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Accepted Manuscript

Predictability in orbital reconstruction: a human cadaver study. Part II: navigationassisted orbital reconstruction
Leander Dubois, Ruud Schreurs, Jesper Jansen, Thomas J.J. Maal, Harald Essig,
Peter J.J. Gooris, Alfred G. Becking
PII:

S1010-5182(15)00246-2

DOI:

10.1016/j.jcms.2015.07.020

Reference:

YJCMS 2143

To appear in:

Journal of Cranio-Maxillo-Facial Surgery

Received Date: 5 May 2015


Revised Date:

6 July 2015

Accepted Date: 21 July 2015

Please cite this article as: Dubois L, Schreurs R, Jansen J, Maal TJJ, Essig H, Gooris PJJ, Becking
AG, Predictability in orbital reconstruction: a human cadaver study. Part II: navigation-assisted orbital
reconstruction, Journal of Cranio-Maxillofacial Surgery (2015), doi: 10.1016/j.jcms.2015.07.020.
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to
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Predictability in orbital reconstruction: a human cadaver study. Part II:
navigation-assisted orbital reconstruction

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Leander Duboisa, Ruud Schreursb, Jesper Jansena, Thomas J.J. Maalb, Harald Essigc, Peter J.J. Goorisa,
Alfred G. Beckinga

of Oral and Maxillofacial Surgery, Orbital Unit, Academic Medical Centre of

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aDepartment

Amsterdam, University of Amsterdam, Academic Centre for Dentistry (ACTA), Meibergdreef 9,

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1105 AZ Amsterdam ZO, The Netherlands (Head: prof.dr. J. de Lange).

Laboratory Oral and Maxillofacial Surgery, University of Amsterdam, Meibergdreef 9, 1105

AZ, Amsterdam ZO, The Netherlands (Head: prof.dr. J. de Lange).


c

Department of Oral and Maxillofacial Surgery, University Hospital of Zrich, Frauenklinikstrasse 24,

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CH-8091 Zrich, Switzerland (Head: prof.dr. dr. M. Rcker).

Leander Dubois

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Send correspondence and reprint requests to:

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Department of Oral and Maxillofacial Surgery


Academic Medical Centre, Academic Centre for Dentistry Amsterdam, University of Amsterdam
Meibergdreef 9

1105 AZ Amsterdam ZO
The Netherlands
T: +31 20 5661364
F: +31 20 5669032

E-mail: L.Dubois@amc.uva.nl

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Funding: This study was supported by the KLS Martin Group (Tuttlingen, Germany) and BrainLAB AG
(Feldkirchen, Germany). All orbital implants for this study were donated and their stereolithographic
files provided by KLS Martin. The navigation equipment suitable for cadaver experiments was

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provided by BrainLAB AG. Neither organization had any involvement in the study design, collection
and interpretation of data, writing of the manuscript, and/or decision to submit the manuscript for

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publication.

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Predictability in orbital reconstruction: a human cadaver study. Part II: navigation-assisted orbital
reconstruction
SUMMARY

Preformed orbital reconstruction plates are useful for treating orbital defects. However, intraoperative

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errors can lead to misplaced implants and poor outcomes. Navigation-assisted surgery may help optimize
orbital reconstruction. We aimed to explore whether navigation-assisted surgery is more predictable than
traditional orbital reconstruction for optimal implant placement. Pre-injury computed tomography scans

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were obtained for 10 cadaver heads (20 orbits). Complex orbital fractures (Class IIIIV) were created in all
orbits, which were reconstructed using a transconjunctival approach with and without navigation. The best

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possible fit of the stereolithographic file of a preformed orbital mesh plate was used as the optimal position
for reconstruction. The accuracy of the implant positions was evaluated using iPlan software. The
consistency of orbital reconstruction was lower in the traditional reconstructions than in the navigation
group in the parameters of translation and rotation. Implant position also differed significantly in the

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parameters of translation (p = 0.002) and rotation (pitch: p = 0.77; yaw: p <0.001; roll: p = 0.001). Compared
with traditional orbital reconstruction, navigation-assisted reconstruction provides more predictable

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anatomical reconstruction of complex orbital defects and significantly improves orbital implant position.

