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British Journal of Oral and Maxillofacial Surgery xxx (2020) xxx–xxx

Use of CAD-based pre-bent implants reduces theatre time in

orbital floor reconstruction: results of a prospective study
C. von Wilmowsky a,∗ , M.G. Schwertner a , E. Nkenke b , T. Moest a , W. Adler c , T. Ebker d
a Department of Oral and Maxillofacial Surgery, University of Erlangen-Nuremberg, Glueckstrasse 11, 91054 Erlangen, Germany
b Department of Oral and Maxillofacial Surgery, University of Vienna, Waehrigner Guertel 18-20, 1090 Vienna, Austria
c Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nürnberg, Waldstrasse 6, 91054 Erlangen, Germany
d Department of Oral and Maxillofacial Surgery, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin,

Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany

Abstract

In this prospective study we evaluated the duration of insertion and the accuracy of fitting of computer-aided design (CAD)-based pre-
bent orbital floor plates compared with non-preformed orbital plates in reconstruction of the orbital floor. Thirty-six patients with unilateral
fractures of the orbital floor were included; pre-bent plates were used in 25 and non-preformed plates in 11. Preoperative computed tomography
(CT) scans were used for CAD of individualised implants. The anatomy of the affected orbit was virtually reconstructed “slice by slice”.
Individually pre-bent plates were generated using a stereolithographic model of the reconstructed orbit. The mean (SD) duration of insertion
was significantly reduced when pre-bent orbital plates were used (5.5 (5.4) min) compared with non-preformed meshes (11.1 (7.7) min).
The congruence of pre-bent plates to the infraorbital rim did not differ from that of non-preformed plates. The accuracy of fit was rated as
“accurate” in 24 cases. CAD-based individualised titanium meshes reduce theatre time compared with non-preformed orbital plates. Our
results confirm the efficacy of CAD-based pre-bent plates in reconstruction of the orbital floor.
© 2019 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Keywords: intraoperative time comparison; individually pre-bent titanium mesh; computer-aided design; orbital floor fracture; orbital floor reconstruction

Introduction used for reconstruction should be biocompatible and pli-

Almost 40% of all maxillofacial fractures affect the orbit;
fractures of the orbital floor often affect the area medial to
the infraorbital canal and result from falls, traffic accidents,
assault, or sport injuries.1–3 Various methods of reconstruc-
tion of the orbital floor have been introduced,4,5 and materials
∗ Corresponding author at: Department of Oral and Maxillofacial Surgery,
University Hospital Erlangen, Glueckstrasse 11, 91054 Erlangen, Germany.
Tel.: +49 9131 8537000; Fax: +49 9131 8534106.
E-mail addresses: cornelius.wilmowsky@uk-erlangen.de
(C. von Wilmowsky), maximilian.schwertner@yahoo.de
(M.G. Schwertner), emeka.nkenke@meduniwien.ac.at (E. Nkenke),
tobias.moest@uk-erlangen.de (T. Moest), werner.adler@fau.de
(W. Adler), tobias.ebker@charite.de (T. Ebker).
able, and should possess sufficient strength to support the
globe and orbital tissues.6 Resorbable alloplastic sheets made
of polydioxanone or polyglactin have reduced stability in
large defects and are therefore recommended only for smaller
defects (<2.5 cm2 ) or in children.7,8
Titanium meshes are composed of pure titanium, which is
highly biocompatible.9,10 Because of its extreme rigidity, the
use of titanium for implants is particularly indicated in large
and complex defects of the orbital floor,2,11,12,13 as inade-
quate reconstruction can result in orbital dystopia and lead to
functional and aesthetic complications such as diplopia and
enophthalmos or exophthalmos.7 The risk of enophthalmos
has been linked to the size of the defect, as well as the degree
of displacement of bony fragments and orbital soft tissue.4,5

