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Eur Arch Otorhinolaryngol

DOI 10.1007/s00405-017-4572-1

OTOLOGY

Modifications to a 3D-printed temporal bone model


for augmented stapes fixation surgery teaching
Yann Nguyen1,2 • Elisabeth Mamelle1,2 • Daniele De Seta1,2 • Olivier Sterkers1,2 •

Daniele Bernardeschi1,2 • Renato Torres1

Received: 30 January 2017 / Accepted: 17 April 2017


Ó Springer-Verlag Berlin Heidelberg 2017

Abstract Functional outcomes and complications in oto- perform the tasks and the forces applied to the incus during
sclerosis surgery are governed by the surgeon’s experience. crimping and placement of the prosthesis. However, sig-
Thus, teaching the procedure to residents to guide them nificantly lower forces were applied to the stapes by the
through the learning process as quickly as possible is senior surgeons in comparison with the junior surgeons
challenging. Artificial 3D-printed temporal bones are during prosthesis placement (junior vs senior group,
replacing cadaver specimens in many institutions to learn 328 ± 202.9 vs 80 ± 99.6 mN, p = 0.008) and during
mastoidectomy, but these are not suitable for middle ear prosthesis crimping (junior vs senior group, 565 ± 233 vs
surgery training. The goal of this work was to adapt such an 66 ± 48.6 mN, p = 0.02). We have described a new
artificial temporal bone to aid the teaching of otosclerosis teaching tool for otosclerosis surgery based on the modi-
surgery and to evaluate this tool. We have modified a fication of a 3D-printed temporal bone to implement force
commercially available 3D-printed temporal bone by sensors on the incus and stapes. This tool could be used as
replacing the incus and stapes of the model with in-house a training tool to help the residents to self-evaluate their
3D-printed ossicles. The incus could be attached to a 6-axis progress with recording of objective measurements.
force sensor. The stapes footplate was fenestrated and
attached to a 1-axis force sensor. Six junior surgeons Keywords Training  Educational  Stapedotomy  Middle
(residents) and seven senior surgeons (fellows or consul- ear  Piston  Prosthesis  Forces  Ossicular chain 
tants) were enrolled to perform piston prosthesis placement Otosclerosis
and crimping as performed during otosclerosis surgery.
The time required to perform the tasks and the forces
applied to the incus and stapes were collected and ana- Introduction
lyzed. No statistically significant differences were observed
between the junior and senior groups for time taken to Otosclerosis is an inflammatory bone disease leading to
bone dystrophy and involving the stapes footplate and the
bony labyrinth. It will result in stapes fixation and con-
Electronic supplementary material The online version of this ductive hearing loss at an early stage and inner ear lesions
article (doi:10.1007/s00405-017-4572-1) contains supplementary at a later stage giving mixed hearing loss.
material, which is available to authorized users.
Hearing rehabilitation can be performed either by
& Yann Nguyen hearing aids or surgical replacement of the stapes function.
yann.nguyen@inserm.fr Surgical treatment consists of resection of the stapes
1
superstructure, the fenestration or removal of the stapes
Sorbonne Universités, Université Pierre et Marie Curie Paris
footplate, and the placement and crimping of an ossicular
6, Inserm, UMR-S 1159 ‘‘Minimally Invasive Robot-based
Hearing Rehabilitation’’, Paris, France prosthesis between the incus and the fenestrated stapes to
2 restore the conductive properties of the middle ear. The
AP-HP, Groupe Hospitalier Pitié Salpêtrière, Otolaryngology
Department, Unit Otology, Auditory Implants and Skull Base procedure is very challenging and is performed through a
Surgery, Paris, France narrow field exposure with a speculum placed in the outer

