testing Concerning the orbital floor, signed linear deviations (median
(Mann-Whitney-U test, Friedman test, one-sample Wilcoxon test). values) between the planned and the postoperative implant position
Fisher’s exact test was used to detect dependence between the presence were 0.36 mm in the x-axis, 0.09 mm in the y-axis and 0.20 mm in the z-
of an unfavorable clinical outcome and the accuracy level of PSI posi­ axis (p < 0.05, Friedman test) (Fig. 2F, Table 1C). The deviation in the z-
tioning, defined as overall 3D geometric deviation exceeding 1 mm. In axis was statistically different from 0 (p < 0.05), the deviations in the x-
general, the significance level was set at p = 0.05. axis and y-axis were statistically not different from 0 (p = 0.115/0.605).
With respect to the medial wall PSI, signed linear deviations (median
3. Results values) were 0.15 mm in the x-axis, 0.29 mm in the y-axis and 0.62 mm
in the z-axis (p < 0.05, Friedman test) (Fig. 2F, Table 1C). The deviations
The study sample included 27 patients (5 female, 22 male: 18; in x-axis and z-axis were statistically different from 0 (p < 0.05), the
average age: 45.1 years). A total of 33 PSI (in six patients two PSI were deviations in the y-axis were statistically not different from 0 (p =
inserted) were used for reconstruction of the following orbital walls: 0.162).
orbital floor (n = 22), medial orbital wall (n = 11). Results of the secondary outcome variables are summarized in
Intraclass correlation (ICC) assessing intra-observer reliability of Table 2. No revision operations were carried out. Two patients presented
single linear deviations was 0.999 (orbital floor) and 0.989 (medial with unfavorable clinical outcomes in terms of persistent diplopia still
wall), inter-observer reliability was 0.967 (orbital floor) and 0.983 present after 12 weeks postoperatively. Fisher’s exact test did not detect
(medial wall). a statistically significant association (p = 0.418) between accuracy level
of PSI positioning and presence of unfavorable clinical outcome
3.1. Mean surface distances (MSD) (diplopia, n = 2).

Median overall MSD values between planned and postoperative PSI 4. Discussion
position were 0.39 mm for the orbital floor and 0.42 mm for the medial
orbital wall (p = 0.56) (Figs. 2A and 3, Table 1A). With respect to the The aim of this study was to assess the accuracy with which CAD/
posterior medial bulge and the medial midorbit area (W2m), the median CAM-produced patient-specific titanium implants (PSI) used for the

Fig. 2A. Overall 3D mean surface distances (MSD) between planned and postoperative PSI position. Orbital floor (left boxplot; n = 22, median 0.39 mm, range
0.22–1.53 mm) and medial orbital wall (right boxplot; n = 11, median 0.42 mm, range 0.21–0.98 mm).

4
F.A. Probst et al. Computers in Biology and Medicine 137 (2021) 104791

Fig. 2B. 3D mean surface distances (MSD) between planned and postoperative PSI position with respect to the posterior medial bulge (left boxplot; n = 22, median
0.29 mm, range 0.12–2.65 mm mm) and the medial midorbit area (right boxplot; n = 11, median 0.33 mm, range 0.15–1.02).

Fig. 2C. Unsigned (absolute) linear deviations in the x-, y- and z-axis of corresponding reference points between the planned and the postoperative PSI of the orbital
floor (left boxplots) and the medial orbital wall (right boxplots).

Fig. 2D. Histogram showing distribution of unsigned/absolute linear deviations in the x-, y- and z-axis across all axes between the planned and the postoperative PSI
of the orbital floor (n = 330, median 0.45 mm, range 0.00–3.42 mm, 95th percentile 2.03 mm). The red vertical dashed lines indicate the 2 mm deviation cut-off.