https://doi.org/10.1016/j.bjoms.2019.11.020
0266-4356/© 2019 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: von Wilmowsky C, et al. Use of CAD-based pre-bent implants reduces theatre time in orbital floor
reconstruction: results of a prospective study. Br J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.bjoms.2019.11.020
YBJOM-5860; No. of Pages 6
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Accurate reconstruction of the orbital anatomy is crucial to
prevent postoperative functional or aesthetic impairment, and
the technique of computer-aided design (CAD) of individual
implants has revolutionised the field of craniomaxillofa-
cial surgery.1,2,3,7,12–16 CAD offers great versatility and has
become a routine procedure in midfacial and mandibular
reconstruction.17–19
Computed tomography (CT) or cone-beam computed
tomographic (CT) imaging data are transferred to 3-
dimensional planning software, and 3-dimensional printers
generate accurate stereolithographic 3-dimensional models
of hard tissues.20 Orbital floor plates are individually shaped
using stereolithographic models.2,3,21,22 Preoperative fabri-
cation of orbital floor meshes might affect duration of theatre
time for reconstruction of the orbital floor and could help to
reduce the complexity of the procedure itself. The objective
of this prospective study was therefore to assess the intra-
operative time required for insertion of CAD-based pre-bent
titanium meshes as well as the accuracy of fitting and the sur-
gical benefit when compared with those of non-preformed
titanium meshes.
Material and methods
Study group
The study was approved by the Ethics Committee of the
Medical Faculty of the University of Erlangen (162 12B)
and was organised in accordance with the Code of Ethics
of the World Medical Association (Declaration of Helsinki).
Informed consent was obtained from all participants.
From November 2011 until July 2014 a total of 36 con-
secutive patients (28 male and 8 female, mean (SD) age 51
(20) years) with unilateral fractures of the orbital floor that
met the criteria for mesh reconstruction according to the Ger-
man clinical guidelines in terms of size (large defects) and
configuration (insufficient support for resorbable alloplastic
reconstruction) of the defect in the orbital floor were included
in the study. Eighteen subjects each had a fracture of the
right orbital floor, and 18 a left-sided fracture. All patients
were operated on at the Department of Oral and Maxillofa-
cial Surgery at the University Hospital Erlangen, Germany. In
half the cases the injury resulted from sport-related trauma,
in a quarter from interpersonal violence, and in five from
road traffic accidents. Secondary procedures contributed to
four of the orbital floor reconstructions. All fracture patterns
were associated with an enlargement in orbital volume, a
displacement of bone fragments, or herniation of soft tissue.
Study design
All patients had physical examinations preoperatively, post-
operatively, and during follow-up after three and six months.
All operations were done by the same two surgeons, both
Please cite this article in press as: von Wilmowsky C, et al. Use of CAD-based pre-bent implants reduces theatre time in orbital floor
reconstruction: results of a prospective study. Br J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.bjoms.2019.11.020
specialists in oral and maxillofacial surgery with more than
six years of experience in orbital reconstruction.
Orbital floor plates are indicated in larger defects
(>2 cm2 ) with appreciable herniation of orbital tissues into
the maxillary sinus.2,3,8,9,10,12 Orbital floor mesh plates,
(MatrixMIDFACE Orbital Floor, Synthes), were individually
pre-bent in a CAD-based process, or non-preformed plates
were intraoperatively shaped. Patients received a bre-bent
titanium mesh if there was adequate time for fabrication,
and reconstruction with non-preformed meshes was done in
cases of time constraints. In total, 25 patients were treated
with individually pre-bent titanium meshes, and 11 had non-
preformed and intraoperatively shaped orbital floor plates and
acted as controls.
Fabrication of 3-dimensional models
A preoperative CT of the midface was taken (Fig. 1A). The
image data were transferred to the Mimics 14.1 and 3-matic
6.1 software (Materialise) and a virtual 3-dimensional model
was constructed (Fig. 1B). Every individual CT slice was
virtually segmented and manually corrected to compose the
reconstructed orbital floor. The reconstructed orbit was incor-
porated in a cubic frame (Fig. 1C) to create a sturdy physical
model as a bending template. The virtual model was con-
verted into stereolithographic format and transferred to the
3-dimensional printer (ZPrinter, 3D Systems, Rock Hill) for
creation of a 3-dimensional model.
Creation of customised orbital floor plates
The titanium mesh was customised in size and shape based on
the individual 3-dimensional template (Fig. 1D). The mesh
was further processed by smoothing, polishing, and sterilisa-
tion (Fig. 1E).
Reconstruction of the orbital floor
Intraoperatively, the duration of the actual insertion of the
implant was assessed. The recording started after the frac-
ture had been fully exposed and prepared for insertion of the
orbital mesh. Time recording was stopped when the mesh was
in the final shape and position without any need for additional
corrections (Fig. 1F).
Assessment of accuracy of fitting
The implant’s congruence to anatomical landmarks of the
orbital floor was evaluated intraoperatively. The inferior
orbital rim served as the anterior reference point and the
orbital process of the palatine bone was the posterior
reference.3 The same landmarks were analysed on postoper-
ative cone-beam CT scans.11 The congruence was calculated
by measuring the distance between the implant and the recon-
structed orbital floor. Congruence was graded as “complete”,
“good”, or “acceptable”.
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Fig. 1. (A) The coronal computed tomographic (CT) images show a left-sided fracture of the orbital floor with herniation of the orbital contents into the left
maxillary sinus. (B) A virtual 3-dimensional model was reconstructed based on the preoperative CT scan with the Mimics 14.1 and 3-matic 6.1 software
(Materialise) and served as the basis for virtual reconstruction of the orbit. (C) The orbital floor was reconstructed by virtual segmentation and correction of
individual CT slices. (D) The virtual model was converted into a 3-dimensional model and was incorporated in a cubic frame to create a sturdy physical model.
(E) The orbital plate was individualised in size and shape based on the reconstructed 3-dimensional model. (F) A left-sided orbital floor fracture was fully
exposed and the orbital mesh inserted in the proper position. * = p < 0.001.

