Remove Miniplates

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YIJOM-3983; No of Pages 6

Int. J. Oral Maxillofac. Surg. 2018; xxx: xxx–xxx


https://doi.org/10.1016/j.ijom.2018.07.001, available online at https://www.sciencedirect.com

Clinical Paper
Orthognathic Surgery

Is the removal of osteosynthesis S. Sukegawa1, T. Kanno1,2,


Y. Manabe3, K. Matsumoto1,
Y. Sukegawa-Takahashi1,
M. Masui1, Y. Furuki1
plates after orthognathic 1
Division of Oral and Maxillofacial Surgery,
Kagawa Prefectural Central Hospital,
Takamatsu, Kagawa, Japan; 2Department of

surgery necessary? Oral and Maxillofacial Surgery, Shimane


University Faculty of Medicine, Shimane,
Japan; 3Admission Centre, Kagawa

Retrospective long-term University, Takamatsu, Kagawa, Japan

follow-up study
S. Sukegawa, T. Kanno, Y. Manabe, K. Matsumoto, Y. Sukegawa-Takahashi, M.
Masui, Y. Furuki: Is the removal of osteosynthesis plates after orthognathic surgery
necessary? Retrospective long-term
follow-up study. Int. J. Oral Maxillofac. Surg. 2018; xxx: xxx–xxx. ã 2018
International Association of Oral and Maxillofacial Surgeons. Published by Elsevier
Ltd. All rights reserved.

Abstract. The removal of titanium miniplates is a controversial topic in oral and


maxillofacial surgery. This retrospective study examined the timing of and reasons
for titanium plate removal after orthognathic surgery. The study included 240
orthognathic surgery patients (71 male, 169 female; age range 16–55 years, mean
25.0  8.8 years) who had maxillofacial osteosynthesis plates inserted or inserted
and then removed at the Division of Oral and Maxillofacial Surgery, Kagawa
Prefectural Central Hospital, between April 2003 and March 2017. During the study
period, a total of 717 miniplates were inserted in the 240 patients, and 71 of the
patients (29.6%) had 236 plates (32.9%) removed. Ten patients (14.1%) had their
plates removed within a year due to early complications. Although no patient had
their plate removed due to complications at 1–5 years postoperative, a further 14
patients (19.7%) had their plates removed after more than 5 years of long-term
follow-up due to plate-related complications. Complications requiring plate
removal were evidently biphasic, occurring within 1 year after the operation and at Key words: orthognathic surgery;
5 years after the operation. Therefore, after confirming postoperative bone plate removal; complications.
healing, it is necessary to explain to patients the risks of plate removal and the
importance of long-term follow-up. Accepted for publication 2 July 2018

Osteosynthesis using a titanium miniplate duced for use in the oral and maxillofacial initially used were Vitallium and stainless
system is now standard practice in many region in the late 1970s1; since then, sev- steel, followed by titanium and its alloys2.
maxillofacial procedures in orthognathic eral systems have been developed for Laboratory and clinical evidence confirms
surgery. Rigid internal fixation was intro- orthognathic surgery. Metallic materials the histocompatibility and high corrosion

0901-5027/000001+06 ã 2018 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Sukegawa S, et al. Is the removal of osteosynthesis plates after orthognathic surgery necessary?
Retrospective long-term follow-up study, Int J Oral Maxillofac Surg (2018), https://doi.org/10.1016/j.ijom.2018.07.001
YIJOM-3983; No of Pages 6