5
F.A. Probst et al. Computers in Biology and Medicine 137 (2021) 104791

Fig. 2E. Histogram showing distribution of unsigned/absolute linear deviations in the x-, y- and z-axis across all axes between the planned and the postoperative PSI
of the medial orbital wall (n = 165, median 0.79 mm, range 0.01–5.39 mm, 95th percentile 3.18 mm). The red vertical dashed lines indicate the 2 mm deviation
cut-off.

Fig. 2F. Signed (±) linear deviations (indicating the direction of the deviation) in the x-, y- and z-axis of corresponding reference points between the planned and the
postoperative PSI of the orbital floor (left boxplots) and the medial orbital wall (right boxplots).

Fig. 3A. Medial orbital wall reconstruction with high PSI positioning accuracy (MSD of overall PSI 0.29 mm and of medial midorbit 0.24 mm). (Left) Superim­
position of virtually planned PSI position (grey) and postoperative PSI position (blue). (Right) Representative coronary views of the postoperative CT.

reconstruction of the orbital floor and/or medial wall can be positioned
without the use of intraoperative navigation. 3D mean surface distances
between the virtual target position and the final postoperative position
of the PSI was on a low level for both the orbital floor and the medial
wall. Compared to the overall geometric deviations, single linear de­
viations in the x-, y- and z-axis were in general higher with a significant
difference between the orbital floor and the medial wall. No association
between patients presenting with persistent unfavorable clinical out­
comes and accuracy of PSI placement was evident. The results of this
study show that the position of the PSI was transferred into the operation
with a clinically reasonable level of accuracy and suggest that PSI can be
reliably placed freehand.
PSI are increasingly used in routine clinical practice because they
facilitate the true to original restoration of the individual surface relief
of orbital walls and thus meet esthetic and functional aspects [3,15–20].
However, minor inaccuracies result from contouring based on a mir­
roring technique due to small differences between right and left orbital
volume and contour [22]. In order to actually restore the relief