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ear canal and involves millimetric and light fragile struc- Materials and methods
tures represented by the ossicular chain. When performed
by experienced surgeons, the technique yields excellent Population
results, with hearing improvement and a postoperative air-
bone gap of less than 10 dB in 90% of cases. Thirteen surgeons were enrolled in the study. All of them
The worst complication is sensorineural hearing loss were right-handed. The population was divided into two
which may be partial or total and irreversible. Functional groups depending on their otological experience. A junior
outcomes and occurrence of complications vary with the group was represented by six residents (two women and
surgeon’s experience [1, 2]. To improve the success rate four men) and a senior group was represented by six fel-
and diminish the incidence of complications among less lows and a consultant from our ENT department (three
experienced surgeons, technical modifications have pro- women and four men).
gressively been adopted in the last three decades. Stape-
dotomy instead of stapedectomy was proposed to lower Modification of the artificial temporal bone
sensorineural hearing loss [3]. Laser was used alone [4] or
in combination with a microdrill [5] to assist with footplate A commercially available 3D-printed temporal bone
fenestration and lower the risk of footplate fracture. Other (Schmidt model, left ear, Phacon, Leipzig, Germany) [14]
authors have proposed the use of robotic assistance to was modified to provide measurements of force applied to
increase safety during surgery [6]. Nevertheless, no tool or the incus and stapes. The malleus and stapes were removed
technique will be as valuable as the training, skills, and from the commercial device. An access point was drilled
experience of the surgeon to guarantee the success of the superiorly to expose the epitympanum and anteriorly to
surgery. expose the oval window from an inner ear perspective.
Most otologist have been trained through an These two access points allowed placement of a modified
apprenticeship in the operating room with the tradi- incus (Fig. 1a) and stapes (Fig. 1b) that were printed with a
tional adage ‘‘see one, do one, teach one’’, known as the stereolithographic technique. These two ossicle models
Halstedian method [7]. This clinical training can be were obtained from an ossicular chain segmentation
completed with a temporal bone dissection course or reported in a previous work [15]. Ablation of the super-
free practice in a temporal bone laboratory [8]. How- structures and a 500 lm fenestration were performed with
ever, access to cadaver specimens varies from one a microdrill to obtain a perforated footplate (Fig. 1b).
faculty to another and even more from one country to A Teflon tubing (length 3 mm, outer diameter 1 mm, inner
another. Changes in legislation on body donation [9], diameter 0.8 mm) was glued to the inner ear side of the
medical restrictions due to risk of prion diseases [10], footplate (Fig. 1d). This tubing could then be placed on the
and high costs have further reduced the access of res- contact ball of the 1-axis force sensor to ensure the con-
idents to temporal bone in many training programs. nection between the footplate model and a 1-axis force
Because of these restrictions, innovative teaching sensor (range 0–1 N, resolution: 10 mN, Millinewton force
methods such as artificial simulators using, for example, sensor, EPFL, Lausanne, Switzerland, http://lpm.epfl.ch/,
3D-printed temporal bones [11], animal models such as Fig. 2) and the incus was 3D printed connected to a rod to
sheep [12] or pig, or virtual simulators [13] are be mounted on a 6-axis force sensor (ATI Nano 17, cali-
employed to reduce the use of temporal bone specimens bration type SI-12-0.12, resolution: 3 mN, Apex, NC,
and shorten the learning curve. Three-dimensional USA, Figs. 1c, 3). Sensor data were recorded in real time
printed temporal bones offer a realistic anatomical via the same analog-to-digital interface card (NI 6210,
representation that can reproduce real-case anatomy National Instruments, Austin, TX, USA) and in-house
based on DICOM images acquired with a CT scan. software. Only components Dx, Dy, and Dz, provided by
Artificial bones are very beneficial in learning posterior the 6-axis force sensor, were averaged to obtain the norm
cavity drilling techniques but are less valuable in of the force applied to the incus.
teaching middle ear cleft surgery as the ossicular chain
is fixed and sometimes poorly reproduced. Experimental setup
In the present work, we describe how we have mod-
ified a commercially available 3D-printed artificial Participants were asked to place the prosthesis into the
temporal bone to provide objective measures for the fenestrated footplate and around the long process of the
learner to raise his interest in extended training for incus under microscopic view (Kaps, Asslar, Germany) in a
otosclerosis prostheses placement and crimping on such transcanal approach through a 5 mm diameter ear specu-
an artificial simulator. lum. An image of the simulated surgical exposure is