2 Sukegawa et al.

resistance of titanium and its alloys in the The main outcome variable was titani- experienced any problems. Clinical and
human body3,4. Therefore, standard osteo- um osteosynthesis plate removal. Second- radiological assessments were planned at
synthesis materials are now made of tita- ary outcomes were the indication for plate 1 and 2 weeks after surgery and then at 6,
nium for its strength and biocompatibility. removal, time between insertion and re- 12, and 18 months, followed by a clinical
However, inserting a titanium miniplate moval, and the cause of plate removal. evaluation every other year. Patients for
into a non-sterilized site with indigenous This study was approved by the Ethics whom attending follow-up was difficult
bacteria in the oral cavity and exposing it Committee of Kagawa Prefectural Central were contacted by the hospital and
to the occlusal forces associated with nor- Hospital. All patients provided written instructed to seek medical attention in
mal maxillofacial function suggests that informed consent. the event of a problem occurring. A mini-
the use of titanium plates is not without the mum follow-up period of 6 months was
risk of complications, including plate in- necessary for inclusion in this study.
Surgery and routine postoperative
fection, plate fracture, and screw loosen-
procedures
ing. A few studies have reported that the
absolute need for removal of osteosynth- BSSO procedures were performed by Postoperative plate removal
esis plates placed at each osteotomy site is Obwegeser–Dal Pont method with the The decision regarding postoperative plate
related to infection and plate exposure5. Hunsuck and Epker modification6–8. Le removal was based on patient request or
This retrospective study, including Fort I osteotomies were performed accord- complaint of discomfort, as well as on the
long-term follow-up, examined the timing ing to the method described by Bell et al.9, clinical appearance of infection, an in-
of and reasons for titanium plate removal and genioplasties were performed accord- flammatory reaction, or plate exposure.
after orthognathic surgery in patients with ing to the method described by Trauner Plates in the infected area were removed.
a dentofacial deformity. The aim was to and Obwegeser10. All mandibular third In addition, in cases requiring plate re-
analyze the results of miniplate removal molars were removed preoperatively and moval due to a complication, parts could
and determine the long-term safety and a minimum healing time of 3 months was be repaired or new parts placed as per the
utility of titanium miniplates according to required before mandibular orthognathic patient’s request when performing the
the reasons or symptoms that ultimately surgery. All titanium miniplates were plate removal with the patient under gen-
require plate removal. inserted intraorally without the use of a eral anaesthesia. With regard to the re-
trocar. No specific attempt was made to moval of plates on patient request, this was
position the fixation plates near the inferi- performed for any of the plates, as desired
Patients and methods or border of the mandible, and the plate by the patient.
was inserted in the best position as deter-
Study design and sample
mined by the maxillofacial surgeon. Two
The clinical records and radiographs of L-shaped fixation plates were inserted lat- Evaluation methods
patients with dentofacial deformities eral to the nose aperture, followed by two
were reviewed retrospectively. The sam- L-shaped fixation plates at the zygomati- The primary outcome was the need for
ple of patients was derived from patients comaxillary buttress; one or two straight plate removal after orthognathic surgery;
treated by four expert attending maxillo- fixation plates were also inserted on each this variable was confirmed through a
facial surgeons in a teaching hospital side of the mandible (MatrixORTHOG- reinvestigation of the hospital and outpa-
practice setting. Surgery was performed NATHIC and Compact Lock, DePuy tient records and radiographs. All patients
at a single general hospital (Division of Synthes, Zuchwil, Switzerland; KLS Mar- had undergone a minimum follow-up of
Oral and Maxillofacial Surgery, Kagawa tin, Tuttlingen, Germany; or Walter Lor- 12 months by the end of the study period.
Prefectural Central Hospital, Takamatsu, enz Surgical or Biomet Fixation systems, An infectious reaction was considered
Kagawa, Japan) between April 2003 and Zimmer Biomet Jacksonville, FL, USA). to be present whenever wound dehiscence
March 2017. Before closing the wound, the osteotomies over the plate, granulation tissue at the site
Orthognathic surgery patients who had were rinsed thoroughly with 0.9% saline of the plate, or an intraoral fistula with pus
titanium miniplates placed and who had solution. Suturing was performed with at the site of the plate was observed.
undergone Le Fort I osteotomies, bilateral polyglactin (Vicryl 4–0 or Surgisorb 4– Persistent swelling and redness at the
sagittal split ramus osteotomies (BSSO), 0), with the intention of capturing the osteosynthesis site was considered an in-
and/or genioplasty were evaluated. Only periosteum and mucosa in two layers in flammatory reaction necessitating plate
the records of dentofacial deformity both the maxilla and the mandible. removal, depending on whether it was
patients undergoing orthognathic surgery The same procedures and postoperative accompanied by tenderness over the area.
in which the same operative technique clinical management were utilized in all Furthermore, the maxillofacial surgeons
was applied and for whom the postoperative patients. All patients were administered an judged from their experience whether a
clinical approach to the removal of osteo- intravenous antibiotic during surgery screw was loose or a plate was broken. In
synthesis plates was the same were includ- (cefazolin sodium 1.0 g every 3 h) and addition, permanent plate exposure in the
ed. Patients were excluded if they had during the postoperative period (cefazolin oral cavity was determined by the physi-
undergone previous surgery for dentofacial sodium 1.0 g every 12 h); antibiotics were cian and recorded in the medical records.
deformity or the maxillofacial deformity continued until the third postoperative
was syndromic, cleft-related, post-traumat- day. All patients were also administered
Statistical analysis
ic, or tumour-related. Other standard exclu- intravenous steroids (betamethasone sodi-
sions for elective orthognathic surgery um phosphate 4 mg intraoperatively and The data were entered into a database
included serious cardiovascular diseases, 2 mg twice on postoperative days 1 and 2). using Microsoft Excel (Microsoft Inc.,
respiratory diseases, current use of bispho- Patients were discharged after their sys- Redmond, WA, USA). The database
sphonates, immunosuppressed status, and temic condition had stabilized and were was transferred to JMP version 11.2 for
insulin-requiring diabetes. instructed to return to the hospital if they Mac (SAS Institute Inc., Cary, NC, USA)