Keywords: navigation; orbital fractures; orbital implants; reconstructive surgical procedures; surgery,

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computer-assisted; treatment outcome

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INTRODUCTION

The orbit is often affected by traumatic injuries, which can result in aesthetic deficits and functional ocular
impairment, especially when the reconstruction is suboptimal (Wilde and Schramm, 2014). Precise
reconstruction of the orbit is the primary step in restoring normal function and aesthetics of the orbit;

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however, it is difficult to accomplish (Dubois et al., 2015a). The complexity of orbital reconstruction in posttraumatic and post-ablative defects is well described in the published literature (Hammer, 1995, Burnstine,
2002, Gellrich et al., 2002, Ewers et al., 2005, Schramm et al., 2009, Rana et al., 2012, Essig et al., 2013b,

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Dubois et al., 2015a, b, and c).

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Reconstruction outcome is unpredictable because of the difficulty of optimally reconstructing the complex
orbital contour (Ellis and Tan, 2003, Markiewicz et al., 2012, Dubois et al., 2015c). Anatomical orbital
landmarks function as important surgical guides and may be helpful during reconstruction of the orbit.
However, it may be difficult to locate the posterior ledge, which is the most important dorsal anatomical
landmark and provides essential support for reconstruction material (Manson et al., 1986, Hammer, 1995,

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Kakibuchi et al., 2004). This is especially the case in a traumatized orbit with the combination of a
comminuted fracture of the thin orbital floor and disrupted orbital soft tissue.

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Limited surgical exposure hinders the view of the orbital defect and the verification of implant position
during surgery (Markiewicz et al., 2012), which may be an important reason for suboptimal placement of

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the implant and for unsatisfactory outcomes such as enophthalmos and/or diplopia. Manson et al. (1986)
were the first to associate improper implant positioning with inadequate restoration of orbital volume,
resulting in enophthalmos.

Recently, preoperative computer-assisted planning with virtual implant placement has been combined with
intraoperative navigation in an attempt to reconstruct the bony orbit more accurately and optimize
treatment outcome. The first step in computer-assisted surgery for orbital reconstruction is segmenting the
orbital walls and orbital volume. By using a mirroring technique (Bruneau et al., 2013, Essig et al., 2013b),
the unaffected side can be copied to the deformed side, creating a template for a custom-made ideal orbit.

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The outcome of the surgical correction depends on the shape and positioning of the orbital implants
(Metzger et al., 2007, Rana et al., 2012, Essig et al., 2013b). One advantage of using a preformed implant is
that a stereolithographic (STL) software file of the implant can be used preoperatively to find the optimal fit
and position in a digital environment (Fig. 1). However, an optimally formed implant does not automatically

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result in optimal implant placement (Fig. 2).

A computer model can be used intraoperatively as a virtual template to navigate the preplanned bony
contours and assess implant fit. Intraoperative navigation assists the surgeon in optimal reconstruction

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(Gellrich et al., 2002, Schmelzeisen et al., 2004, Bell and Markiewicz, 2009, Yu et al., 2010, Andrews et al.,
2013, Yu et al., 2013). Wilde et al. (2014) suggested that computer-assisted surgery helps achieve

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predictable outcomes in reconstruction. In the largest clinical cohort study published to date (n = 104), Yu
et al. (2013) demonstrated that navigation-assisted surgery (NAS) provided promising and accurate results
for the treatment of midfacial deformities. As described by Zhang et al. (2012), NAS probably increases
predictability and could become an essential part of the workflow for complex orbital reconstructions.

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Markewietz et al. (2012) concurred with the authors of previous reports and concluded that future studies
should explore whether NAS is preferable to conventional techniques for true-to-origin orbital
reconstruction.

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The aim of this study was to assess the predictability of navigation-assisted orbital reconstruction for

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implant positioning in complex defects in a human cadaver model (Class IIIIV) (Dubois et al., 2015c).

