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What is the most stable fixation technique for mandibular condyle fracture

Hisham Marwan, DDS, Yoh Sawatari, DDS FACS

PII: S0278-2391(19)30897-3
DOI: https://doi.org/10.1016/j.joms.2019.07.012
Reference: YJOMS 58866

To appear in: Journal of Oral and Maxillofacial Surgery

Received Date: 12 May 2019

Revised Date: 22 July 2019
Accepted Date: 23 July 2019

Please cite this article as: Marwan H, Sawatari Y, What is the most stable fixation technique
for mandibular condyle fracture, Journal of Oral and Maxillofacial Surgery (2019), doi: https://
doi.org/10.1016/j.joms.2019.07.012.

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© 2019 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial
Surgeons
 What is the most stable fixation technique for mandibular condyle fracture?

Authors:
Hisham Marwan DDS1,2, Yoh Sawatari DDS FACS3

INSTITUTIONAL AFFILIATION:
1- University of Texas Medical Branch at Galveston
2- King Abdulaziz University Kingdom of Saudi Arabia
3- University of Miami- Miller School of Medicine

AUTHORS’ TITLES:
1- Hisham Marwan
Assistant Professor of Surgery, Division of Oral and Maxillofacial Surgery
Oral/Head&Neck Oncology and Microvascular Surgery
University of Texas Medical Branch at Galveston

2- Yoh Sawatari:
Associate Professor of Surgery, Division of Oral and Maxillofacial Surgery
Residency Program Director
University of Miami- Miller School of Medicine

CORRESPONDING AUTHOR AND CONTACT INFORMATION:

Hisham Marwan, DDS
Assistant Professor of Surgery
Division of Oral and Maxillofacial Surgery
University of Texas Medical Branch
301 University Boulevard
Galveston, Texas 77555-0531
Ph: 409-772-1546
Fax: 409-747-7378
Email address: himarwan@utmb.edu

DISCLOSURES

None of the authors have relationships to disclose

What is the Most Stable Fixation Technique for Mandibular Condyle
Fracture?

Abstract:

Introduction:

Mandibular condylar fractures are relatively common fractures accounting for 29-
52% of all
mandibular fractures. Recently, the debate between close versus open treatment of
the
condylar fracture has shifted away toward more specific surgical question
concerning the
number and pattern of fixation method for the condylar region. We have
attempted to resolve
the controversy with the systematic review and meta-analysis. The purpose of this
study is to
compare the outcomes of different means of fixation of mandibular condylar
fracturea.
Method:

The authors conducted an electronic database search for clinical studies

evaluating the stability
of internal fixation of condylar fractures. The search was restricted to studies
published in the
English language between January 2000 and July 2018. The review was
performed according to
the Preferred Reporting Items for Systematic Reviews and Meta-Analysis
(PRISMA) statement
guidelines

Results:

The initial search returned 285 articles published between January 2000 through
July 2018.
After reviewing the full-text article, only 16 studies were deemed eligible for the
review. The
total sample size was N = 831 patients with mandibular subcondylar fractures.
The patients
were classified into 25 groups, based on fixation method, follow up period, use of
intermaxillary fixation, and
associated fractures.

Conclusion:
The results of this systematic review and meta-analysis showed that single plate
fixation is
associated with more complications with poor outcomes odhardware failure,
screw
loosening, and postoperative malocclusion.

Introduction:

Mandibular condylar fractures are relatively common fractures accounting for 29-
52% of all
mandibular fractures 1,2. Treatment for condylar fractures remains controversial;
however, the
results of open reduction have become more favorable3,4,5, 6. In addition, it has
been established
that open reduction and internal fixation is the only reduction method that can
provide precise
alignment of the fractured segments7.

Recently, attention has shifted away from the debate between closed versus open
treatment of the
condylar fracture and moved more towards specific surgical questions regarding
the number and
pattern of fixation for the condylar region (base, middle, high neck and head of
the condyle).
Various fixation methods have been reported in the literature including wires,
single or double
mini plates, lag screws, and three-dimensional plates8,9,10,11. Plausibly, if a single
miniplate can
provide similar or better results than two mini-plates, or the other 3-dimensional
plates; this will
reduce the cost of the procedure and reduce the operating room time.

