Accepted Manuscript

Clinical Analysis of MatrixMANDIBLE Preformed Reconstruction Plate Design

Fabian Duttenhoefer, MD, DDS, resident, Florian Andreas Probst, MD, DDS,
resident, Kirstin Vach, Dipl.-Math., statistician, Carl-Peter Cornelius, MD, DDS, senior
physician, Martin Zens, MD Dr.-Ing, Dipl.-Wi.-Ing, resident, Rainer Schmelzeisen, MD,
DDS, Marc Christian Metzger, MD, DDS, assistant medical director

PII: S1010-5182(17)30188-9
DOI: 10.1016/j.jcms.2017.05.022
Reference: YJCMS 2685

To appear in: Journal of Cranio-Maxillo-Facial Surgery

Received Date: 30 December 2016

Revised Date: 4 May 2017
Accepted Date: 29 May 2017

Please cite this article as: Duttenhoefer F, Probst FA, Vach K, Cornelius C-P, Zens M, Schmelzeisen R,
Metzger MC, Clinical Analysis of MatrixMANDIBLE Preformed Reconstruction Plate Design, Journal of
Cranio-Maxillofacial Surgery (2017), doi: 10.1016/j.jcms.2017.05.022.

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Clinical Analysis of MatrixMANDIBLE Preformed Reconstruction Plate Design

Fabian Duttenhoefer MD, DDSa, resident

Florian Andreas Probst MD, DDSb, resident

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Kirstin Vach Dipl.-Math.c, statistician
Carl-Peter Cornelius MD, DDSb, senior physician
Martin Zens MD Dr.-Ing., Dipl.-Wi.-Ing.a, resident

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Rainer Schmelzeisen MD, DDSa
Marc Christian Metzger MD, DDSa, assistant medical director

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Department of Oral and Maxillofacial Surgery, University Hospital, Freiburg, Germany

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Department of Oral and Maxillofacial Surgery, Ludwig-Maximilians University, Munich,
Germany
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Institute for Medical Biometry and Statistics, Faculty of Medicine and Medical Center,
Albert-Ludwig University, Freiburg, Germany
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Send correspondence and offprints to: Fabian Duttenhoefer

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Universitätsklinik für Zahn-, Mund- und Kieferheilkunde

Abteilung Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie

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Hugstetter Str. 55, D-79106 Freiburg, Germany

Phone: +49-761-270-49330, Fax: +49-761-270-4800

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e-mail: fabian.duttenhoefer@uniklinik-freiburg.de
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Running title: Clinical Analysis of MatrixMANDIBLE Design

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Introduction
The MatrixMANDIBLE Preformed Reconstruction Plates (MMPRPs) were developed
to overcome the laborious bending procedures of conventional reconstruction plates.
Besides reducing operating time, the biomechanical stress on the plate, known to
promote fatigue fracturing, could be avoided. Furthermore, morphometric shape
analysis of the anterolateral mandible in various ethnic populations resulted in a

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preshaped, load-bearing, osteosynthesis system designed to address the typical
complications of reconstruction plates, such as screw and plate loosening, and

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exposure of the plate with subsequent intra-oral or orocutaneous fistula formation
(Gellrich et al., 2004; Klotch et al., 1999; Martola et al., 2007; Metzger et al., 2011).

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Although plate design and materials have advanced significantly over recent
decades, rates of the complications mentioned above could not be reduced
substantially. To date, adequate soft tissue coverage is still of paramount importance

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for successful long-term rehabilitation (Klotch et al., 1999). A previous study,
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conducted in Germany by two oral and maxillofacial surgery centers, concluded that
MMPRPs present a feasible alternative to standard reconstruction plates that can
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successfully reduce surgery time and minimize the risk of fatigue fractures (Probst et
al., 2012). In this study, using postoperative radiographs, we assessed the necessary
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length of the bendable proximal and distal sections of MMPRPs, in a patient

collective that underwent mandibular reconstruction, by analyzing the most proximally
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or distally utilized screw holes. Statistical analysis comprises a comparison of the

three different plate dimensions (small, medium, large), age, and location of the
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implanted MMPRP.
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Patients and Methods
In our retrospective study, routinely conducted postoperative radiographs from a total
of 130 patients (24–95 years old, average age 63 years) who had received treatment
with MMPRP from March 2009 to October 2014 were assessed. All patients
underwent mandibular stabilization either in the oral and maxillofacial surgery
department at the University Medical Centre Munich, Germany or the University

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Medical Centre Freiburg, Germany, according to the manufacturer’s protocol
(Synthes, Inc., West Chester, PA, USA). Surgery was conducted upon each patient’s

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informed consent. The study protocol was approved by the institutional ethics
committee.

