Reliability of a Trapezium Miniplate with Endoscope-Assisted Internal Fixation in Mandibular Subcondylar Fractures: A Three-Dimensional Analysis

3

]. The application of miniplates fixed with screws is considered the gold standard

for ORIF in mandibular surgery [

4

,

5

]. Thus, numerous miniplate designs have been intro-

duced during the past decades, and recently, their efficacies have been studied to examine
biomechanical stability and surgical simplicity [

6

9

]. Previous biomechanical studies have

confirmed the reliability of condyle fixation via two miniplates for subcondylar fractures for

withstanding the compression and tension forces within physiological limitations. [

Meyer at al. [

] demonstrated that the trapezoidal plate provided sufficient rigidity for the

fixation of subcondylar fractures. Darwich et al. [

13

] claimed that trapezoidal plates are

superior to two miniplates.

Recently, with the emergence of endoscopy-assisted surgery, problems of inadequate

surgical view and limited workspace, which are critical disadvantages of intraoral surgery,
have been overcome [

14

https://www.mdpi.com/journal/jcm

16

]. Endoscopy-assisted open reduction and internal fixation

(EAORIF) of mandibular condylar fractures has resulted in satisfactory postoperative

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outcomes [

17

]. A previous study regarding the miniplate system in EAORIF showed that

biodegradable plates are as reliable as metal miniplates [

18

]. However, there are insufficient

data for appropriate miniplate designs for EAORIF. Therefore, the present study evaluated
the clinical use of a newly developed single trapezium miniplate (Jeil Co., Seoul, Korea)
applied through a transoral endoscopy-assisted approach and attempted to present clinical
and three dimensional (3D) anaylsis follow-up results.

2. Materials and Methods

We retrospectively reviewed patients who had undergone a uniform surgical tech-

nique between 2015 and 2018, consisting of an endoscopy-assisted transoral approach

with combination fixation using a mono-cortical single trapezium miniplate, with at least

6 months of postoperative follow-up. A total of 18 patients with mandibular subcondylar
fractures (12 males and 6 females) between 18–70 years old (mean age 43.83 years old) were
included. All patients underwent surgery at the Department of Oral and Maxillofacial
Surgery of the Wonju Severance Christian Hospital. The study protocol was reviewed
and approved by the Institutional Review Board of Yonsei University Wonju Severance
Christian Hospital, Wonju, Korea (CR319018).

In the trapezium plate, the plate arms were designed according to the ideal line of

osteosynthesis introduced in Meyer’s study [

19

]. Both vertical arms were designed parallel

to the compression lines, while the upper and lower horizontal lines were designed along
the traction lines. Two types of trapezium plates were designed, which differed in the
upper arm size. The arms were similar, but were selectively used in high and low condylar
fractures. The plate was 1 mm thick, 13.2 mm long, and 4–5.2 mm wide at the top and

13.2 mm wide at the base. Four holes were located at each corner of the trapezium plate
(Figure

1

).

Figure 1.

Trapezium plate shape and dimensions. (

A

) Two subtypes of trapezium plate. (

B

) Numerical

description of each trapezium plate. (

C

) Trapezium plate applied to a rapid prototype model.

All of the patients received general anesthesia. Lidocaine with 1:100,000 epinephrine

was injected into the muco-vestibular area along the mandibular ramus. In most cases,

anchor screws were located at the upper and lower interdental alveoli for maxillomandibu-
lar fixation (MMF). A linear mucosal incision was made over the buccal vestibule and
over the anterior border of the ramus, similar to orthognathic surgery. The portion of
the mandibular angle and the lateral aspect of the ramus along the fractured subcondylar

portion were then exposed by raising the mucoperiosteal flap and masseter muscles using

a surgical curette, periosteal elevator, and ramus stripper. A stab incision was made at the
ipsilateral overlying skin, according to the level of the fracture line. The trochar system was
inserted transbuccally, providing adequate space between the bone and overlying tissue for
endoscopic instruments. Under endoscopic visualization of the fractured site, manipulation
of the proximal segment for proper reduction was attempted with a trochar shank. When
rough reduction was performed, proper occlusion was manually manipulated. To con-
firm proper reduction and occlusion, a trapezium plate was placed between the trochar
shank and the proximal segment of the bone. After temporary intermaxillary fixation

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via wire engagement on the corresponding upper and lower anchor screws, two holes in

the proximal segment were drilled, and screws were inserted into the upper corners of
each hole. Thorough determination of the correct anatomical reduction, especially proper
alignment of the posterior border of the ramus, was achieved endoscopically. Finally,
two holes in the distal fragment were drilled, and screws were inserted. The MMF was
removed, and occlusion was confirmed. The outcome of fracture reduction and fixation

was verified endoscopically (Karl Storz, Germany) (Figure

2

). If necessary, the fixation

position was adjusted by slightly loosening and retightening the screws (Figure

3

). Wound

closure was usually performed using 4-0 vicryl, and a silastic drain was inserted to prevent

postoperative hematoma and minor hemorrhage. A liquid diet with intermaxillary elastic

engagement was strictly maintained for 2 weeks after the operation. To ensure mouth
opening and prevent temporomandibular joint ankylosis, a soft diet was recommended
from the third week onwards. The trapezium plate was removed after a minimum of
6 months postoperatively using an intraoral and transcutaneous approach.