When reviewing the literature, there are several shortcomings in most of the
reported studies,
including the lack of randomization and inconsistent classification schemes used
by different
authors. A search of the literature did not reveal any systematic review with a
meta-analysis that
compared different fixation techniques of the condylar fractures. As a result, an
effort was made
to resolve this condylar fixation controversy with the systematic review and meta-
analysis. The
purpose of this study was to compare the outcomes of different fixation methods
of mandibular
condylar fractures. The null hypothesis was that there is no difference in the
outcomes between
single mini plate fixation and the fixation of the subcondylar fracture with
different plating
techniques. In addition, the specific aim of the study was to compare the
outcomes of the
different fixation schemes in regard to the development of malocclusion, failure
of the fixation
plates, loosening of the screws, and the use of postoperative intermaxillary
fixation (IMF).

Method:

The authors conducted a comprehensive electronic database search for clinical

studies evaluating
the stability of internal fixation of condylar fractures. The following databases
were used:
PubMed, EMBASE , and Google Scholar databases. The search was restricted to
studies
published in the English language between January 2000 and July 2018. The
review was
performed according to the Preferred Reporting Items for Systematic Reviews and
Meta-
Analysis (PRISMA) statement guidelines12.

The following keywords were used in the search: 1- “Internal fixation” AND
“Mandibular
Condylar Fracture”; 2- “One miniplate compared with two” AND “Mandibular
condylar
fracture”; 3- “Single miniplate compared with double miniplate” AND
“Mandibular Condylar
fracture” AND “postoperative complications”;4- “Mandibular condylar fracture”
AND “Open
reduction and internal fixation”;5- “Mandibular condylar fracture” AND “Three
dimensional
plate”; 6- “ Clinical and radiological outcomes” AND “ Mandibular condylar
fracture”; 7- “
Treatment outcomes” AND “ Mandibular condylar fractures”

For the initial selection of the articles, both authors independently reviewed the
title and the
abstract of the article based on established inclusion criteria: 1-Studies done in
human and
published in English; 2-Adults patients with mandibular condylar fracture treated
with open
reduction and internal fixation; 3-Internal fixation using one miniplate, two mini
plates, or 3-D
design (Delta, TriLock plate, Trapezoid plate, mini-dynamic compression plate,
and strut
plates); 4- reported outcomes regarding the period of postoperative
IMF, postoperative malocclusion, failure of hardware, and screw loosening.

Literature reviews, brief case reports, abstract-only articles, and articles written in
a language
other than English were excluded from the study. In addition, exclusion criteria
also included
studies performed using animal mandibles, studies that evaluated degradable
fixation systems,
studies that used non-titanium plates and screws and studies in which fixation of
the fracture was
completed with wires or screws alone. Finally, studies that did not report the long-
term
outcomes of the hardware were excluded.

After the initial selection, the authors carefully reviewed the full texts of the
selected articles and
identified those for final review based on the established inclusion criteria. The
following data
were extracted from the studies included in the final analysis: author(s), year of
publication,
design of the study, number of patients, gender, follow up period, associated
fractures, surgical
approach, mean operative time (in minutes), fixation method, postoperative IMF
period, the
presence of postoperative malocclusion/dislocation of fracture segment, hardware
failure and
loosening of the screws. Further discussion of the data resolved any discrepancies
between the
reviewers.

The quality and the risk of bias of each study were assessed using the Preferred
Reporting Items
for Systematic Review and Meta-analysis (PRISMA) to verify the strength of the
scientific
evidence13. The potential risk of bias of each study was assessed using the
following criteria:
randomization, defined inclusion and exclusion criteria, report losses of follow
up, statistical
analysis, and validated measurement. Low risk of bias was defined as having all
the criteria
mentioned above. A study that lacks one of these criteria was classified as having
a moderate
risk, and if two or more of these criteria are lacking the study was considered to
have a high risk
of bias. Moreover, we drew a funnel plot asymmetry of which may indicate
publication bias and
other related biases to the size of the sample, and it was interpreted using the
methods
described by Sterne & Egger14.