The fitting was classified as “accurate” if the entire orbital
floor defect was covered and if only minor adjustments of
the mesh were required. Titanium meshes, which covered the
defect but needed to be shortened, were graded as “too large”.
The implant was graded as “too small” if the defect was not
fully covered. The surgeon judged whether the insertion of a
pre-bent titanium plate simplified the surgical reconstruction
itself compared with the intraoperative adaptation of non-
preformed orbital plates. The surgeon rated the use of pre-
bent plates as “simplified”, “normal”, and “more difficult”.
Statistical analysis
We used IBM SPSS Statistics software (version 24, IBM
Corp). The significance of differences was calculated using

Please cite this article in press as: von Wilmowsky C, et al. Use of CAD-based pre-bent implants reduces theatre time in orbital floor
reconstruction: results of a prospective study. Br J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.bjoms.2019.11.020
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Fig. 2. Duration of insertion of the implants: the mean (SD) duration of inser-
tion of individually pre-bent meshes was significantly shorter (5.5 (5.4) min)
than that taken for non-preformed orbital plates (11.1 (7.7) min). * = p < 0.01.
Fig. 3. Difficulty of reconstruction: the use of CAD-based pre-bent implants
was rated as “simplified “in 15, “normal “in eight, and “more difficult “in
two cases compared with non-preformed titanium implants.
the Mann–Whitney U test and Fisherś exact test, as appro-
priate. Probabilities of <0.05 were accepted as significant.
Results
The mean (SD) duration of insertion of individually pre-
bent meshes (n = 25) was 5.5 (5.4) min, while non-preformed
orbital plates (n = 11) required 11.1 (7.7) min to be placed
(Fig. 2). The difference was significant (p = 0.001).
The ease of orbital reconstruction using the pre-bent
implants was rated by the surgeon as simplified in 15, normal
in eight, and more difficult in two cases compared with non
pre-bent titanium implants (Fig. 3).
The congruence of the infraorbital rim with pre-bent
meshes was graded “complete” in 15, “good” in six, and
“acceptable” in four cases. The congruence of the infraorbital
rim with non-preformed meshes was judged as “complete”
in six, “good” in one, and “acceptable” in one (Fig. 4). There
was no difference between the two groups (p = 0.85).
Please cite this article in press as: von Wilmowsky C, et al. Use of CAD-based pre-bent implants reduces theatre time in orbital floor
reconstruction: results of a prospective study. Br J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.bjoms.2019.11.020
Fig. 4. Congruence to the infraorbital rim: the congruence of the pre-bent
titanium mesh to the infraorbital rim was “complete” in 15, “good” in six,
and “acceptable” in four cases. The congruence of non-preformed meshes
to the infraorbital rim was found to be “complete” in six, “good” in one, and
“acceptable” in one.
Fig. 5. Accuracy of fitting of the individually pre-bent titanium meshes: the
accuracy of pre-bent orbital plates was “accurate” in 17, “too large” in six,
and “too small” in two cases.
The fitting accuracy of the implant form of CAD-based
pre-bent titanium meshes was rated as “accurate” in 17, “too
large” in six, and “too small” in two cases (Fig. 5).
Discussion
Preoperative CAD of individual orbital implants has become
an important element of orbital reconstruction,1,12,15 and the
use of titanium meshes in CAD-based orbital surgery is well
established.1,3,12 In this prospective study we evaluated the
time benefit and fitting accuracy of CAD-based pre-bent tita-
nium orbital plates compared with non-preformed titanium
meshes in orbital floor reconstruction.
The duration of insertion of CAD-based orbital plates was
significantly reduced compared to non-preformed meshes.