Figure 2.

Endoscopic view of the trapezium plate after condylar fracture fixation.

Figure 3.

3D reconstruction view. (

A

) Pre-operative 3D view. (

B

) Post-operative 3D view. Using

Mimics, an image of the condylar head collapsing inward before surgery was reproduced, and it was
confirmed that the condylar head was repositioned after surgery.

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Each patient was followed-up with clinical and radiographic evaluations for at least

6 months. Clinical evaluation included stable occlusion, and trismus evaluation by measure-
ments of the maximum interincisal distance, protrusion, lateral excursion, and mandibular
deviation on the mouth opening. Preoperative and postoperative radiographic evaluations

were performed using 3D facial mandible computed tomography (CT) in all patients, along
with panoramic radiography (Figure

4

). Adequate anatomical reduction was evaluated

according to Undt et al. [

3

]. Using 3D simulation in the Mimics medical program, the

ramus height was measured from the top point of the condyle to the gonion, and was
compared with the non-fractured side. Similarly, the program was used to evaluate the
angle of dislocation of the proximal fragment, compared to the contralateral side, using 3D
CT DCM files. The angle was measured from the most posterior point of the condylar head
to that of the fracture line and that of the mandibular angle (Figure

5

). For comparison with

the non-fractured side, the FH-plane was used, and the angle was measured by connecting
the condylion superius to the point where they met the non-operated proximal condyle by
setting a line parallel to the FH-plane and the gonion posterius (Figure

6

).

Figure 4.

X-ray and 3D facial CT view. (

A

) Pre-operative panoramic view. (

B

) Post-operative

panoramic view. (

C

) Pre-operative 3D facial computed tomography scan. (

D

) Post-operative 3D

facial computed tomography scan.

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Figure 5.

Ramus height and angle of dislocation measured on 3D simulation. (

A

) Pre-operative

mandible. (

B

) Post-operative mandible. CO-sup (condylion superius): The most superior point of

the condylar head. CO-post (condylion posterius): The most posterior point of the condylar head.
GO-post (gonion posterius): The most posterior point on the mandibular angle.

Figure 6.

The red plane indicates the FH-plane, orbitale to porion. The blue plane is parallel to the

FH-plane and passes through the posterior point of the subcondylar fracture line.

Statistical analysis was performed using the collected data. Descriptive statistics of

the patients’ average mouth opening and protrusive and lateral excursion of the mandible

were analyzed to evaluate the functional recovery of mandibular movement. The Wilcoxon

signed-rank test was performed to compare variables between the fractured and non-
fractured sites. The ramus height and angle of dislocation of the operated side and those of
the non-fractured side were determined as variables.

3. Results

3.1. Clinical Evaluation

The operation time ranged between 104 and 128 min, depending on the degree of

displacement or the existence of other fracture sites. The plate was easily manipulated
during the operation, and the fractured segments were adequately reduced. None of the

patients showed chronic inflammation, infection, malunion, or nonunion. The plates were

removed in all 18 patients, and no loose screws were found during removal; many of the

patients had bone accumulation over the trapezium plate.

3.2. Functional Evaluation

During the follow-up period (mean follow-up, 12.2 months; range, 6–24 months),

no patient complained of pain or occlusal discomfort. However, postoperatively, two pa-
tients complained of occlusal discomfort, which disappeared after intermaxillary elas-
tic engagement 3–5 days after admission. The mean maximum mouth opening was
24.82

±

1.99 mm immediately after the operation, 32.2

±

1.32 mm 1 month after the opera-

tion, and 41.54

±

2.21 mm 6 months after the operation.

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Protrusive movement and lateral excursion of the mandible varied from 4.5 to 10 mm at

the 6-month follow-up timepoint. Lateral deviation on the mouth opening to the fractured
side was observed in 11 of the 18 patients. The values of postoperative mandibular
movements (maximum mouth opening, protrusion, and lateral excursion) were almost
similar to those of the physiological mandibular movement recommended by Okeson [

20

].

The findings are summarized in Table

1

.