Regarding the statistical analysis, the mean percentage of cases within each
outcome variable
were computed for each group of patients listed in Table 1, classified by the three
predictor
variables (use of IMF, follow up period, and associated fractures). Forest plots
were constructed,
to visually compare the mean percentages of cases within each outcome, with
respect to each
predictor variable. The general linear model was used to estimate the effect size,
given by R2 =
the proportion of variance in the outcome variables explained by the predictor
variables) for each
plot. The R2 values were interpreted assuming 4% = small; 25% = moderate; and
64% =
large15,16. The meta-analysis was made only if the studies were similar
comparisons and were
reporting the same outcome measures. The meta-analysis was conducted using
Minitab 17.3
software.
Results:

The initial search returned 285 articles published between January 2000 through
July 2018.
Based on the title and the abstract, full-text articles were acquired for 62 studies.
After
reviewing the full-text article, only 16 studies were deemed eligible for the
review7,11,17,18,19,20,21,22,23,24,25,26,27,28,29,30 (Fig.1)

The meta-analysis was conducted using primary data extracted from the sources
listed in Table
1. The total sample size was N = 831 patients with mandibular subcondylar
fractures. The
patients were classified into 25 groups, based on fixation method, follow up
period, use of
IMF, and associated fractures. Detailed characteristics of the studies are shown in
Table 1. Two
studies are randomized clinical studies (RCS)17,27, 3 prospective clinical studies
(PCS)20,23,28, and
11 retrospective studies (RS)7,11,18, 19,21, 22,24,25,26,29,30.

The fixation methods were Strut plate (1 sample) (Figure 2); Delta plate (3
groups); Multidynamic compression (2 groups);Modus nonlocking plate (1
sample); Single miniplate (6 groups);Trapezoidal plate (4 groups) ( Figure 3) ;
Trilock plate (2 groups); and Two 2.0 miniplates (6 groups) ( Figure 4). The use
of postoperative intermaxillary fixation (IMF) was classified as Yes, No, or Not
mentioned (NM). The follow up period, which ranged from 3 months to 90
months, was classified into < 1 year and ≥ 1 year. The associated fractures (e.g.,
parasymphysis, symphysis; midface, mandibular angle, mandibular body,
maxilla, zygoma, coronoid, multiple) were classified as Yes, No, or Not
Mentioned (NM). The three outcome variables were the proportions of hardware
failures, screw loosening, and malocclusions, expressed as percentages of the
group sizes listed in Table 1

Only 4 studies out of the 16 showed a low risk of bias20,23,27,28, 2 studies showed a
moderate
risk 18, 19 and 10 studies showed a high risk of bias7,11,17,21,22,24,25,26,29,30. Table 2
summarizes the
scoring for the risk of bias within the studies.

Hardware Failure:
Figure 5 shows that the fixation method, combined with the use of IMF, had a
moderate effect
(R2 = 38.5%) on hardware failures. The fixation methods with the fewest
proportion of hardware
failures, less than the Grand Mean (6.5%), included trapezoidal plate (without
IMF); strut plate
(without IMF), delta plate (with IMF); and two miniplates (without IMF). The
fixation methods
with the highest proportion of hardware failures, greater than 6.5%, were the
minidynamic
compression plate (without IMF), and the single miniplate (with or without IMF).

Further analysis shows that these results did not change with the follow-up.
Figure 6 shows that
the fixation method combined with the follow-up period (< 1 year or ≥ 1 year)
had a moderate
effect (R2 = 31.5 %) on hardware failure. The fixation methods with the fewest
proportion of
hardware failures, less than the Grand Mean (6.5%) were trapezoidal plate, trilock
plate (<
1Year), modus nonlocking plate (> 1 year), strut plate (< 1 year), delta plate (≥ 1
year), and two
miniplates (≥ 1 year). The fixation methods with the highest proportions of
hardware failures,
greater than 6.5%, were the minidynamic compression (> 1 year) and the single
miniplate (< 1 and ≥ 1
year).

Also, the presence of associated fracture had a moderate effect on hardware

failure. Figure 7
shows that the fixation method combined with associated fractures (including
symphysis,
parasymphysis, mandibular body, coronoid process, mandibular angle, midface,
and multiple)
had a moderate effect (R2 = 34.9%) on hardware failures. The fixation methods
with the fewest
proportion of hardware failures with associated fractures (denoted by “Yes” in
Figure 7), less
than the Grand Mean (6.5%), were trapezoidal plate, delta plate, trilock plate,
strut plate, and
two miniplates. The fixation method with the highest proportion of hardware
failures with
associated fractures was the single miniplate.
Loosening of the screws:

Figure 8 shows that the fixation method, combined with the use of IMF had a
small effect (R2
=10.8%) on the loosening of the screws. The fixation methods with the fewest
proportion of
loosening of the screws, less than the Grand Mean (5.6%), when the use of IMF
was known,
were strut Plate (without IMF), two miniplates (with or without IMF) and
minidynamic
compression (without IMF). The fixation methods with the highest proportion of
loosening of the
screws, greater than 5.6%, were the single miniplate (with or without IMF) and
the delta plate (with or
without IMF). Further analysis reveals that these results did not change with the
follow-up.
Figure 9 shows that the fixation method, combined with the follow-up period, had
a minimal
effect (R2< 0.1%) on the infection. There were no data to compare the associated
fractures and
loosening of the screws; therefore, statistical analysis could not be performed

