A retrospective study to ascertain the need for hardware removal following orthognathic surgery

Pranav Parashar; Sunil Kumar Gulia; Sharwan Kumar Singh; Heeralal Chokotiya; Bhushan Thoke; Rahul V.C. Tiwari

doi:10.4103/SDJ.SDJ_49_20

ORIGINAL ARTICLE

Year : 2021 | Volume : 5 | Issue : 1 | Page : 24-27

A retrospective study to ascertain the need for hardware removal following orthognathic surgery

Pranav Parashar¹, Sunil Kumar Gulia², Sharwan Kumar Singh³, Heeralal Chokotiya⁴, Bhushan Thoke¹, Rahul V.C. Tiwari⁵
¹ Department of Dentistry, NSCB Government Medical College, Jabalpur, Madhya Pradesh, India
² Department of Oral and Maxillofacial Surgery, SGT University, Gurugram, Haryana, India
³ Department of Oral and Maxillofacial Surgery, Chandra Dental College and Hospital, Barabanki, Uttar Pradesh, India
⁴ Senior Resident, Department of Dentistry, NSCB Medical College, Jabalpur, Madhya Pradesh, India
⁵ Department of Oral and Maxillofacial Surgery, Narsinbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar, Gujarat, India

Date of Submission	24-Sep-2020
Date of Acceptance	16-Jan-2021
Date of Web Publication	16-Feb-2021

Correspondence Address:
Pranav Parashar
Professor & HOD, Department of Dentistry, N.S.C.B Government Medical College, Jabalpur, Madhya Pradesh
India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/SDJ.SDJ_49_20

Abstract

Background: The concept of rigid fixation following surgical interventions in the maxillofacial region is in use since the 1970s. The presence of oral native bacteria in addition to the occlusal forces acting on the plates during mastication results in few complications following rigid fixation which would eventually lead to their retrieval. Objective: The purpose of this study was to evaluate the need for hardware removal in the postoperative phase following orthognathic surgery. Methods: This retrospective study encompassed 86 patients who underwent orthognathic surgery for the correction of their dentofacial deformities in a single hospital unit between July 2009 and October 2019. A total of 314 stainless steel miniplates were used for achieving osteosynthesis in 86 patients. The primary outcome variable in this study was hardware removal. Secondary outcome variables included the reason for hardware removal and the duration between the time of placement of the hardware and its removal. The verdict on whether to postoperatively retrieve plates was based on plate exposure, infection, and patient discomfort caused by the palpability of the plate. Results: Out of the 86 patients (314 plates), 36 patients underwent Le Fort I osteotomy, harboring 144 plates; eight patients underwent anterior maxillary osteotomy, harboring 16 plates; 47 patients underwent bilateral sagittal split osteotomy, harboring 94 plates; and 30 patients underwent genioplasty, harboring 60 plates. It was observed that hardware was retrieved from 24 patients (27.90%) only due to palpability. Among the patients from whom the hardware was removed as a result of complications, 41 patients (47.67%) developed an infection in the postoperative phase, 15 patients (17.44%) had exposed hardware, and six patients (6.97%) developed an inflammatory reaction as a result of a loose screw that necessitated the removal of the hardware. Conclusion: Based on the results of this study, it can be concluded that hardware removal is essential following orthognathic surgery in the late postoperative phase. Hence, following confirmation of optimal postoperative osseous healing, patients should be educated about the need for hardware retrieval and the significance of postoperative follow-up.

Keywords: Hardware, orthognathic surgery, rigid fixation

How to cite this article:
Parashar P, Gulia SK, Singh SK, Chokotiya H, Thoke B, Tiwari RV. A retrospective study to ascertain the need for hardware removal following orthognathic surgery. Sci Dent J 2021;5:24-7

How to cite this URL:
Parashar P, Gulia SK, Singh SK, Chokotiya H, Thoke B, Tiwari RV. A retrospective study to ascertain the need for hardware removal following orthognathic surgery. Sci Dent J [serial online] 2021 [cited 2023 Mar 20];5:24-7. Available from: https://www.scidentj.com/text.asp?2021/5/1/24/309547