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Fig. 1 Modified incus and stapes. The incus (a) and stapes (b) were inner diameter 0.8 mm) was cut and glued to the inner ear side of the
modified so as to be attached to force sensors. The incus was printed footplate (d). This tubing could then be placed on the contact ball of
jointly with a rod to ease attachment to a 6-axis force sensor (c). A the 1-axis force sensor to ensure the connection between the footplate
stapes footplate was printed and then drilled with a 500 lm model and the 1-axis force sensor. The stapes could then be attached
fenestration. A Teflon tubing (length 3 mm, outer diameter 1 mm, to a 1-axis force sensor

Fig. 2 Internal view of the modified artificial temporal bone. A Fig. 3 External view of the modified artificial temporal bone. A
commercially available 3D-printed temporal bone (Schmidt model, commercially available 3D-printed temporal bone (Schmidt model,
left ear, Phacon, Leipzig, Germany) was modified to include left ear, Phacon, Leipzig, Germany) was modified to include
measurement of force applied to the incus and stapes. An access measurement of force applied to the incus and stapes. An access
point was drilled to the vestibule to expose the oval window niche point was drilled from the tegmen to the epitympanum and the incus
from the inner ear side. The stapes was removed from the commercial was removed from the commercial artificial temporal bone. It was
temporal bone and replaced by an in-house 3D-printed stapes. This replaced by an in-house incus 3D-printed jointly with a rod that could
stapes model was mounted on a 1-axis force sensor (Millinewton be attached to a 6-axis force sensor (ATI Nano 17, Apex, NC, USA).
force sensor, EPFL, Lausanne, Switzerland). This sensor allowed This sensor allowed measurement of force applied to the incus
measurement of force applied to the stapes
Tuttlingen, Germany) was used to place the piston into the
represented in Fig. 4. The prosthesis used was a titanium stapedotomy and around the incus, and a McGee wire
K-Piston with a 4.5 mm length and 0.4 mm shaft diameter crimping micro forceps (McGee wire crimper straight, ref
(Kurtz, Dusslingen, Germany). A Hartmann alligator micro 227400, Storz) was used to crimp the piston. The prosthesis
forceps (Hartmann ear forceps, ref 221150, Storz, placement and crimping were assessed by an external

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Duration of the procedure

No statistically significant differences were observed


between the two groups with regard to duration of the
procedure for prosthesis placement (junior vs senior group,
26 ± 13 vs 15 ± 4.5 s, p = 0.13) or for prosthesis
crimping (junior vs senior group, 28 ± 10.5 vs 20 ± 7.4 s,
p = 0.31).

Force applied to the incus

No statistically significant differences were observed


between the two groups with regard to forces applied to the
Fig. 4 Middle ear cleft exposure through the external auditory canal. incus during prosthesis placement (junior vs senior group,
The use of an artificial temporal bone (Schmidt model, left ear, 720 ± 203.4 vs 338 ± 233.1 mN, p = 0.07) or during
Phacon, Leipzig, Germany) allowed the surgical and anatomical prosthesis crimping (junior vs senior group, 433 ± 334.1
environment to be reproduced with high accuracy. The incus in this vs 182 ± 169.3 mN, p = 0.11).
model was replaced by an in-house 3D-printed incus to attach it to a
force sensor. This image shows the implementation of our incus
model into the commercial artificial temporal bone Force applied to the stapes