Postoperative malocclusion:

Figure 10 shows that the fixation method, combined with the use of IMF had a
small effect (R2 =
6.4%) on malocclusion. The fixation methods with the fewest proportion of
malocclusion, less
than the Grand Mean (11.7%), were the minidynamic compression (without IMF),
two miniplates
(without IMF), trapezoid plate (without IMF), and the delta plate (9.5%).
Conversely, the fixation
method with the highest proportion of malocclusion (greater than 11.7%) when
IMF was known,
was the single miniplate (with or without IMF). Again, these effects did not
change with
the follow-up, as shown in Figure 11.

When associated fractures were included in the analysis; the results reveal a small
effect on the
postoperative malocclusion. Figure 12 shows that the fixation method, combined
with the
presence of associated fractures had a small effect (R2 = 10.0%) on the
malocclusion. The
fixation methods with the fewest proportion of malocclusion, less than the Grand
Mean (11.7%),
when associated fractures were known, included the trapezoidal plate and trilock
plate. The
fixation methods with the highest proportion of malocclusion, greater than 11.7%,
were the delta
plate and single miniplate.

Publication Bias:

Figures 13, 14, and 15 display funnel plots, illustrating the relationships between
the sample
sizes and the proportions of cases with hardware failure, loosening of the screws,
or
malocclusion classified by each fixation method. The pattern of points in the
funnel plots may
indicate that the estimates of the proportions of cases could be biased.

Discussion:

The ideal design for internal fixation of the mandibular condylar fracture is yet to
be identified.
There are several shortcomings in most studies reported in the literature.
Therefore, the purpose
of this systematic review is to compare the outcomes, if applicable, between the
different fixation schemes. The null hypothesis was that there is no difference in
the outcomes
between single miniplate fixation and the other designs. The specific aim was to
compare the
outcomes concerning hardware failure, infection/screw loosening, and
postoperative
malocclusion. The results of this systematic review and meta-analysis revealed
that single plate
fixation is associated with more complications with poor outcomes regarding
hardware failure,
screw lessening, and postoperative malocclusion.

It is well established that stable internal fixation is of paramount importance in

bone healing after
sustaining traumatic facial bone fractures. Clinical studies have shown that a
single plate fixation
of the condylar fracture will not provide adequate stability, and it is more prone to
postoperative
complications. In addition, single plate fixation does not comply with the
osteosynthesis
principles regarding the functional stability7,20,22. Several investigators have found
that the two
miniplate fixation technique, with the application of the second plate inferior to
the sigmoid
notch, provides better stability 6,23,24. Also, three-dimensional plate designs are
available in cases
in which the condylar neck is narrow, and those plates are beneficial during
endoscopic assisted
condylar fracture repair19,30.

The limitations of this study include the paucity of randomized clinical trials. Two
studies were
randomized control studies, 3 were prospective non-randomized clinical studies,
and 11 were
retrospective studies. In addition, only four studies of the 16 showed a low risk of
bias in the
qualitative assessment. The most reliable results of a meta-analysis would be
derived solely from
randomized clinical trials. However, in this study, retrospective studies were also
included due
to the lack of well-designed randomized prospective clinical trials in this
particular topic. Also,
9 of the studies dealt with an additional associated fracture (such as those of
parasymphysis,
symphysis, angle, and midface). The presence of the second fracture, particularly
in the
mandible would confound the outcome data because of the different fixation
requirements.

In conclusion, the result of this study revealed that fixation of the mandibular
condylar fracture
with a single miniplate is associated with higher complication rates, with
increased incidence in
hardware failure, infection/screw loosening, and postoperative malocclusion.
Future well-designed, prospective, randomized controlled trials with extended
follow-up are highly
recommended to answer this question further. Other factors such as the operation
time and the
cost of treatment should also be evaluated to establish the ideal fixation scheme
for
mandibular condylar fracture.