6
F.A. Probst et al.
accurately, it is crucial to place these PSI as precisely as possible in the
position where they were planned in the virtual setting. This is a general
demand wherever PSI are employed, such as orthognathic surgery or
reconstructive surgery [9,11,13,14]. To accurately restore the relief, it is
crucial to place the PSI exactly in the position that was intended in the
virtual setting. For this purpose, various tools such as intraoperative
navigation, positioning aids or intraoperative imaging are basically
available. Intraoperative imaging is invasive and cannot be repeated any
number of times. Surgical guides are physical aids that help transferring
the virtual planning into the surgical site. At present, it is common to
pre-drill PSI holes using drilling guides to code the PSI position [9,11,13,
14]. However, disadvantages include uncertainties regarding the intra­
operative alignment on the bony surface according to the virtual
planning.
A navigation system is typically used in studies on PSI for orbital wall
reconstruction [3,4,16,19,20]. A prospective multicenter study
demonstrated that the use of intraoperative navigation had a positive
impact on the accurate reconstruction of orbital volume [4]. The ma­
jority of studies rely on volume differences and/or angular deviations
compared to the unaffected contralateral orbit to quantify the outcome
of PSI-based orbital reconstruction [3,4,19–21]. Yet, these methods are
not amenable to provide any conclusive information on the influence of
the implant position as an independent determinant.
The primary outcome variable MSD in our study assesses the
Euclidean distances between all surface points of the virtually con­
structed PSI and the respective nearest points of the postoperative PSI
model. This measure is an established method of measuring distances
between surfaces of 3D models [24]. It provides a technically robust
statement about the overall agreement between virtually designed PSI
and the postoperative result in a single value. To obtain a more detailed
insight into the directions of deviation, we determined single linear
deviations in the x-, y- and z-axis at selected reference points as an
additional outcome variable. In contrast to the overall deviation mea­
sure (MSD), the manual assessment of discrepancies between single
landmarks is more prone to individual rater errors, yet intraclass cor­
relation (ICC) showed substantial intra- and inter-rater agreement in this
study.
In our cohort, MSD did not exceeded a level of 1.5 mm, which seems
clinically acceptable compared to commonly assumed navigation and
calibration errors approximately between 1 and 2 mm [26–29]. In
comparison, the individual linear deviations in the x-, y- and z-axes lay
at a higher level and showed significantly greater deviations at the
medial wall than at the orbital floor.
7
Computers in Biology and Medicine 137 (2021) 104791
Fig. 3B. Orbital floor reconstruction
featuring the lowest PSI positioning accu­
racy in this study (MSD of overall PSI 1.53
mm and of posterior medial bulge 2.65 mm).
The posterior part of the PSI was positioned
too far caudally. (Top left and bottom left)
Superimposition of virtually planned PSI
position (grey) and postoperative PSI posi­
tion (blue). (Top right) Color-coded differ­
ence image (heatmap) displaying geometric
deviations. (Bottom right) Representative
sagittal and coronary postoperative CT
slices.
Orbital floor PSI showed the highest unsigned (absolute) deviations
in the x-axis (lateral/medial direction), presumably due to uncertain
transversal positioning along the infraorbital rim. To address this
problem, transfer aids such as intraoperative navigation might be
helpful. Medial wall PSI showed significantly larger deviations in the z-
axis (cranial/caudal direction) and y-axis (anterior/posterior direction)
compared to the x-axis (lateral/medial direction) as medial movements
are limited by intact parts of the medial orbital wall. This effect seems to
be analogous for the orbital floor, since here the deviations in the z-axis
(cranial/caudal direction) may be lower due to movement limitations by
parts of the underlying orbital floor. The observation that the implants