Please cite this article in press as: Sukegawa S, et al. Is the removal of osteosynthesis plates after orthognathic surgery necessary?
Retrospective long-term follow-up study, Int J Oral Maxillofac Surg (2018), https://doi.org/10.1016/j.ijom.2018.07.001
YIJOM-3983; No of Pages 6

Osteosynthesis plate removal after surgery 3

for statistical analysis. A P-value of <0.05 Table 1. Analysis of the need for plate removal by presence or not of a complication and
was considered statistically significant. according to patient sex.
Male Female P-value
Results Maxilla Complication 3 12 0.31
No complication 11 16
A total of 240 Japanese patients were Mandible Complication 2 2 0.29
included in this study, 71 male and 169 No complication 8 25
female. They ranged in age from 16 to 55 Chin Complication 1 4 0.83
years (mean age 25.0  8.8 years). During No complication 5 12
the study period, these patients had 717
miniplates inserted, and 71 patients
(29.6%) had 236 miniplates (32.9%) re-
Table 2. Analysis of patients who had plates removed according to age.
moved. In total, 25 male patients (35.2%
of total male patients) and 46 female Age, years
P-value
patients (27.2% of total female patients) Mean  SD Minimum Maximum
required osteosynthesis plate removal,
Maxilla All patients with plate removal 25.1  9.3 16 50
with no significant difference between Complication 25.5  8.0 16 40 0.83
the sexes (P = 0.45). The average age of No complication 24.9  10.1 16 50
the patients in whom the plates were Mandible All patients with plate removal 27.5  9.5 16 50
retained (no plate removal) was Complication 36.5  10.1 26 50 0.048
24.6  8.6 years and the average age of No complication 26.4  9.0 16 48
patients requiring plate removal was Chin All patients with plate removal 25.0  8.0 17 48
25.7  9.2 years; this difference was not Complication 25.2  7.8 17 34 0.96
statistically significant (P = 0.80). No complication 25.0  8.4 17 48
Of 148 patients (459 plates) who under- SD, standard deviation.
went Le Fort I, 39 (26.4%, 39/148) had
131 plates (28.5%, 131/459) removed Table 3. Reasons for plate removal and number of patients with plates removed.
from the maxilla. Of 56 patients (123 Reasons for plate removal Total
plates) who underwent BSSO, 36
(64.3%, 36/56) had 81 plates (65.9%, No complication 47
81/123 plates) removed from the mandi- Patient request 47 (66.2%)
ble. Of 123 patients (135 plates) undergo- Complication 24 Maxilla Mandible Chin
ing genioplasty, 19 (15.4%, 19/123) had Infection 14 (19.7%) 8 2 4
24 plates (17.8%, 24/135) removed from Exposed plate 7 (9.9%) 6 1 0
the chin. Screw loose 2 (2.8%) 1 0 1
Plate breakage 1 (1.4%) 0 1 0

