Professional Documents
Culture Documents
ScienceDirect
Original Article
a
Department of Plastic Surgery, Chang Gung Memorial Hospital at Chiayi, Taiwan
b
Craniofacial Center, Department of Plastic Surgery, Chang Gung Memorial Hospital at Linkou, Taiwan
c
Division of Trauma Plastic Surgery, Department of Plastic Surgery, Chang Gung Memorial Hospital at
Linkou, Taiwan
d
Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital at Keelung, College
of Medicine, Chang Gung University, Craniofacial Research Center, Taoyuan, Taiwan
Received 22 November 2016; received in revised form 12 March 2017; accepted 15 March 2017
KEYWORDS Summary Background: Zygoma fracture is of clinical importance because malar prominence
Bioabsorbable plate; plays an essential role in facial appearance. Traditionally, most maxillofacial surgeons perform
Titanium plate; osteosynthesis with titanium plates and screws for rigid fixation. However, this procedure has
Comparison; certain disadvantages that include the possibility of implant exposure, palpability or loosening
Zygoma fracture of the screws, painful irritation, temperature sensitization, and radiographic artifacts. In this
study, we compared the function and satisfaction outcome between Bonamates bio-
absorbable implant and Leibinger titanium implant.
Method: Consecutively 53 patients with isolated unilateral zygomatic fracture that were
treated with the Bonamates bioabsorbable plate system, n Z 53 were compared to patients
with the titanium plate system, n Z 55 in the period between 2009 and 2013. All patients were
followed-up at least 6 months. Preoperative and postoperative facial computed tomography
(CT) scans were performed and scored from 0 to 2 in the 5 areas of zygoma. A score of 2 indi-
cated the most severely displaced fracture in one of the areas. A visual analogue scale ranging
from 0 to 10 was used to assess the postoperative aesthetic and functional satisfactions.
Result: The mean ages of the patients in the bioabsorbable and titanium plate groups were 33
years and 30 years, respectively. The male to female ratios were 1.2:1 (bioabsorbable plate
group) and 1.1:1 (titanium plate group). The average preoperative CT scan scores of the bio-
absorbable and titanium plate groups were 5.7 and 5.1, respectively. The postoperative CT
scan scores of the bioabsorbable and titanium plate groups were 1.3 and 1.1, respectively.
* Corresponding author. Department of Plastic and Reconstruction Surgery, Chang Gung Memorial Hospital at Keelung, Chang Gung
University, College of Medicine, Craniofacial Research Center, 222, Maijin Road, Keelung, Taoyuan, Taiwan. Fax: þ886 2 24313161.
E-mail address: ctchenap@cgmh.org.tw (C.-T. Chen).
http://dx.doi.org/10.1016/j.asjsur.2017.03.003
1015-9584/ª 2017 Asian Surgical Association and Taiwan Robotic Surgical Association. Publishing services by Elsevier B.V. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article in press as: Wu C-M, et al., Surgical treatment of isolated zygomatic fracture: Outcome comparison between
titanium plate and bioabsorbable plate, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.03.003
+ MODEL
2 C.-M. Wu et al.
The implant cost of the bioabsorbable group was approximately 6-fold higher than that of the
titanium plate group. The complication rate was similar in both groups and included complica-
tions such as palpable implant, skin irritation, and hypersensitive cheek. The patients in both
groups attained similar mouth-opening function and a satisfactory score at 6 months after
operation.
Conclusion: This study revealed that the bioabsorbable plate outcome was similar to the tita-
nium plate outcome for patients with isolated unilateral zygomatic fracture. The bio-
absorbable implant system provides another option for internal fixation devices in the
treatment of zygomatic fractures and avoids implant removal surgery; however, the implant
cost of bioabsorbable plates is higher than that of titanium plates in Taiwan.
ª 2017 Asian Surgical Association and Taiwan Robotic Surgical Association. Publishing services
by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article in press as: Wu C-M, et al., Surgical treatment of isolated zygomatic fracture: Outcome comparison between
titanium plate and bioabsorbable plate, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.03.003
+ MODEL
Surgical treatment of isolated zygomatic fracture 3
Figure 1 Intraoperative view showing the bioabsorbable plate used to stabilize the fracture sites of the zygomaticomaxillary
buttress.
Table 1 Scoring system for assessment of the degree of fracture displacement and adequacy of reduction.