were slightly elevated from the corresponding underlying wall is also
consistent with the results of the signed values. Here, orbital floor im­
plants showed significantly positive values in the cranial direction (z-
axis, median +0.20 mm) and medial wall implants showed significantly
positive values in the lateral and cranial directions (x-axis, median
+0.15 mm; z-axis, median +0.62 mm). In an individual case with a
medial orbital wall reconstruction, deviations of more than 5 mm in the
medial direction were found (negative values in the x-axis). Possibly,
such larger deviations may be prevented by the use of navigation sys­
tems. There are currently no studies on the concrete positioning accu­
racy of PSI. Against this background, our study offers orienting reference
values for further research. For other indications in which PSI are used
such as orthognathic surgery, reconstruction of posttraumatic midfacial
deformities or mandibular reconstruction, only data describing the ac­
curacy of positioning bone fragments are available [13,14,30–32].
Interestingly, within the limitations of this study there was no cor­
relation between the positioning accuracy and the presence of unfa­
vorable clinical outcomes (persistent diplopia in two patients). It was
reported that the relationship of the accuracy of orbital wall recon­
struction and the clinical outcome appears less strict than previously
thought [25], since the periorbital soft tissues may contribute to post­
operative function and appearance as confounding factor.
A weakness of the present study is its retrospective study design
limiting in particular a detailed consideration of the clinical outcome.
The lack of a control group using a positioning aid such as a navigational
system is a further limitation. Our results should be validated by a
prospective randomized controlled trial comparing freehand placement
to navigated positioning of PSI. Concerning the data analysis of the
geometric deviations, limitations may include: (1) inaccuracies in image
processing such as segmentation of bone and the PSI and alignment of
midfacial bone parts of pre- and postoperative datasets to each other
(Fig. 1a and b), and (2) inaccuracies in analysis of the geometric
F.A. Probst et al.
deviations due to inter- and intra-observer errors. These limitations may
be addressed by increasing the resolution of CT scans, using patient-
specific local HU thresholds for orbital bone, or even by automated
image processing and segmentation, e.g., based on convolutional neural
networks (CNN) [24,33,34].
5. Conclusion
Virtual surgical planning with subsequent CAD/CAM-fabrication of
patient-specific implants (PSI) for the reconstruction of the orbital floor
and/or medial wall can be accurately placed freehand into the surgical
site in a majority of cases. The use of a navigation system does not
appear to be a mandatory requirement. However, positioning may be
further improved by the use of navigation systems in particular indi­
vidual cases.
Author contributions
FAP and SH contributed to the study conception and design, to data
acquisition, to data analysis and interpretation, and to the writing and
revision of the manuscript. CPC contributed to the study conception and
design, to data analysis and interpretation, and to the writing and
revision of the manuscript. YM and PL contributed to data acquisition, to
data analysis and interpretation, and to the revision of the manuscript.
SO and MP contributed to the study conception and design, and to the
writing and revision of the manuscript. All authors reviewed and
approved the final version of the manuscript and agreed to be
accountable for all aspects of work ensuring integrity and accuracy.
Funding information
This research received no external funding.
Declaration of competing interest
The authors declare no conflict of interest.
Acknowledgements
We would like to thank KLS Martin for providing the preoperative
planning data.
References
[1] J.W. Shin, J.S. Lim, G. Yoo, J.H. Byeon, An analysis of pure blowout fractures and
associated ocular symptoms, J. Craniofac. Surg. 24 (2013) 703–707.
[2] M.S. Gart, A.K. Gosain, Evidence-based medicine: orbital floor fractures, Plast.