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MMPRPs are designed with a non-bendable and contiguous preformed centerpiece
that corresponds to the lateral body and angle division of the mandible, and two
bendable sections located at the proximal and distal ends. Three sizes are

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commercially available (small, medium, and large). The surgical protocol comprised
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surgical exposure of the fracture or resection site and, in trauma cases, anatomical
reduction of the fragments. To select the correct plate dimension (small, medium, or
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large) rigid metal spacers corresponding to the different plate dimensions were
inserted. After the correct size was determined, malleable aluminum templates were
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used to transfer the required overall shape, length, and curvature to the bendable
plate ends. Unnecessary parts were trimmed after the last used screw hole. The
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adjusted plates were then locked into position using adequate locking screws
(diameters 2.4 mm or 2.9 mm). To determine adequate reconstruction or fracture
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reduction of the mandible, postoperative radiographs were routinely conducted

(Figure 1). Available screw holes at the ramus and parasymphysis of the different-
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sized MMPRPs were numbered consecutively, starting from 1 at the center part of
the ramus or parasymphysis and ending with the terminal available screw hole.
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Screw holes available in the body section of the MMPRPs were numbered
consecutively, starting from 1 at the anterior part of the MMPRP next to the
parasymphysis and ending with the terminal available screw hole at the posterior part
next to the ramus of the MMPRP (Figure 2).
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Results
In this study a total of 130 patients (24–95 years old, average age 63 years) who had
received treatment with MMPRP from March 2009 to October 2014 were included.
The distribution of the three commercially available sizes of MMPRP was: 47 patients
received a small, 61 patients a medium, and 22 patients a large. There was no
statistical correlation between the size and the location (left/right) of the inserted
reconstruction plate, and the age of the patient.

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The ramus design of the MMPRP has a maximum of five available screw holes for
the small type of plate, and six screw holes for the medium and large types. Of the 47

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patients receiving a small MMPRP, 39 cases were treated without employing the
terminal screw hole of the ramus for plate fixation. In the statistical analysis

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confidence intervals for proportions were computed for analysis of numbers of
operations not using the terminal screw hole. The statistic revealed that 82.98% (95

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% confidence interval: 69.2–92.4) of the implanted small MMPRPs were trimmed by
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at least the terminal screw hole of the ramus part of the plate. Regarding the medium
plate in 56 of the 61 treated patients (91.80% CI: 81.9–97.3) the MMPRPs were
inserted without employing the terminal screw hole of the ramus. Of the 22 patients
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receiving a large MMPRP, none was inserted using the terminal screw hole of the
ramus, showing that all of the inserted large MMPRPs were trimmed by at least the
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terminal screw hole of the ramus part of the plate. The median of the employed
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consecutively numbered screw holes of the ramus was 4 in all three MMPRP sizes
(Figures 3a and 4a).
The design of the parasymphysis comprises a maximum of 10 screw holes for all
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types (small, medium, and large) of MMPRP. Statistical analysis showed that 87.23%
(95% CI: 74.3–95.2) of the implanted small MMPRPs, 88.52% (95% CI: 77.8–95.3) of
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the implanted medium size MMPRPs, and 81.82% (95% CI: 59.7–94.8) of the
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implanted large size MMPRPs were trimmed by at least the terminal screw hole of
the parasymphysis part of the plate. The median of the employed consecutively
numbered screw holes of the parasymphysis was 5 in all three MMPRP sizes
(Figures 3b and 4b).
The body design of the MMPRP comprises a maximum of seven screw holes for the
small and medium type of plate, and eight screw holes for the large type. Statistical
analysis of the screw hole assignment revealed that the median of the utilized and
consecutively numbered screw holes of the body was 3.7 in all MMPRP sizes (Figure
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5). In all three sizes there was no significant evidence that, in large defects or other
surgical conditions when no screw was inserted in the body, further terminal screws
were applied in either the parasymphysis or the ramus (Figure 6).