Score 0 1 2
Preoperative Minimal displacement Moderate displacement Segmental or comminuted displacement
Postoperative Adequate reduction and union Mild displacement and nonunion Inadequate reduction
The postoperative clinical assessments were performed bioabsorbable plate group. By contrast, 22% diplopia and
regularly at 4, 12, and 24 weeks to evaluate patient satis- 18% enophthalmos were observed in the titanium plate
faction, using the visual analogue scale and functional group.
outcome. A 10-cm line with both ends labeled as extremes The average preoperative CT scan scores of the bio-
and a score of 10 indicates high satisfaction. The patients absorbable plate group were 5.5 (36% of patients), 5.9
marked an X at the point that represents their satisfaction (60%), and 5.1 (4%) for the one, two, and three points fix-
most appropriately. ations, respectively. By contrast, the average preoperative
The outcome of preoperative and postoperative score CT scan scores of the titanium plate group were 4.5 (35%),
and satisfactory score between two plate groups are 5.4 (62%) and 4.2 (2%) for the one, two and three points
compared using the two-sample t-test for unpaired com- fixations respectively. The average preoperative CT scan
parisons. For each test, a p value < 0.05 is considered score in the bioabsorbable plate group was 5.7 and
statistically significant. improved to 1.3 postoperative with an improvement degree
of 4.3 (Figs. 2 and 3). In the titanium plate group, the
average preoperative CT scan score was 5.1 and improved
3. Results to 1.1 postoperative with an improvement degree of 4. The
average operation time for the bioabsorbable plate group
Both the bioabsorbable and titanium plate groups included was 40 min longer than that for the titanium plate group. In
patients (n Z 53, 55) with a follow-up at least 6 months. addition, the average implant cost of the bioabsorbable
The mean of patient age in the bioabsorbable and titanium plate group was 5.52-fold higher than that of the titanium
plate groups were 33 years and 30 years, respectively. The plate group (Table 2).
male-to-female ratios were 1.2:1 and 1.1:1 in the bio- The complications included palpable implant, hyper-
absorbable and titanium plate groups, respectively. Co- sensitive cheek, skin irritation, and ectropion. The
morbidity, associated injury, and trauma mechanisms complication rate was similar in both groups. The maximal
were comparable between the groups. In both groups, the mouth-opening function was higher in the bioabsorbable
initial symptoms included malar depression with numbness plate group in the first 3 postoperative months, but a
in the territory of the infraorbital nerve in all patients. In similar function was observed in both groups in the first 6
addition, 6% diplopia and 4% enophthalmos (1 mm postoperative months (Fig. 4). The appearance satisfaction
difference than normal eye) were observed in the
Please cite this article in press as: Wu C-M, et al., Surgical treatment of isolated zygomatic fracture: Outcome comparison between
titanium plate and bioabsorbable plate, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.03.003
+ MODEL
4 C.-M. Wu et al.
Figure 2 A Preoperative 3-dimensional computed tomographic scan showing the left zygomatic complex fracture with severe
displacement over the inferior orbital rim and lateral buttress fracture. Figure 2B Postoperative CT scan at 6 months revealing the
bioabsorbable plate located at the inferior orbital rim and lateral buttress.
Figure 3 A Preoperative 3-dimensional CT scan showing the moderate displacement of the left zygoma complex. Figure 3B
Postoperative 3-dimensional CT scan at 23 months postoperation showing the adequate reduction of left zygoma with the bio-
absorbable plate fixed at the lateral buttress.
was assessed in both groups at 1, 3, and 6 months post- The other type of bioabsorbable plate is copolymer,
operation (Fig. 5). No case in either group required a sec- which includes the following: (1) Lactosorb, comprising
ondary procedure for removing the implant during the PLLA/PGA (82/18) with crystallinity of <10%, which retains
follow-up period of 6 months. 70% of initial strength for 6e8 weeks and dissolves
completely after 12e15 months, (2) BioSorb, comprising
PLLA/P (L/DL) LA (70/30), and (3) DeltaSystem, comprising
4. Discussion
PLLA/PGA/PDLA (85/10/5). Previous studies have reported
satisfactory results of fixing zygomatic fractures with bio-
In general, 2 types of bioabsorbable plate are available on
absorbable plates and screws.14e17
the market; one is homopolymer, including PLLA and PGA.
A randomized study was conducted by Wittwer et al18 to
PLLA was the first bioabsorbable material applied in
compare the treatment outcomes and complication rates in
treating facial trauma, which was used in the treatment of
patients with displaced zygomatic fractures. The patients
patients with zygomatic fracture by Rudolf in 1987. PGA has
were divided, on the basis of the fixation material, into 4
more rapid hydrolysis and triggers higher inflammatory re-
groups (A: LactoSorb, total number of patients (n) Z 15; B:
action.13 The disadvantages of homopolymer include unfa-
BioSorb, n Z 17; C: DeltaSystem, n Z 17; and D: Titanium,
vorable degradation, foreign body reaction, prominent
n Z 15), whereas patients with comminuted zygomatic
swelling irrespective of the implant location, and the
fractures were excluded. No difference was observed in the
requirement of surgical removal.14 Therefore, pure PLLA
handling characteristics of the 3 materials (LactoSorb
and PGA are no longer used.