Reconstr. Surg. 134 (2014) 1345–1355.
[3] T. Gander, H. Essig, P. Metzler, D. Lindhorst, L. Dubois, M. Rucker, P. Schumann,
Patient specific implants (PSI) in reconstruction of orbital floor and wall fractures,
J. Cranio-Maxillo-Fac. Surg. 43 (2015) 126–130.
[4] R.M. Zimmerer, E. Ellis 3rd, G.S. Aniceto, A. Schramm, M.E. Wagner, M.P. Grant,
C.P. Cornelius, E.B. Strong, M. Rana, L.T. Chye, A.R. Calle, F. Wilde, D. Perez,
F. Tavassol, G. Bittermann, N.R. Mahoney, M.R. Alamillos, J. Basic, J. Dittmann,
M. Rasse, N.C. Gellrich, A prospective multicenter study to compare the precision
of posttraumatic internal orbital reconstruction with standard preformed and
individualized orbital implants, J. Cranio-Maxillo-Fac. Surg. 44 (2016) 1485–1497.
[5] E.B. Strong, S.C. Fuller, D.F. Wiley, J. Zumbansen, M.D. Wilson, M.C. Metzger,
Preformed vs intraoperative bending of titanium mesh for orbital reconstruction,
Otolaryngol. Head Neck Surg. 149 (2013) 60–66.
[6] G.J. Harris, Avoiding complications in the repair of orbital floor fractures, JAMA
Facial Plast Surg 16 (2014) 290–295.
[7] H. Essig, L. Dressel, M. Rana, M. Rana, H. Kokemueller, M. Ruecker, N.C. Gellrich,
Precision of posttraumatic primary orbital reconstruction using individually bent
titanium mesh with and without navigation: a retrospective study, Head Face Med.
9 (2013) 18.
[8] P. Scolozzi, A. Momjian, J. Heuberger, E. Andersen, M. Broome, A. Terzic,
B. Jaques, Accuracy and predictability in use of AO three-dimensionally preformed
titanium mesh plates for posttraumatic orbital reconstruction: a pilot study,
J. Craniofac. Surg. 20 (2009) 1108–1113.
[9] C.P. Cornelius, W. Smolka, G.A. Giessler, F. Wilde, F.A. Probst, Patient-specific
reconstruction plates are the missing link in computer-assisted mandibular
8
Computers in Biology and Medicine 137 (2021) 104791
reconstruction: a showcase for technical description, J. Cranio-Maxillo-Fac. Surg.
43 (2015) 624–629.
[10] R.H. Schepers, G.M. Raghoebar, A. Vissink, M.W. Stenekes, J. Kraeima, J.
L. Roodenburg, H. Reintsema, M.J. Witjes, Accuracy of fibula reconstruction using
patient-specific CAD/CAM reconstruction plates and dental implants: a new
modality for functional reconstruction of mandibular defects, J. Cranio-Maxillo-
Fac. Surg. 43 (2015) 649–657.
[11] F. Wilde, H. Hanken, F. Probst, A. Schramm, M. Heiland, C.P. Cornelius,
Multicenter study on the use of patient-specific CAD/CAM reconstruction plates for
mandibular reconstruction, Int J Comput Assist Radiol Surg 10 (2015) 2035–2051.
[12] F.A. Probst, M. Metzger, M. Ehrenfeld, C.P. Cornelius, Computer-assisted designed
and manufactured procedures facilitate the lingual application of mandible
reconstruction plates, J. Oral Maxillofac. Surg. 74 (2016) 1879–1895.
[13] M. Heufelder, F. Wilde, S. Pietzka, F. Mascha, K. Winter, A. Schramm, M. Rana,
Clinical accuracy of waferless maxillary positioning using customized surgical
guides and patient specific osteosynthesis in bimaxillary orthognathic surgery,
J. Cranio-Maxillo-Fac. Surg. 45 (2017) 1578–1585.
[14] T. Ruckschloss, O. Ristow, R. Kuhle, F. Weichel, C. Roser, K. Aurin, M. Engel,
J. Hoffmann, C. Freudlsperger, Accuracy of laser-melted patient-specific implants
in genioplasty - a three-dimensional retrospective study, J. Cranio-Maxillo-Fac.
Surg. 48 (2020) 653–660.
[15] P. Stoor, A. Suomalainen, C. Lindqvist, K. Mesimaki, D. Danielsson, A. Westermark,
R.K. Kontio, Rapid prototyped patient specific implants for reconstruction of
orbital wall defects, J. Cranio-Maxillo-Fac. Surg. 42 (2014) 1644–1649.
[16] M. Rana, M.M. Gellrich, N.C. Gellrich, Customised reconstruction of the orbital
wall and engineering of selective laser melting (SLM) core implants, Br. J. Oral
Maxillofac. Surg. 53 (2015) 208–209.
[17] J.T. Bachelet, G. Cordier, M. Porcheray, J. Bourlet, A. Gleizal, J.M. Foletti, Orbital
reconstruction by patient-specific implant printed in porous titanium: a
retrospective case series of 12 patients, J. Oral Maxillofac. Surg. 76 (2018)
2161–2167.
[18] M. Karkkainen, T. Wilkman, K. Mesimaki, J. Snall, Primary reconstruction of
orbital fractures using patient-specific titanium milled implants: the Helsinki