Sex distribution
without complications was 24.9  10.1 because of an infectious episode related to
When examining plate removal by sex, years; there was no significant difference the plates. Seven patients (9.9%) had
three male and 12 female patients had in age according to plate removal in the plates removed due to an exposed plate,
plate removal from the maxilla due to presence or absence of complications in two (2.8%) had plates removed because of
complications, compared with 11 male the maxilla. For the mandible, the average an inflammatory reaction caused by a
and 16 female patients who had no com- age of patients having plates removed was loose screw, and one patient had plates
plications. For the mandible, two male and 36.5  10.1 years for those with compli- removed due to plate breakage (Table 3).
two female patients had removals for com- cations compared to 26.4  9.0 years for On evaluation of the surgical site, 16
plications, compared with eight male and those without complications; this differ- plates (12.2% of 131 plates removed) were
25 female patients with uncomplicated ence was statistically significant removed from the maxilla of 15 patients
removals. For the chin, one male and four (P = 0.048). For the chin, the average with complications (35.7% of 42 patients
female patients had removals for compli- age of the patients undergoing plate re- who underwent plate removal) after Le
cations, compared with five male and 12 moval was 25.2  7.8 years for those with Fort I; four plates (4.9% of 81 plates
female patients with uncomplicated complications compared to 25.0  8.4 removed) were removed from the mandi-
removals. There was no significant differ- years for those without complications; ble of four patients with complications
ence between the sexes with regard to there was no significant difference in (10.8% of 37 patients who underwent
plate removal according to the presence age between patients with or without com- plate removal) after BSSO; and six plates
or absence of complications (Table 1). plications in the chin (Table 2). (25.0% of 24 plates removed) were re-
moved from the chin of five patients with
complications (22.7% of 22 patients who
Age distribution Reasons for plate removal
underwent plate removal) after genio-
The average age (mean  standard devia- Plate removal at the patient’s request de- plasty (Table 3).
tion) of the patients was examined accord- spite the absence of complications oc-
ing to the surgical site. For patients curred in a total of 47 of the 71 patients
Time to plate removal
undergoing plate removal in the maxilla, who had plates removed (66.2%). In
the average age of those with complica- patients with plate removal due to com- The mean time to plate removal was
tions was 25.5  8.0 years and of those plications, 14 (19.7%) had plates removed 2243.7  1978.9 days in those with

Please cite this article in press as: Sukegawa S, et al. Is the removal of osteosynthesis plates after orthognathic surgery necessary?
Retrospective long-term follow-up study, Int J Oral Maxillofac Surg (2018), https://doi.org/10.1016/j.ijom.2018.07.001
YIJOM-3983; No of Pages 6

4 Sukegawa et al.

Fig. 1. Time to plate removal.