Please cite this article in press as: Wu C-M, et al., Surgical treatment of isolated zygomatic fracture: Outcome comparison between
titanium plate and bioabsorbable plate, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.03.003
+ MODEL
Surgical treatment of isolated zygomatic fracture 5
1.5 mm, BioSorb FX 1.5 mm, and DeltaSystem 1.7 mm). No In a study conducted by Enislidis et al, 65 patients with
significant differences among all the bioabsorbable osteo- isolated unilateral zygomatic fracture fixed with Lactosorb
synthesis materials or between bioabsorbable and titanium plates and screws were included. Thirty patients received
fixation materials were observed with respect to fracture the first fixation point at the zygomaticomaxillary buttress.
healing and postoperative complications.18 All patients showed a high postoperative symmetry (65/65).
Please cite this article in press as: Wu C-M, et al., Surgical treatment of isolated zygomatic fracture: Outcome comparison between
titanium plate and bioabsorbable plate, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.03.003
+ MODEL
6 C.-M. Wu et al.
The short-term complication rate was 22.8% and included both types are covered by Taiwan’s National Health Insur-
complications such as intraoral dehiscence with or without ance program. Furthermore, the bioabsorbable plate group
implant exposure, temporary swelling, and ectropion. Five had a similar functional outcome and patient satisfaction
patients had a long-term complication of ectropion, rate as the titanium plate group. The advantage of the
whereas no implant-related complications were observed in bioabsorbable plate is that it can avoid a secondary surgical
the long-term follow-up period. Thus, the authors reported procedure for plate removal if necessary in comparison
that bioabsorbable osteosynthesis materials can be with 12% of hardware removal in Francel’s study.4
considered additional tools, but not for the replacement of
conventional metal osteosynthesis materials.19
The complications in using the bioabsorbable plate re- 5. Conclusion
ported in previous studies have included infection, fracture
instability, relapse, and implant-related tissue reaction,16 Both the bioabsorbable and titanium plate groups had
which was the most common complication causing recur- similar outcomes without major complications. The
rent pain and erythema of the overlying skin.18 In our study, Bonamates plate provides reliable results for isolated,
we used Bonamates (BonaPlates, PD series, Bonamates, non-comminuted zygomatic fractures in selective cases and
BioTech One, Taipei, Taiwan) in the bioabsorbable plate presents another optional fixation device for zygomatic
system. The molecular ratio of Bonamates was PLLA: fracture. However, a longer follow-up period is required to
PDLA Z 95:5. The L-Lactide can provide strength to implants observe possible long-term complications.
and degrades slowly because of hydrophobicity. The D-Lac-
tide can disrupt crystallinity and has more flexibility. In our
study, we observed 2 cases of skin irritation on cheeks and Conflict of interest
one case of palpable plate at the ZeF junction. The overall
complication rate observed in our study was 15%, which was There are no commercial associations or conflicts of inter-
lower than that observed in a previous study (22.8%).19 est for disclosure by the authors.
However, a long-term follow-up period is required to
investigate the probability of the local tissue inflammation
or implant exposure caused by a new biodegradable plate. References
The other disadvantage of bioabsorbable implants is
incomplete screw insertion because of inadequate screw 1. Reynolds JR. Late complications vs. method of treatment in a
tapping and screw breakage; thus, an experienced surgeon large series of mid-facial fractures. Plast Reconstr Surg. 1978;
is required for handling bioabsorbable screws. No screw 61:871e875.
breakage was observed during the operations in our study. 2. O’Hara DE, Del Vecchio DA, Bartlett SP, et al. The role of
In addition, the mean operation time was 136 min longer in microfixation in malar fractures: a quantitative biophysical
the bioabsorbable plate group than in the titanium plate study. Plast Reconstr Surg. 1996;97:345e350.
group. Furthermore, this explained that the intraoperative 3. Rinehart GC, Marsh JL, Hemmer KM, et al. Internal fixation of
handling procedure involved a learning curve for both the malar fractures: an experimental biophysical study. Plast
Reconstr Surg. 1989;84:21e25.
surgeons and scrubbing nurses.10 We supposed that the
4. Francel TJ, Birely BC, Manson PN, et al. The fate of plates and
operation time could be reduced as the staff gains screws after facial fracture reconstruction. Plastic Reconstr
experience. Surg. 1992;90:568e573.