MATERIALS AND METHODS

Materials

The human specimens used for this study had been previously used for a study of endoscopic-assisted
orbital reconstruction (Dubois et al., unpublished results). Ten human cadaver heads were obtained from
the Department of Anatomy of the Academic Medical Centre of the University of Amsterdam. One orbit was
excluded because of sinus pathology (osteoma), resulting in a total of 19 orbits eligible for this study.

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The orbital floor and medial wall were fully exposed through a standard transconjunctival incision and
retroseptal preparation. Following the Jaquiry classification (Jaquiry et al., 2007, Kunz et al., 2013),
complex orbital defects (Class IIIIV) were created with piezoelectric surgery (Mectron, Carasco, Italy)
Computed tomographic scans of the cadaver heads were performed at baseline (with intact orbits, T0), after

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creation of the orbital defects (T1), and postoperatively after implant placement (T2) (Sensation 64,
Siemens Medical Solutions, Forchheim, Germany). Scan parameters included collimation of 20 0.6 mm,
120 kV, 350 mAs, pitch 0.85, FOV 30 cm, matrix 512 512, reconstruction slice thickness of 0.75 mm with

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overlapping increments of 0.4 mm, bone kernel H70s, and bone window W1600 L400.

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Validation study

The poor consistency of traditional orbital reconstruction, as has been described in an endoscope study
(Dubois et al., unpublished results), is shown in Table 1. A validation study was performed to investigate the
consistency of navigation-assisted orbital reconstruction. Two oral and maxillofacial surgeons (LD and PS),
experienced in the field of orbital reconstruction, performed 10 orbital reconstructions on the cadaver

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heads using preformed orbital titanium mesh plates (KLS Martin, Tuttlingen, Germany) and a navigationassisted workflow (Curve, BrainLAB AG, Feldkirchen, Germany).

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Methods

In the first surgical session, all 19 orbits were reconstructed with a transconjunctival approach (traditional

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group) by both surgeons (LD, PG). In a second session, the orbits were reconstructed with a
transconjunctival approach combined with navigation by the same surgeons. The implant was placed in the
correct position according to the navigation outcomes. The implants were fixed with one bone screw. The
drill holes were covered and camouflaged between the two sessions by filling with DuraLay (Reliance
Dental Mfg. Co., Worth, Illinois, USA). For consistency of measurement, one surgeon (LD) performed the
reconstructions twice for both groups. After each reconstruction, the surgeon filled out a questionnaire
regarding the perceived predictability and quality of reconstruction. These methods were similar to those

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used by the same research group in a previous study on endoscopic-assisted orbital reconstruction (Dubois
et al., unpublished results).

Contour analysis

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The quality of the reconstruction was evaluated using iPlan software (version 3.05, BrainLAB AG,
Feldkirchen, Germany). The optimal implant position was determined by information from the T0 and T1
scans with two surgeons (LD, PG) in agreement. In both the traditional and navigation groups, the

postoperative (T2) scan was superimposed on the T0 scan with the image fusion modality, available in the

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iPlan software. A threshold segmentation with a threshold of 1200 Hounsfield units was performed to

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segment the resulting implant in the T2 scan. The osteosynthesis screw and excess bony tissue were
removed from the segmentation result because these structures were not present in the STL model of the
planned implant. The three proximal osteosynthesis rings were excluded because their position could have
been altered during the surgery by bending. An STL model of the planned implant and the segmentation of
the resulting implant were exported from the iPlan software. The orbital implant dislocation frame (OIDF),

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described in a previous study (Schreurs et al., unpublished results) was used to quantify rotational
differences (roll, pitch, and yaw) and translational differences between the STL models of the planned
implant and the final implant (Fig. 3). Translational differences were expressed as total displacement, which

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Statistical analysis

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resulted in the Euclidean distances of the translation given in the x, y and z directions.

To assess inter- and intraobserver variability between the reconstructions, the interclass correlation
coefficient (ICC) was calculated for the pitch, yaw, roll, and translation for the reconstructions in the
validation study. A paired t test was used to compare the translation and rotation (pitch, yaw, and roll) of
the preformed orbital plate in relation to the planned ideal implant position between the traditional and
navigation groups. Statistical data analysis was performed using SPSS software (IOS X, version 22.0; SPSS,
Inc., Chicago, IL, USA). P <0.05 was considered statistically significant.