complications and 616.0  883.6 days in such as infection11–13. In this study, 71 of complications in this study, accounting
those without complications. No plates 240 patients (29.6%) had plates removed, for 19.7%; this is in agreement with other
were removed earlier than when bony and in 10.0% (24/240) this was due to authors who have found infection to be the
healing is generally assumed to be well infection or other complications. Con- main cause of plate removal21–23.
advanced (approximately 9 weeks, or 63 versely, plates were removed at the Interestingly, in this study, complica-
days). patient’s request in 19.6% (47/240) of tions requiring plate removal such as plate
The 71 patients underwent surgery at 94 cases despite there being no complica- exposure and local infection occurred in
sites (39 maxilla, 36 mandible, 19 chin). tions. an evident biphasic manner: within 1 year
Forty patients (56.3%) had plate removal Past clinical research has not supported after the operation and at 5 years after
within a year, of whom 10 had complica- differences in plate removal rate accord- the operation. Current evidence suggests
tions (10 sites; 5 maxilla, 3 mandible, 2 ing to sex5,18. However, some reports have that a foreign body such as an osteosynth-
chin) and 30 did not (41 sites; 14 maxilla, shown that being female is the second esis fixation device may act as a site for
21 mandible, 6 chin). Fourteen patients most significant risk factor for plate re- blood-borne bacterial growth15. Dobbins
(19.7%) had plate removal after 1–5 years, moval and that females significantly more et al.24 reported that there is some evi-
but none had complications (26 sites; 9 often require removal than males16,19. In dence that plates can become colonized by
maxilla, 11 mandible, 6 chin). Ten patients the present study, the difference in remov- blood-borne bacteria, which may increase
(14.1%) had plate removal after 5–10 al rate between females and males was not the prevalence of infection-associated
years, of whom seven had complications statistically significant. symptoms; this may be the cause of plate
(7 sites; 3 maxilla, 1 mandible, 3 chin) and The causal relationship between age infection within 1 year. Meanwhile, there
three did not (3 sites; 1 maxilla, 2 chin). and plate removal due to complications were cases in which plate removal was
Seven patients (9.9%) had plate removal is controversial. Some studies have found necessary due to complications arising at
after 10 years, all of whom had plate no significant correlation between age and 5 years after the operation despite there
removal due to complications (7 maxilla) the risk of plate removal5,18, while others being no problems in the intervening years
(Fig. 1). have indicated a causal relationship with after surgery. Orthognathic surgery is gen-
age11. Manor et al.19 reported that age is a erally performed when the patient is in
statistically significant linear risk factor their late teens to 20s5, and treatment is
Discussion
for plate removal among patients who completed a few years after surgical cor-
Titanium plate fixation is renowned for its have undergone orthognathic surgery. rection. While undergoing treatment and
strength and biocompatibility and is now Peacock et al.20 completed a retrospective management, there are no problems, but
standard practice in many maxillofacial cohort study of patients who underwent increasing age and the change in oral
procedures, including the management orthognathic surgery at a single institu- environment lead to the risk of problems
of craniomaxillofacial fractures and in tion. Subjects aged 40 years at the time due to dental infection25. This study is
orthognathic surgery. However, the use of surgery required hardware removal important in reporting the relevance of
of titanium in a non-sterile field and expo- 23% of the time, whereas those aged the time course after surgery and the need
sure to forces related to normal oral and <40 years required hardware removal on- for plate removal due to complications.
maxillofacial function carry the risk of ly 11% of the time. The present study Plates were removed from 29.6% (71/
complications, such as plate infection or showed that age was a risk factor for 240) of the dentofacial deformity patients
failure, and complications require removal requiring plate removal due to complica- who underwent orthognathic surgery.
of the osteosynthesis plate. In past studies, tions. In particular, for plate removal in the Among these, 33.8% underwent removal
plate removal after orthognathic surgery mandible, the average age of the patients due to complications. The point in favour
has varied between 1.0% and 55% of without complications was 26.4 years and of routine plate removal is that once the
patients11–18. with complications was 36.5 years, and osteosynthesis plate has accomplished its
Although there are some reports of very older patients were significantly more particular purpose, it becomes a useless
high plate removal rates, these high rates likely to require plate removal due to foreign body with the potential to cause
have been based on regular plate removal complications than younger patients. problems, thus routine plate removal may
or patient request. Plate removal is neces- Superficial local infection was the prin- be considered to prevent complica-
sary in many cases due to complications cipal reason for plate removal due to tions21,26. Furthermore, there are cases

Please cite this article in press as: Sukegawa S, et al. Is the removal of osteosynthesis plates after orthognathic surgery necessary?
Retrospective long-term follow-up study, Int J Oral Maxillofac Surg (2018), https://doi.org/10.1016/j.ijom.2018.07.001
YIJOM-3983; No of Pages 6

Osteosynthesis plate removal after surgery 5

where it is necessary to remove the plate iature screwed plates via a buccal approach. J Oral Pathol Oral Radiol Endod
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Competing interests. The authors declare cortical screws. J Oral Maxillofac Surg 27. Sukegawa S, Kanno T, Manabe Y, Matsu-
2006;64:659–68. moto K, Sukegawa-Takahashi Y, Masui M,
that they have no competing interests.
13. Kuhlefelt M, Laine P, Suominen-Taipale L, Furuki Y. Biomechanical loading evaluation
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Please cite this article in press as: Sukegawa S, et al. Is the removal of osteosynthesis plates after orthognathic surgery necessary?
Retrospective long-term follow-up study, Int J Oral Maxillofac Surg (2018), https://doi.org/10.1016/j.ijom.2018.07.001
YIJOM-3983; No of Pages 6

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Please cite this article in press as: Sukegawa S, et al. Is the removal of osteosynthesis plates after orthognathic surgery necessary?
Retrospective long-term follow-up study, Int J Oral Maxillofac Surg (2018), https://doi.org/10.1016/j.ijom.2018.07.001

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