A previous study20 used craniofacial anthropometry 5. Christopher E, Gregory E. Evidence-based medicine: zygoma
techniques to describe the position of the orbitozygomatic fractures. Plastic Reconstr Surg. 2013;132:1649e1657.
complex in 3-dimensions and to allow the comparison or 6. Mosbah MR, Oloyede D, Koppel DA, et al. Miniplate removal in
measurement of post-trauma complex displacement. trauma and orthognathic surgeryda retrospective study. Int J
However, the amount of facial swelling should be consid- Oral Maxillofac Surg. 2003;32:148e151.
ered using this measurement tool. Ellis et al used a CT scan 7. Nagase D, Courtemanche D, Peters D. Plate removal in trau-
to quantify the amount of malalignment of the zygomati- matic facial fractures: 13-year practice review. Ann Plast Surg.
2005;55:608e611.
comaxillary complex at only 3 different points to assess its
8. Bhatt V, Chhabra P, Dover MS. Removal of miniplates in
outcome.21 We developed a scoring system based on the CT maxillofacial surgery: a follow-up study. J Oral Maxillofac
scan scores to evaluate the severity of fracture displace- Surg. 2005;63:756e760.
ment and adequacy of fracture reduction in 5 junctional 9. Park S, Kim JH, Kim H, et al. Evaluation of poly(lactic-co-
points. This system provided more objective assessment glycolic acid) plate and screw system for bone fixation. J
and presented the quantitative difference between the Craniofac Surg. 2013;24:1021e1025.
preoperative and postoperative CT scan images. 10. Waris E, Yrjo K, Nureddin A, et al. Bioabsorbable fixation de-
Bioabsorbable devices have limitations such as the bulk vices in trauma and bone surgery: current clinical standing.
and large diameter of bioabsorbable materials and they Expert Rev Med Devices. 2004;1:229e240.
cannot be used under certain conditions, such as poor 11. Hanemann Jr M, Simmons O, Jain S. A comparison of combi-
nations of titanium and resorbable plating systems for repair of
stability of fixation and small bone fragments. Because of
isolated zygomatic fractures in the adult, a quantitative
this limitation Wittwer et al combined the bioabsorbable biomechanical study. Ann Plastic Surg. 2005;54:402e408.
and titanium plates to treat isolated zygomatic complex 12. Singh V, Sharma B, Bhagol A. Evaluating the applicability of a
fractures.18 biodegradable osteosynthesis plating system in the manage-
Although the cost of bioabsorbable plates is much higher ment of zygomatico-maxillary complex fractures. Otolaryngol
than that of traditional titanium plates, the implant cost of Head Neck Surg. 2011;145:924e929.
Please cite this article in press as: Wu C-M, et al., Surgical treatment of isolated zygomatic fracture: Outcome comparison between
titanium plate and bioabsorbable plate, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.03.003
+ MODEL
Surgical treatment of isolated zygomatic fracture 7
13. Bos RRM, Boering G, Leenslag JW, et al. Resorbable poly(L- 18. Wittwer G, Adeyemo WL, Enislidis G, et al. Complications after
lactide) plates and screws for the fixation of zygomatic frac- zygoma fracture fixation: is there a difference between
tures. J Oral Maxillofac Surg. 1987;45:751e753. biodegradable materials and how do they compare with tita-
14. Enislidis G, Pichorner S, Lambert F, et al. Fixation of zygomatic nium osteosynthesis? Oral Surg Oral Med Oral Pathol Oral
fractures with a new biodegradable co- polymer osteosynthesis Radiol Endod. 2006;101:419e425.
system: preliminary results. Int J Oral Maxillofac Surg. 1998; 19. Enislidis G, Lagogiannis G, Ewers R, et al. Fixation of zygomatic
27:352. fractures with a biodegradable copolymer osteosynthesis sys-
15. Triana Jr RJ, Sockley WW. Pediatric zygomaticoorbital complex tem: short and long-term results. Int J Oral Maxillofac Surg.
fracture: the use of resorbable plating systems. A case report. 2005;34:19e26.
J Craniomaxillofac Trauma. 1998;4:32e36. 20. Czerwinski M, Martin M, Lee C. Quantitative topographical
16. Eppley BL, Prevel CD. Non-metallic fixation in traumatic mid- evaluation of the orbitozygomatic complex. Plastic Reconstr
facial fractures. J Craniofac Surg. 1999;8:103e109. Surg. 2005;115:1858e1862.
17. Suuronen R, Haers PE, Lindqvist C, et al. Update on biore- 21. Ellis E, Kittidumkerng W. Analysis of treatment for isolated
sorbable plates in maxillofacial surgery. Facial Plast Surg. zygomaticomaxillary complex fractures. J Oral Maxillofac
1999;15:61e72. Surg. 1996;54:386e400.
Please cite this article in press as: Wu C-M, et al., Surgical treatment of isolated zygomatic fracture: Outcome comparison between
titanium plate and bioabsorbable plate, Asian Journal of Surgery (2017), http://dx.doi.org/10.1016/j.asjsur.2017.03.003