RESULTS

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Validation study

The consistency of the orbital implant position in terms of translation (ICC 0.76, 95% confidence interval
[CI] 0.250.94) and rotation (pitch: ICC 0.78, 95% CI 0.300.95; yaw: ICC 0.87, 95% CI 0.530.97; roll: ICC

lower in the traditional group than in the navigation group (Table 1).

Comparison of traditional and navigation groups

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0.51, 95% CI 0.180.86) was high in the navigation group. The consistency in orbital reconstruction was

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On the CT images, none of the orbital implants were positioned below the ledge in the traditional or
navigation groups.

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Full-defect contours were exposed in 47.4% of the reconstructions in the traditional group. However, defect
boundaries were visualised by navigation in 100% of the reconstructions in the navigation group. The
surgeons satisfaction rate was lower in the traditional group than in the navigation group (Wilcoxon signed

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rank test, p <0.001), which was in accordance with the actual postoperative results.

The difference between the two groups in implant position (translation, yaw, and roll) was statistically
significant, with the navigation group showing more favourable results (paired t test, p <0.05; Table 2).

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Even in cases of navigation-assisted orbital reconstruction, medial wall involvement resulted in significantly
higher yaw than reconstructions in orbits with intact medial walls (independent sample t test, p = 0.008).

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However, medial wall involvement was not associated with significant differences in translation, pitch, or
roll (Table 3). More complex defects (Class III vs. IV) were not associated with a higher degree of implant
dislocation (independent sample t test, p >0.05; Table 4).

Plots of the implant positions and the most frequent translations and rotations are shown in Fig. 4 and 5.
The 95% confidence interval has been marked for both groups.

DISCUSSION

Advanced diagnostic techniques, such as mirroring the unaffected orbit to set anatomical boundaries and

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fitting a preformed or patient-specific implant in a digital environment, have proven to be viable tools for
true-to-origin orbital reconstruction (Gellrich et al., 2002, Schmelzeisen et al., 2004, Markiewicz et al., 2011
and 2012, Cai et al., 2012, Rana et al., 2012, Essig et al., 2013b). With preoperative planning, the surgeon is
able to set a clear target for ideal implant position. However, the relationship between the final position

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and the planned position must be verified intraoperatively. Navigation-assisted surgery provides the
surgeon with an intraoperative tool for orientation and comparison of the actual implant location with the
target location, presumably preventing improper implant placement.

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Several reports have described the use of intraoperative navigation for orbital reconstruction of posttraumatic defects (Gellrich et al., 2002, Schmelzeisen et al., 2004, Bell and Markiewicz, 2009, Yu et al., 2010,

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Zhang et al., 2012, Rana et al., 2012, Yu et al., 2013, Gander et al., 2015). Some of these studies showed
that navigation-assisted orbital reconstruction is effective in restoring orbital volume and globe dimensions
in complex defects (Gellrich et al., 2002, Markiewicz et al., 2011 and 2012, Zhang et al., 2012, Rana et al.,
2012). However, none of these studies compared the effects of orbital reconstruction with and without the

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use of intraoperative navigation. The authors believe that this is the first study to directly compare the
effect of navigation on orbital reconstructive surgery within the same specimen.

This study clearly indicates that NAS is a reliable tool that enables significantly better and more consistent

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orbital implant placement. It may also reduce the risk of improper placement for experienced orbital

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surgeons who have no experience with navigation (PG). A common cause of inaccurate implant placement
is the inability to define the posterior orbital ledge (Manson et al., 1986, Kakibuchi et al., 2004). In our
study, none of the implants were positioned below the ledge, even in the traditional group. This study
demonstrates that when navigation is not used, suboptimal implant placements by experienced surgeons
are most frequently caused by translation in the x-axis, in combination with yaw (Fig. 4 and 5). Navigationaided surgery significantly reduces these translation and rotation errors. Perfect placement was defined as
the difference between the planned position and the actual position within a calibration error of 12 mm
(Metzger et al., 2007, Zhang et al., 2012, Essig et al., 2013a), which corresponds to a deviation of less than 1
mm per axis and a yaw of less than 8. Although navigation enables significantly better placement than

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other techniques while retaining a similar level of precision (Markiewicz et al., 2011 and 2012, Cai et al.,
2012, Essig et al., 2013b), it is still not perfect. More predictable true-to-origin reconstructions may be
possible with further development of the technology. Given the current dissimilarities, our group promotes
intraoperative imaging as an additional tool to check the orbital implant position.