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Discussion
The load-bearing osteosynthesis system MatrixMANDIBLE Preformed
Reconstruction Plates (MMPRPs) has been developed using 3-D mandible shape
analysis based on more than 2000 CT-scans of Caucasian and Asian ethnic
populations. The shape and size of the MMPRPs were clustered by ramus length into
three sizes (small, medium, large) to fit a majority of patient mandibles (Metzger et

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al., 2011) and implemented successfully, in the daily clinical routine, in trauma and
reconstructive surgery, such as temporary or final defect bridging, and stabilization in

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complex or comminuted fractures of the mandible (Probst et al., 2012). Because of
less intra-operative plate bending and thus overinstrumentation, several studies could

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corroborate the increased resistance to fatigue fractures of MMPRPs when compared
with standard locking reconstruction plates, with fatigue fracture rates ranging from
2.8% to 9.8% (Lavertu et al., 1994; Gellrich et al., 2004; Katakura et al., 2004;

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Schupp et al., 2007). The rate of plate exposure, often associated with orocutaneous
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fistulas, is the most common complication of reconstruction plates. Metzger et al.
showed that MMPRPs exhibited similar exposure rates, with 16% of all cases when
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compared with comparable investigations ranging from 4% to 39% (Gellrich et al.,

2004; Klotch et al., 1999; Lopez et al., 2004; Alonso del Hoyo et al., 1994; R. E.
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Nicholson et al., 1997; Arden et al., 1999). Although, the initial fitting accuracy of the
MMPRPs has been shown to be up to 98.6%, and intra-operative bending time of the
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MMPRPs is reduced (Probst et al., 2012; Lethaus et al., 2012), plate handling still
requires bending and often cutting of the end portions.
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Our investigation assessed, in postoperative radiographs, the necessary length of the

bendable proximal and distal sections of MMPRP in a patient collective that
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underwent mandibular reconstruction by analyzing the most proximal or distal utilized

screw holes. Statistical analysis compared the three different plate dimensions
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(small, medium, large), patient age, and location of the implanted MMPRP. Previous
investigations indicated that the bony parts of the mandibular undergo significant
changes during senescence, such as mandibular angle as well as ramus and body
height (Shaw et al., 2010; Nicholson and Harvati, 2006) Interestingly, in our statistical
analysis there was no correlation between age and gender and the application of
plate size or utilized screw hole. Our results show that the majority of the bridged
defects or anatomical conditions where no screws were necessary were located
within the area of the body of the plate. This indicates a feasible design for the body
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dimensions of the plate. Moreover, the absence of applied screws in the body part of
the MMPRP did not lead to the application of further terminal screws compared with
clinical situations when screws were applied in the body of the MMPRP. Furthermore,
in over 80% of the applied MMPRPs’ parasymphysis parts, the terminal screw hole
was trimmed. This was expected because the MMPRP design exceeds the center
line of the mandible, and in most patients the defect dimension does not cross the

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mandible to the contralateral side. The MMPRPs’ ramus design offers a maximum of
five available screw holes for the small type of plate and six screw holes for the

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medium and large types. Of 47 patients receiving a small MMPRP 39 cases (82.98%)
were treated without employing the terminal screw hole of the ramus for plate

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fixation. Interestingly, this trend increased in the medium-sized MMPRPs. In this case
91.80% of the patients were implanted without the terminal screw hole. For large
MMPRPs, none of the patients needed the terminal screw hole for sufficient
osteosynthesis.
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Although the preformed shape of the plate leads to significant reduction in intra-
operative plate handling and bending time, it is still necessary to trim the plate in
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order to fit the patients’ mandible and defect dimension. Aside from the excessive
waste of medical-grade titanium, this implies additional steps to the intra-operative
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handling. With the economic need to reduce the waste of resources and the
emergence of solid, freeform fabrication methods for Ti-alloys, such as electron beam
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melting (EBM) and selective laser melting (SLM), the desire to produce patient-
specific implants and offer the ability to recycle waste powder from the manufacturing
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process increases (Murr et al., 2009). Recent advances in the production and clinical
availability of such patient-specific implants offer new operative workflows and
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promise a variety of benefits, such as a custom fit of the implant to the defect site, a
reduced operation time, and a reduction in resource waste. Ideally, patient-specific
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implants incorporate the advantages of preformed reconstruction plates without the