evaluator. After each trial, the prosthesis was removed, Statistically significant differences were observed between
visually inspected, and replaced by a new one if damaged. the two groups with regard to forces applied to the stapes
by the two groups. Lower forces were applied by the senior
Analysis surgeons in comparison with the junior surgeons during
prosthesis placement (junior vs senior group, 328 ± 202.9
Numbers of trials required to complete the procedure were vs 80 ± 99.6 mN, p = 0.008) and during prosthesis
collected. The procedure was considered completed when crimping (junior vs senior group, 565 ± 233 vs
the prosthesis could be placed and crimped in a single step. 66 ± 48.6 mN, p = 0.02).
Only the first completed procedure by the participant The results of duration and force measurements for
including prosthesis placement and crimping was analyzed. prosthesis placement and crimping are, respectively,
Time taken to complete these two steps was also collected. reported in Figs. 5 and 6.
Considering the force measurements, we investigated the
shape of the curve corresponding to the force versus time
during the two steps of the procedure. The peak force Discussion
applied to the incus and footplate during placement of the
prostheses on the long process of the incus was collected. This study describes a training model based on modified
We believed that it was reasonable to assume that this metric 3D temporal bone with measurement of force applied to the
would represent potential damage to the ossicular chain or incus and stapes during prosthesis placement and crimping
the cochlea if an excessive force was applied. Results were in simulated otosclerosis surgery. We have shown that,
expressed as mean ± standard deviation. Data were ana- during these steps in the surgical procedure, surgeons with
lyzed and graphics were generated with R version 3.1.3 (R otological experience would apply a gentler force to the
Core Team, 2013, R, Vienna, Austria). Data are presented as stapes in comparison to surgeons with short or no previous
mean ± standard deviation. We used the Mann–Whitney otological experience.
test to evaluate statistical significance for duration of the
procedure and force applied to the stapes and incus. p values Advantages and limits of this simulator
\0.05 indicated a statistically significant difference.
3D-printed temporal bones generally offer a high fidelity
for visual and anatomical representation. Thus, the
Results dimensions, approach, and exposure of the surgical field
could be easily reproduced in this simulator using
In the senior group, 3 ± 2.8 trials were required to achieve commercially available temporal bone. With the possi-
the first completed trial. In the novice group, 9 ± 9.7 trials bility to customize printed temporal bone, it would be
were necessary. easy to change the surgical scenario from a left to a right

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Fig. 5 Collected metrics for evaluation of prosthesis placement in an difference was observed between the groups for duration of the task
otosclerosis surgery model. Six junior surgeons (residents) and seven or force applied to the incus. The senior surgeons applied significantly
senior surgeons (fellows or consultants) were enrolled to perform a lower forces to the stapes in comparison with the junior surgeons
piston prosthesis placement in our modified temporal bone model. during prosthesis placement (junior vs senior group, 328 ± 202.9 vs
The duration of the task and forces collected via two force sensors and 80 ± 99.6 mN, p = 0.008)
applied to the incus and stapes were investigated. No significant

ear or simulate difficult cases for advanced surgeons sensor and this creates a leverage effect that does not
such as a narrow oval niche with facial nerve overhang directly reflect the effort applied to the incus. The exact
or necrosis of the long process of the incus. Furthermore, force applied to the incus could not be calculated from the
use of a physical simulator allows the learner to use real moment of the force as the angle of the applied force may
tools (microscope, surgical tools, and prosthesis) to vary constantly during prosthesis placement and crimping.
become accustomed to the tools available in the oper- The previous studies have already reported that expert sur-
ating room. Another advantage of such a simulator is its geons would apply less force during otosclerosis surgery
versatility to compare the user friendliness of different simulation compared to junior surgeons [16, 17]. Moreover,
techniques (e.g., different types of prosthesis, robot- some other critical steps in the otosclerosis surgery such as
based versus manual technique, etc.), although compli- scutum lowering or footplate fenestration were not simu-
ance of the ossicular chain does not reflect human lated. Difficult intraoperative conditions such as bleeding
physiology and no prediction on hearing outcomes can were not reproduced. In addition, intraoperative complica-
be estimated from a comparison of techniques or pros- tions such as incus fracture, incudo-malleolar joint rupture,
theses with our simulator. and floating footplate, could not be reproduced in this sim-
Nevertheless, some drawbacks limit the value of this ulator. Finally, the cost of the force sensors (around
simulator. Its realism for ossicular chain palpation has not 30–50 eu for the 1-axis force sensor and 10,000 eu for the
been objectively compared to a real ossicular chain. Fur- 6-axis force sensor) and the need for a computer may
thermore, absolute force measurement values cannot be hamper widespread academic use of this simulator, even
considered to compare them with the previous reports on though it can be reused without deterioration through time.
ossicular chain manipulation. Indeed, the incus in our setup This cost could be reduced with the use of a 3-axis force
is mounted on a long rod for attachment to the 6-axis force sensor (around 1000 eu) instead of a 6-axis force sensor.