Figure Legends:
Figure 1. Study Selection Process
Figure 2. Design of the Strut Plate
Figure 3. Design of the trapezoidal plate
Figure 4. Position of the Two 2.0 miniplates
Figure 5. Effects of fixation method and use of IMF on hardware failure
Figure 6. Effects of fixation method and follow-up period (years) on hardware
failure
Figure 7. Effects of fixation method and associated fractures on hardware failure
Figure 8. Effects of fixation method and use of IMF on loosening of the screws
Figure 9. Effects of fixation method and follow up period (years) on Loosening of
the screws
Figure 10. Effects of fixation method and use of IMF on malocclusion
Figure11. Effects of fixation method and follow up period (years) on
malocclusion
Figure 12. Effects of fixation method and associated fractures on malocclusion
Figure 13. Funnel plot for hardware failure
Figure 14 Funnel plot for loosening of the screws
Figure 15. Funnel plot for postoperative malocclusion
Table 1. Studies included, Studies design, fixation methods, and predictor
variables
Table 2. Quality assessment of the studies included
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Table 1

Studies included, Studies design, fixation methods, and predictor variables

First Author Year Group Fixation Method Follow Up Use of Associated Study Design
size (Years) MMF Fractures
Zrounba 2014 15 Delta plate ≥1 No Yes RS
Sikora 2016 42 Delta plate <1 Yes Yes RS
Lauer 2007 16 Delta plate <1 NM Yes RS
Minidynamic
Choi 2001 13 compression <1 NM NM RS
Minidynamic
Miloro 2003 4 compression <1 No NM RS
Modus nonlocking
Seemann 2009 74 plate <1 NM NM RCS
Rai 2012 15 Single miniplate <1 Yes Yes RCS
Gerbino 2008 43 Single miniplate ≥1 Yes NM RS
Jensen 2006 15 Single miniplate ≥1 Yes Yes RS
Handschel 2012 41 Single miniplate ≥1 NM NM RS
Choi 2001 17 Single miniplate <1 No NM RS
Vesnaver 2005 17 Single miniplate ≥1 No Yes PCS
Lechler 2018 30 Strut plate <1 No Yes RS
Chaudhary 2015 15 Trapezoidal plate <1 NM NM PCS
Zrounba 2014 126 Trapezoidal plate ≥1 No Yes RS
Handschel 2012 23 Trapezoidal plate ≥1 NM NM RS
Meyer 2008 64 Trapezoidal plate ≥1 No Yes PCS
Seemann 2007 30 Trilock plate <1 NM Yes RS
Seemann 2009 72 Trilock plate <1 NM NM RCS
Rai 2012 15 Two miniplates <1 Yes Yes RCS
Torre 2015 102 Two miniplates <1 No NM RS
Gerbino 2008 5 Two miniplates ≥1 Yes NM RS
Handschel 2012 10 Two miniplates ≥1 NM NM RS
Choi 2001 10 Two miniplates <1 NM NM RS
Vesnaver 2005 17 Two miniplates ≥1 No NM PCS

RS= Retrospective study, RCS= Randomized controlled study, PCS= Prospective clinical study
NM= Not mentioned
Table 2. Quality assessment of the studies included

First Author Year Randomiz Defined Loss of Validated Statistical Risk of

ation Inclusion/Exclus Follow Measure Analysis Bias
ion ments
Zrounba 2014 No No Yes No No High
Sikora 2016 No Yes Yes No No High
Lauer 2007 No No No No No High
Choi 2001 No No No No No High
Miloro 2003 Yes No No No No High
Rai 2012 Yes Yes Yes No No High
Gerbino 2008 No Yes Yes Yes Yes Moderate
Jensen 2006 No Yes Yes Yes Yes Moderate
Handschel 2012 No No No Yes Yes High
Vesnaver 2005 Yes Yes Yes Yes Yes Low
Lechler 2018 No No No Yes No High
Chaudhary 2015 Yes Yes Yes Yes Yes Low
Meyer 2008 Yes Yes Yes Yes Yes Low
Seemann 2007 No Yes Yes No No High
Seemann 2009 Yes Yes Yes Yes Yes Low
Torre 2015 No Yes Yes No No High
 Records identified via database searching:
PubMed= 126
EMBASE= 113
Google Scholar= 46
Total= 285

223 studies were excluded based on

duplication, non-full text articles and
non-relevant (dealt with other topics)

62 Articles included based on the title and

abstract

46 articles did not fulfil the inclusion

criteria after screening the full text
1- Studies in Human adults and
written in English
2- ORIF of the condylar fracture
3- Using of titanium plates for
fixation
4- Reporting of the outcomes

16 Articles included in the systematic review