necessity for intraoperative trimming. This goal is achieved by a virtual design based
on CT scans and following EBM fabrication (Dérand et al., 2012; Gander et al.,
2015). However, major drawbacks of patient-specific implants include higher
manufacturing costs and the limitation to a specific intra-operative situation. In cases
were the projected operation changes, the patient-specific implant might not hold the
potential to adapt to the newly found situation. Taken together, this advocates for the
coexistence of patient-specific implants and preformed reconstruction plates.
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Conclusion
A key feature of preformed reconstruction plates is their immediate availability without
the need for previous planning and manufacturing time. Accordingly, a wide variety of
patients, including emergency cases, can be treated right away with the option to
further adapt the plate according to the intraoperative situation.

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Our clinical analysis of the MatrixMANDIBLE preformed reconstruction plate design
demonstrated a feasible design of the plates’ body dimensions, whereas in over 80%

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of the applied MMPRPs the ramus and parasymphysis parts were subject to
intraoperative trimming. To further optimize the MMPRP design in order to reduce

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intraoperative handling time and prevent loss of medical-grade titanium additional
research and development is required.

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Acknowledgements and conflict of interest statement

This research did not receive any specific grant from funding agencies in the public,
commercial, or not-for-profit sectors. There is no conflict of interest.

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Figure 1 Post-operative radiographic analysis. Orthopantomography was routinely conducted after
mandible reconstruction. Representative samples of small (a), medium (b), and large (c) MMPRPs in
situ.

Figure 2 Screw hole assignment of MMPRPs. Screw holes in the MMPRPs were numbered
consecutively starting with 1 at the center part of the ramus or parasymphysis and ending at the
terminal available screw hole. Screw holes available in the body part of the MMPRPs were numbered
consecutively starting from 1 at the body–parasymphysis intersection and ending with the terminal
available screw hole at the body–ramus intersection (numerical indications on the plate). The shown
sample of a medium-sized MMPRP had a terminal screw placed at hole 4 in the ramus, hole 7 in the
body, and hole 8 in the parasymphysis (screw-caddy). Adapted from ©Synthes, West Chester, PA,

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USA.

Figure 3 Ramus (a) and parasymphysis (b) screw hole assignment of MMPRPs. (a) Statistical
analysis revealed that the median of the utilized and consecutively numbered screw holes of the

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ramus was 3.8 in all MMPRP sizes (S = small, M = medium, L = large). The mean screw hole was 3.4
(SD 1.4) in the small MMPRP, 4.0 (SD 1.3) in the medium, and 3.9 (SD 1.1) in the large. (b)
Regarding the screw hole assignment of the parasymphysis part of the MMPRP, the median of the

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utilized and consecutively numbered screw holes was 5.2 in all MMPRP sizes (S = small, M =
medium, L = large). The mean screw hole was 4.9 (SD 3.1) in the small MMPRP, 5.5 (SD 2.8) in the
medium, and 5.2 (SD 3) in the large.

Figure 4 Distribution of the utilized MMPRP screw hole at the ramus (a) and parasymphysis (b).

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Statistical analysis showed the density for each patient collective of the most terminal utilized screw
holes in relation to the three different-sized MMPRPs (S = small, M = medium, L = large).
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Figure 5 Screw hole assignment and distribution in the body part of the MMPRP. (a) Statistical
analysis of the screw hole assignment revealed that the median of the utilized and consecutively
numbered screw holes of the body was 3.7 in all MMPRP sizes (S = small, M = medium, L = large).
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The mean screw hole was 3.0 (SD 3.0) in the small MMPRP, 3.9 (SD 3.1) in the medium, and 4.5 (SD
3.2) in the large. (b) Frequency for each patient collective of the most utilized screw holes in relation to
the three different-sized MMPRPs (S = small, M = medium, L = large).
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Figure 6 Correlation of MMPRP screw hole utilization in the body part of the plate and
distribution of utilized screw holes at the ramus (a) and parasymphysis (b). Statistical analysis
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showed that in all three sizes there was no significant evidence that the application of screws in the
body part of the MMPRP (1) led to the application of further terminal screws compared with clinical
situations when screws were applied in the body of the MMPRP (0).
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