Table 1.

Descriptive statistics.

Variables

Study Population (

n

= 18)

Sex

n

(%)

Men

12 (66.67)

Women

6 (33.33)

Age (year)

Mean

±

SD

43.83

±

15.76

Median (min–max)

47.00 (18.00–70.00)

Post-operative MMO (mm)

Mean

±

SD

24.82

±

1.99

Median (min–max)

24.90 (21.20–27.90)

Post-operative MMO (1 month) (mm)

Mean

±

SD

32.23

±

1.32

Median (min–max)

32.50 (30.30–34.30)

Post-operative MMO (6 months) (mm)

Mean

±

SD

41.54

±

2.21

Median (min–max)

42.70 (37.20–47.80)

Mean protrusion (6 months) (mm)

Mean

±

SD

7.39

±

1.60

Median (min–max)

8.20 (4.00–10.50)

Mean lateral excursion to the right

(6 months) (mm)

Mean

±

SD

7.28

±

1.18

Median (min–max)

7.45 (4.60–9.50)

Mean lateral excursion to the left

(6 months) (mm)

Mean

±

SD

7.13

±

1.51

Median (min–max)

7.05 (4.50–10.20)

3.3. Radiographic Evaluation

Anatomical reduction was confirmed via 3D facial mandible computed tomography.

The postoperative panoramic view revealed no significant numerical gap between the

ramus heights. At 6 months follow-up, the ramus height was retained in most patients

(83%). Based on the angle of dislocation in the panoramic view, good anatomic reduction
(angle 0

◦

to 20

◦

) was achieved postoperatively in all patients. Radiography revealed no

plate fracture or plate bending in any patients.

3.4. Statistical Evaluation

The Wilcoxon signed rank test was performed between two subgroups (operated

and non-operated sides) in two categories (ramus height and angle of dislocation). At a
significance level of 0.05, negative statistical significance was found between the operated
and contralateral sides in both categories (Table

2

).

Table 2.

Comparison between the operated and non-operated sides.

Variables

Non-Operated Side (

n

= 18)

Operated Side (

n

= 18)

p

-Value *

Length (mm)

Mean

±

SD

65.68

±

6.77

65.02

±

6.48

0.205

Median (min–max)

65.33 (52.10–79.40)

66.77 (48.16–74.13)

Angle (n

◦

)

Mean

±

SD

166.31

±

7.10

164.95

±

8.26

0.099

Median (min–max)

168.10 (143.00–175.20)

165.30 (142.50–179.50)

*

p

-value by Wilcoxon signed-rank test.

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4. Discussion

With the development of surgical techniques and instruments, miniplates are a dedi-

cated solution for the fixation of mandibular condylar neck and base fractures. Nevertheless,
endoscopy-assisted ORIF (EAORIF) should not be indicated for all condylar fractures, as it
has limitations in cases with high condylar neck fractures or for comminuted fractures with
insufficient bone mass to tolerate screws and plating; in these cases, closed reduction is pre-
ferred. However, for cases with proper indication, ORIF of the condylar and subcondylar
fractures, rather than closed treatment, should be performed [

21

,

22

]. An intraoral approach

can decrease the risk of nonesthetic surgical outcomes and postoperative complications
such as Frey’s syndrome and facial nerve palsy [

]. Transoral subcondylar surgery

has overcome the limited surgical view via endoscopic assistance, and the need for a small,
manageable osteosynthesis device that can replace conventional two-plate bio-stability
is increasing [

25

27

]. Trapezium plates for subcondylar fractures have many advantages.

First, its shape designs with four arms can be placed at the compression and traction lines.
Second, they are easy to manipulate and require less time for placing, but are as stable as
the two single miniplate system biomechanics, which requires the drilling of eight holes
and screw insertion [

]. Radiographic findings confirmed proper anatomical reduc-

tion, and no permanent functional complications occurred in our patient cohort. Minor
deviations were found in five patients, but no functional or esthetic dissatisfaction was
noted. Lata et al. [

30

] compared delta and trapezoidal plates, and found that patients

treated with delta plates showed a significant improvement at all intervals in contrast with
the trapezoidal plate, which did not show a significant improvement in the mouth opening
from 6 weeks to 3 months. Burkhard et al. [

9

] found that deltoid and trapezoid plates seem

to perform equally in the treatment of condyle neck and base fractures. Hochban et al. [

4

emphasized that deviations from the anatomically correct position did not affect the func-
tion of the temporomandibular joint. In our patient cohort, trismus relief and restoration
of the mouth opening were observed within 6 months after operation. Six months after
surgery, the amount of MMO, protrusion, and lateral movement showed good results.