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Although NAS can be used for all orbital reconstructions, previous studies have suggested that it is primarily
beneficial for complex defects (Gellrich et al., 2002, Markiewicz et al., 2012, Essig et al., 2013b). Complex
defects include those with medial wall involvement, loss of the transition zone, or orbital defects extending

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to the posterior third of the orbital floor. Through the combination of medial and inferior-posterior orbital
fat bulging, it may often be difficult to place the implant in the optimal position. In this study, NAS

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significantly reduced improper implant placements in these complex defects, as compared with
conventional implant placement performed without the aid of computer-assisted navigation.

This study was performed with cadavers to directly compare the quality of orbital reconstruction with and
without intraoperative navigation. In our opinion, a cadaver study has many advantages for verifying the

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quality of treatment options. Treating the same fracture twice under comparable circumstances makes it
possible to compare both methods on the same cadaver and to evaluate intra- and intersurgeon variability.
The laboratory setting is also free of the stress and distraction of a clinical situation, where time constraints,

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psychological stress, and fatigue may come into play. However, cadaver tissues are of a different consistency

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than those of living patients, and in a cadaver model important clinical problems such as enophthalmos and
diplopia are not displayed. Because this study focused on lost anatomical boundaries and optimal
reconstruction, the texture of the human cadaver specimen was acceptable. Peri-orbital tissues are difficult
to assess in cadavers because of the firmer consistency of the orbital fat, but the main focus of this study
was reconstruction of the bones, which is of fundamental importance.

Most studies use orbital volume and reduction of volume as tools to describe the effect of the
reconstruction (Andrades et al., 2009, Markiewicz et al., 2011 and 2012, Strong et al., 2013b, Novelli et al.,
2014). As described by Strong et al. (2013a), orbital volume is an important predictor of enophthalmos.
However, critically assessing the actual implant position is also an important factor. As shown by Schreurs

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et al. (2015), even a malpositioned orbital implant can lead to a significant reduction of orbital volume and
a good clinical outcome, although it is not the desired result (Fig. 6).

By using the OIDF, the actual result can be instantly compared with the desired result, and the differences
between planned and actual results may be quantified for all rotational and translational parameters

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(Schreurs et al., 2015). In NAS, an important surgical goal is created in the preoperative planning phase; NAS
is regarded as target surgery. The additional value of navigation assistance in orbital reconstructive surgery
can therefore be quantified only if the surgical outcome is compared with the surgical target. Comparing the

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location of the final implant with that of the planned implant makes it possible to compare accuracy and
predictability between traditional and navigation-assisted reconstructions (Schreurs et al., 2015). In our

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study, additional analysis with the OIDF enabled comparisons of a higher level than simply making the
conclusion that navigation assistance improved implant placement. The rotational and translational
parameters also provided details on how the implant positioning was improved.

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CONCLUSION

Although several previous studies have reported promising results, this human cadaver study clearly proves
that for true-to-origin orbital reconstructions, the results of navigation-assisted reconstruction are more

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ACKNOWLEDGEMENTS

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consistent and predictable than those of traditional reconstruction techniques.

We thank Nick H.J. Lob and Ludo Beenen, from the Department of Radiology, and Eric J. Lichtenberg and
Petra E.M.H. Habets, from the Department of Anatomy, Embryology and Physiology, for their assistance in
logistics and cadaveric scanning. We also thank Irene H. A. Aartman for her advice on statistical analysis.

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Ophthal Plast Reconstr Surg. 29(1):1 5, 2013a. doi:10.1097/IOP.0b013e31826a24ea.

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doi:10.1016/j.joms.2009.07.058.