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Fig. 6 Collected metrics for evaluation of prosthesis crimping in an difference was observed between the groups for duration of the task
otosclerosis surgery model. Six junior surgeons (residents) and seven or force applied to the incus. The senior surgeons applied significantly
senior surgeons (fellows or consultants) were enrolled to perform a lower forces to the stapes in comparison with the junior surgeons
piston prosthesis crimping in our modified temporal bone model. The during prosthesis crimping (junior vs senior group, 565 ± 233 vs
duration of the task and forces collected via two force sensors and 66 ± 48.6 mN, p = 0.02)
applied to the incus and stapes were investigated. No significant

Other models of otosclerosis training surgery efficient haptic devices with multiple degrees of freedom
and force feedback. Thus, a 3-axis force feedback haptic
The estimated learning curve for otosclerosis surgery is interface (three translations) cost around 1500–2000 eu and
between 60 and 80 cases [18] and complications can occur a 6-axis force feedback interface (three translations and
even after the first successful cases [19]. For these reasons, three translations) cost around 30,000 eu.
simulators have been designed to train residents. Some
authors have created simple artificial surgery boxes to per-
form training outside the operating room [20–22]. A more Conclusion
complex model reproducing not only otosclerosis but also
chronic otitis scenarios was proposed by Mills and Lee [23]. We report a new teaching tool for otosclerosis surgery
These simulators are low cost and easy to transport but have based on modification of 3D-printed temporal bone to
a limited representation of the anatomy of the middle ear implement force sensors on the incus and stapes and
ossicles. Thus, Murrant and Gatland proposed to glue the measure the forces applied to these ossicles. We have
oval window to reproduce pathological conditions observed observed that senior surgeons apply a lower peak force on
in otosclerosis in cadaver models [24]. Another totally dif- the stapes during prosthesis manipulation. The best use of
ferent approach is represented by a virtual simulator. This this simulator would be to use it as a training tool to help
has become very popular for temporal bone drilling teaching residents self-evaluate their progress with recording of
[13, 25] but less so for otosclerosis surgery training [26]. objective measurements. On one hand, this training would
With such simulations, residents could train without raise their confidence but also allow them to improve their
restrictions even with personal computers outside medical hand positioning, accuracy, and steadiness as reported in
faculties. The main drawback of virtual simulators is the other models of middle ear surgery training [27, 28]. The
poor haptic feedback that is limited by the prohibitive cost of next steps will be to modify the model to create additional

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surgical scenarios such incus necrosis, or a narrow oval stapedectomy training. Eur Arch Otorhinolaryngol
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Compliance with ethical standards ulator: a public PC application for GPU-accelerated haptic 3D
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Human and animal rights statement This article does not contain
14. Roosli C, Sim JH, Mockel H, Mokosch M, Probst R (2013) An
any studies with human participants or animals performed by any of
artificial temporal bone as a training tool for cochlear implanta-
the authors. This research received no specific grant from any funding
tion. Otol Neurotol 34(6):1048–1051
agency in the public, commercial, or not-for-profit sectors.
15. Kazmitcheff G, Miroir M, Nguyen Y, Ferrary E, Sterkers O,
Cotin S, Duriez C, Grayeli AB (2014) Validation method of a
Conflict of interest The authors indicate no potential conflict of
middle ear mechanical model to develop a surgical simulator.
interest. The authors would like to thank Armand Czaplinski for his
Audiol Neurootol 19(2):73–84
assistance with the drawing of the 3D models, the modified incus, and
16. Bergin M, Sheedy M, Ross P, Wylie G, Bird P (2014) Measuring
stapes used in this study.
the forces of middle ear surgery; evaluating a novel force-de-
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