There is a time difference between the lateral and medial overrides, but it is sufficiently

overcome. In our patient cohort, the presence of additional distant fractures of the mandible
showed good results. The functional parameters of protrusive and lateral excursion of the
mandible were similar between our patients and the various treatment cohorts reported

previously [

]. Kang et al. [

] evaluated the complications of EAORIF of mandibular

condylar fractures. The long-term complication rate was much lower than the temporary
complication rate, except for cases where malreduction or refracture occurred. EAORIF
should be considered reliable for the treatment of condylar fractures, but intensive training
and equipment are required.

The statistical insignificance observed between the operated and non-operated sides re-

garding the ramus height and angle of dislocation indicated consistent operation outcomes,
accompanied with anatomic reduction and rigid fixation.

Plate fracture or bending and screw loosening have been observed in previous studies;

however, none of these complications occurred in our study. Occasionally, excessive bone
accumulation over the trapezium plate interfered with the process of plate and screw
removal, which implies vigorous osteogenesis around the fixation site. The two types of
trapezium plates differ in the upper horizontal arm length. Therefore, they can be applied
to most open subcondylar fractures with various fracture line locations.

The biostability and durability of the trapezium plates were evaluated by Darwich et al. [

13

].

Five plating techniques (single straight plate, two parallel straight plates, two divergent
straight plates, trapezoid plate, and square plate) were compared for the fixation of uni-
lateral mandibular subcondylar fractures with finite element analysis. Among these, the
trapezoid plate showed the least micro-mobility and strain on the underlying bones for
fixation [

29

]. Sikora et al. [

7

] summarized clinical trials regarding the use of various types

of 3D condylar mini-plates (trapezoid, deltoid, rhombus, strut, nine-hole trapezoid, and
lambda). There are no convincing data that the number of reoperations depends on the

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type of 3D mini-plate used and clinical fractures of 3D mini-plates are extremely rare, in
contrast to the fairly frequent fractures of straight miniplates. The trapezium plate can be
applied to various subcondylar fractures. It is accurately designed according to the ideal
tension and compression line of the mandible, and can tolerate various forms of loads,

with the highest tensile strain occurring at the anterior and lateral surfaces and the highest

compressive strains on the posterior surface. Although there is a learning curve for our

protocol, the surgical outcome and time efficiency have been verified throughout the past
years. The clinical, functional, and radiologic outcomes are consistent with those from
previous studies.

However, there are possible complications of this surgical technique. In severely

dislocated and comminuted fractures, if the extraoral approach for the endoscopic-assisted
treatment of subcondylar fractures is indicated, then facial nerve damage may occur.
Subcondylar fractures with medially displaced fragments are more challenging to reduce

within the narrow sight under the endoscopic view. So, if an unskilled surgeon performs

the operation, re-fracture due to screw loosening, malocclusion, deviation, trismus, and
temporomandibular joint disease may occur.

This study has some limitations. First, the number of patients undergoing this surgery

is not enough. Second, in the 3D analysis of the position of the condyle after surgery, there
is a limit to the analysis of angles in various directions, such as the mesial and lateral side.
Moreover, the results for the follow-up of long-term clinical evaluation and functional
evaluation are insufficient.

5. Conclusions

In conclusion, the use of a trapezium plate with endoscopy-assisted ORIF can be

recommended for subcondylar fractures. However, the use of a trapezium with EAORIF
has limitations in tolerating screws and plating in cases of high condylar neck fractures
or comminuted fractures with insufficient bone mass. Trapezoid shape designs with four
arms can be placed at the compression and traction lines; thus, a sufficient fixing force can
be achieved even with a small number of screws, with equal stability to other miniplate
systems. Considering these advantages, our method can be recommended for the treatment
of patients with subcondylar fractures.

Author Contributions:

Conceptualization, C.L.; methodology, C.L.; software, Y.-Q.F. and S.D.; val-

idation, C.L.; formal analysis, S.J. and O.H.N.; investigation, S.J. and O.H.N.; resources, C.L.; data
curation, C.L.; writing—original draft preparation, S.J., O.H.N. and C.L.; writing—review and editing,
S.J., O.H.N. and C.L.; visualization, O.H.N.; supervision, C.L. All authors have read and agreed of
the published version of the manuscript.

Funding:

This research received no external funding.

Institutional Review Board Statement:

The study was conducted in accordance with the guide-

lines of the Declaration of Helsinki and was approved by the Institutional Review Board of Yonsei
University of Wonju Severance Christian Hospital, Korea (CR319018).

Informed Consent Statement:

Patient consent was waived due to the retrospective nature of this study.

Data Availability Statement:

Data are available upon reasonable request.

Conflicts of Interest:

The authors declare no conflict of interest.

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