Nowadays, it is possible to reconstruct fractures of the
orbital floor accurately with pre-bent and individualised tita-
nium meshes using a CAD workflow and stereolithographic
models.1,3,12
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The computer-aided design of orbital plates provides mul-
tiple benefits for the patient, the surgeon, and the hospital. The
shorter duration of insertion can lead to reduced exposure to
anaesthetics, decreased blood loss, and a reduced time of
wound exposure.3,18 The precision of individually pre-bent
titanium plates facilitates surgical insertion.23 The hospital
may benefit economically from a reduced time of insertion
by reduction in operating time, which might translate into an
increase in surgical numbers.
A disadvantage of CAD-based orbital reconstruction is
the increase in total treatment time considering the addi-
tional effort required to design and produce individualised
orbital plates. Overall, it took about two days for a customised
titanium mesh to be planned, shaped, and sterilised.
In most cases, the surgeon rated the use of customised
orbital implants as a simplification of orbital reconstruction.
The extreme accuracy of customised orbital plates might lead
to a reduced number of attempts at insertion during intraop-
erative adaptation that might translate into reduced soft tissue
injury and less morbidity.
We compared the congruence of the infraorbital rim with
CAD-based pre-bent orbital plates to that of non-preformed
titanium meshes and there was no significant difference in
the fitting accuracy of customised titanium meshes. The CAD
workflow facilitates the process of orbital floor reconstruction
by providing individual orbital plates.24 The use of computer-
aided planning and pre-bent titanium meshes can improve
the accuracy of surgical results.1,3,12 CAD-based techniques
help to reduce the complexity of reconstructive surgery and
may decrease morbidity by making orbital surgery safer and
faster.3,13,25
The surgeon rejected five pre-bent titanium meshes
because the area of the actual fracture exceeded the size
suggested by the radiographic findings. These cases were
excluded from the study. Although CT scans are accurate,
the actual reconstruction might vary slightly from the virtual
plan. CT scans present an excellent display of bony structures,
but have shortcomings in the visualisation of orbital soft tis-
sues that might influence the fit of an implant and might lead
to incongruities of the mesh with the anatomy of the individ-
ual orbit. Intraoperative modifications or even rejection of the
implant might therefore become necessary.1,2,12,23 Sufficient
support of the globe and its surrounding soft tissues cannot be
guaranteed if the size of an implant proves to be too small.3
One of the limitations of this study was its small sample
size, and there was also unequal distribution between the two
study groups. In conclusion, we have underlined the trend
towards CAD of orbital implants by highlighting its time
benefits and clinical advantages.
Conflict of interest
We have no conflicts of interest.
Please cite this article in press as: von Wilmowsky C, et al. Use of CAD-based pre-bent implants reduces theatre time in orbital floor
reconstruction: results of a prospective study. Br J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.bjoms.2019.11.020
5
Ethics statement/confirmation of patients’ permission
This study was approved by the Ethics Committee of the
Medical Faculty of the University of Erlangen (162 12B).
Written consent for publication was obtained from the patient
or guardian.
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Please cite this article in press as: von Wilmowsky C, et al. Use of CAD-based pre-bent implants reduces theatre time in orbital floor
reconstruction: results of a prospective study. Br J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.bjoms.2019.11.020