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Yu H, Shen SG, Wang X, Zhang L, Zhang S: The indication and application of computer-assisted
navigation in oral and maxillofacial surgery-Shanghais experience based on 104 cases. J
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TABLES
Table 1 Interclass correlation coefficients (ICC) for inter- and intra-surgeon variability.
Table 2 Evaluation of planned vs. realized orbital implant position by using the orbital implant
dislocation frame.
*Significant values, p <0.05.

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Table 3 Effect of medial wall involvement on planned vs. realized orbital implant position by using the
orbital implant dislocation frame (navigation group).
*
Significant values p <0.05.

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Table 4 Effect of complexity of the defect on planned vs. realized orbital implant position by using the
orbital implant dislocation frame (navigation group).
*
Significant value, p <0.05.

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FIG. LEGENDS
Fig. 1 BrainLab planning: ideal implant fit: a) three-dimensional view; b) coronal view, anterior part; c) coronal
view, posterior part; d) sagittal view.

Fig. 3. Degrees of freedom in translation and rotation.

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Fig. 2 Discrepancies in implant positions based on the three-dimensional reconstruction of pre- and
postoperative computed tomography images: a) coronal view, anterior part; b) coronal view, posterior part; c)
sagittal view; d) three-dimensional view.

Fig. 4 a) Cranial view, orbital implant; b) plot in cranial view of the navigation group; 95% confidence
interval, conventional group (dotted line), navigation group (straight line).

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Fig. 5 a) Frontal view, orbital implant; b) plot in frontal view of the navigation group; 95% confidence
interval, conventional group (dotted line), navigation group (straight line).

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Fig. 6 Example of misplaced implant, with a volume decrease of 4 cm3 and poor implant positioning.

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Table 1 Interclass correlation coefficients (ICC) for inter- and intra-surgeon variability
Conventional

.691

.322

.760

.665

95% CI[.106-.921]

95% CI [-.348-.774]

95% CI[.246-.940]]

95% CI[.314-.856]

.254

.067

.783

95% CI[-.451-763]

95% CI[-.557-.643]

95% CI[.300-.947]

95% CI[.330-.861]

.533

.385

.871

.301

95% CI[-.150-.871]

95% CI[-.283-.801]

95% CI[.533-.969]

95% CI[-.165-.657]

.742

.599

.512

.283

95% CI[.208-.935]

95% CI[-.005-.883]

95% CI[-.177-864)

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Table 2 Evaluation of planned vs. realized orbital implant position by using the OIDF.
*
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Navigation

Paired t test

Mean

SD

Mean

SD

Translation

4.98mm

2.19mm

3.29mm

1.64mm

Pitch

-1.29

3.05

-1.13

2.15

Yaw

17.81

10.91

8.82

8.05

Roll

-9.81

9.09

-2.3

4.79

Translation

4.90mm

1.35mm

Pitch

0.43

6.26

Yaw

21.99

Roll

-11.91

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(PG)

3.60

18

0.002*

-0.30

18

0.77

4.51

18

<0.001*

-3.81

18

0.001*

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(LD)

df

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1.35mm

2.27

0.05*

-2.10

3.46

1.58

0.15

13.17

7.94

10.5

2.28

0.05*

6.13

-9.60

5.13

-1.56

0.15

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Table 3 Effect of medial wall involvement on planned vs. realized orbital implant position by using
the orbital implant dislocation frame (navigation group).
Significant values p <0.05.

Translation

No medial
wall fracture
Mean
SD
3.24
1.86

Medial wall
fracture
Mean
SD
3.32
1.51

p
0.91

Pitch
Yaw
Roll

-0.57
3.97
-4.12

-1.63
13.19
-.68

0.30
0.008*
0.17

1.63
6.95
3.75

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2.60
6.40
5.37

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Table 4 Effect of complexity of the defect on planned vs. realized orbital implant position by using
the orbital implant dislocation frame (navigation group).
Significant value, p <0.05.

Translation

Class III
Mean
SD
3.15
1.69

Class IV
Mean
SD
3.47
1.64

p
0.68

Pitch
Yaw
Roll

-1.54
10.71
-2.06

-0.57
6.25
-2.65

0.35
0.24
0.80

2.2
10.24
4.45

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2.12
5.81
5.22

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