protocol, Br. J. Oral Maxillofac. Surg. 56 (2018) 791–796.
[19] M. Rana, H. Holtmann, M. Rana, A.N. Kanatas, D.D. Singh, C.K. Sproll, N.R. Kubler,
R. Ipaktchi, K. Hufendiek, N.C. Gellrich, Primary orbital reconstruction with
selective laser melted core patient-specific implants: overview of 100 patients, Br.
J. Oral Maxillofac. Surg. 57 (2019) 782–787.
[20] Y. Chepurnyi, D. Chernogorskyi, A. Kopchak, O. Petrenko, Clinical efficacy of peek
patient-specific implants in orbital reconstruction, J Oral Biol Craniofac Res 10
(2020) 49–53.
[21] M. Rana, C.H. Chui, M. Wagner, R. Zimmerer, M. Rana, N.C. Gellrich, Increasing
the accuracy of orbital reconstruction with selective laser-melted patient-specific
implants combined with intraoperative navigation, J. Oral Maxillofac. Surg. 73
(2015) 1113–1118.
[22] J. Jansen, L. Dubois, R. Schreurs, P.J.J. Gooris, T.J.J. Maal, L.F. Beenen, A.
G. Becking, Should virtual mirroring Be used in the preoperative planning of an
orbital reconstruction? J. Oral Maxillofac. Surg. 76 (2018) 380–387.
[23] L. Kamer, H. Noser, A. Schramm, B. Hammer, Orbital form analysis: problems with
design and positioning of precontoured orbital implants: a serial study using post-
processed clinical CT data in unaffected orbits, Int. J. Oral Maxillofac. Surg. 39
(2010) 666–672.
[24] M. van Eijnatten, R. van Dijk, J. Dobbe, G. Streekstra, J. Koivisto, J. Wolff, CT
image segmentation methods for bone used in medical additive manufacturing,
Med. Eng. Phys. 51 (2018) 6–16.
[25] R.M. Zimmerer, N.C. Gellrich, S. von Bulow, E.B. Strong, E. Ellis 3rd, M.E.
H. Wagner, G. Sanchez Aniceto, A. Schramm, M.P. Grant, L. Thiam Chye, A. Rivero
Calle, F. Wilde, D. Perez, G. Bittermann, N.R. Mahoney, M. Redondo Alamillos,
J. Basic, M. Metzger, M. Rasse, J. Dittman, E. Rometsch, K. Espinoza, R. Hesse, C.
P. Cornelius, Is there more to the clinical outcome in posttraumatic reconstruction
of the inferior and medial orbital walls than accuracy of implant placement and
implant surface contouring? A prospective multicenter study to identify predictors
of clinical outcome, J. Cranio-Maxillo-Fac. Surg. 46 (2018) 578–587.
[26] L. Dubois, S.A. Steenen, P.J. Gooris, M.P. Mourits, A.G. Becking, Controversies in
orbital reconstruction–I. Defect-driven orbital reconstruction: a systematic review,
Int. J. Oral Maxillofac. Surg. 44 (2015) 308–315.
[27] R. Schreurs, L. Dubois, A.G. Becking, T.J.J. Maal, Implant-oriented navigation in
orbital reconstruction. Part 1: technique and accuracy study, Int. J. Oral
Maxillofac. Surg. 47 (2018) 395–402.
[28] R. Schreurs, L. Dubois, J. Ho, C. Klop, L.F.M. Beenen, P. Habets, A.G. Becking, T.J.
J. Maal, Implant-oriented navigation in orbital reconstruction part II: preclinical
cadaver study, Int. J. Oral Maxillofac. Surg. 49 (2020) 678–685.
[29] I. Azarmehr, K. Stokbro, R.B. Bell, T. Thygesen, Contemporary techniques in orbital
reconstruction: a review of the literature and report of a case combining surgical
navigation, computer-aided surgical simulation, and a patient-specific implant,
J. Oral Maxillofac. Surg. 78 (2020) 594–609.
[30] T. Schouman, P. Scolozzi, Simple CT-based calculations of orbital floor fracture
defect size are not sufficiently accurate for clinical use, J. Oral Maxillofac. Surg. 73
(2015) 577.
[31] G.J.C. van Baar, T. Forouzanfar, N. Liberton, H.A.H. Winters, F.K.J. Leusink,
Accuracy of computer-assisted surgery in mandibular reconstruction: a systematic
review, Oral Oncol. 84 (2018) 52–60.
[32] T. Ruckschloss, O. Ristow, M. Muller, R. Kuhle, S. Zingler, M. Engel, J. Hoffmann,
C. Freudlsperger, Accuracy of patient-specific implants and additive-manufactured
F.A. Probst et al.
surgical splints in orthognathic surgery - a three-dimensional retrospective study,
J. Cranio-Maxillo-Fac. Surg. 47 (2019) 847–853.
[33] C.A. Neves, E.D. Tran, I.M. Kessler, N.H. Blevins, Fully automated preoperative
segmentation of temporal bone structures from clinical CT scans, Sci. Rep. 11
(2021) 116.
Computers in Biology and Medicine 137 (2021) 104791
[34] J. Minnema, M. van Eijnatten, W. Kouw, F. Diblen, A. Mendrik, J. Wolff, CT image
segmentation of bone for medical additive manufacturing using a convolutional
neural network, Comput. Biol. Med. 103 (2018) 130–139.