Background

The literature on dentofacial deformities reveals that some patients exhibit a distinct pattern of dentofacial deformity for which growth modification and camouflage are insufficient and only surgical intervention can offer a possible solution.^[1] It is well-known that the concept of rigid fixation was familiarized in oral surgery during the 1970s.^[2] Vitallium and stainless steel were originally used to make the hardware, followed by titanium and its alloys.^[3] Although titanium is biocompatible, the placement of titanium miniplates into an anatomical area surrounded by oral native bacteria in addition to the occlusal forces acting on the plates during mastication suggest that the placement of titanium plates could be associated with complications.^[4] The previous literature reveals the prime reasons for retrieval of the hardware used for osteosynthesis to be infection and hardware exposure.^[5] We intended to evaluate the causes and the timeframe required for hardware removal following orthognathic surgery.

Materials and Methods

This retrospective study was designed based on records of patients between 18 and 30 years old diagnosed with skeletal malocclusion who were operated on in a single unit by three senior consultants between July 2009 and October 2019. Those patients who underwent surgical interventions in the form of Le Fort I osteotomy, mandibular advancement, and/or genioplasty using titanium miniplates for osteosynthesis were included. Only those patient records in which surgical interventions were performed through a similar operative technique and followed an identical postoperative protocol for the retrieval of hardware were included. Patients with a history of undergoing previous surgical interventions for the correction of dentofacial, syndromic, or posttraumatic deformities and patients who underwent surgical intervention in other units and reported for retrieval of hardware were excluded from the study. Medically compromised patients were also excluded from the study.

The primary outcome variable in this study was hardware removal. Secondary outcome variables included the reason for hardware removal and the duration between the time of placement of the hardware and its removal. Institutional Ethics Committee approval (Regd No.: 056/NSCB/RB-E/2019) was granted, and written informed consent was obtained from all patients. All the patients included in this study underwent either Le Fort I osteotomy, mandibular advancement, and/or genioplasty using titanium miniplates for osteosynthesis.

Patients were discharged from the hospital once they were stable and followed by clinical checkup radiological checkup at regular intervals after the 1^st week and at 6, 12, and 18 months postoperatively. Following this, they were evaluated clinically once every year. To be included in this study, at least 6 months of postoperative follow-up were essential. The verdict on whether to postoperatively retrieve plates was based on plate exposure, infection, and patient discomfort caused by the palpability of the plate. In addition, the experience of the surgeon was used to assess whether the hardware was loose.

Statistical analysis

The information obtained was entered into a database using Microsoft Excel (Microsoft Inc., Redmond, WA, (USA). The information was moved to JMP version 11.2 for Mac (SAS Institute Inc., Cary, NC, USA) for statistical analysis. For statistical significance, a P < 0.05 was determined.

Results

This study comprised 352 patients who underwent orthognathic surgery from July 2010 to October 2019, but only 86 patients fell under the inclusion criteria. Of these, 33 were male and 53 were female, as shown in [Figure 1]. They belonged to the age group of 18–30 years, with a mean age of 24.3 years. For the 86 patients, who were included in this study, 314 miniplates were used for osteosynthesis. No significant difference was noted between the sexes (P = 0.65). Out of the 86 patients (314 plates), 36 patients underwent Le Fort I osteotomy, harboring 144 plates; 8 patients underwent anterior maxillary osteotomy, harboring 16 plates; 47 patients underwent bilateral sagittal split osteotomy, harboring 94 plates; and 30 patients underwent genioplasty, harboring 60 plates, as shown in [Figure 2].

Figure 1: Graph showing the relationship between hardware removal and sex

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Figure 2: Graph showing hardware removal following various surgical interventions

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It can be observed that the hardware was retrieved from 24 patients (27.90%) due to palpability, and there were no other associated complications. Among the patients whose hardware was removed as a result of complications, 41 patients (47.67%) underwent hardware removal due to infection, 15 patients (17.44%) underwent hardware removal due to exposed hardware, and six patients (6.97%) underwent hardware removal due to an inflammatory reaction as a result of a loose screw, as shown in [Figure 3].

Figure 3: Graph showing the reasons for hardware removal

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The mean postoperative duration for hardware removal in patients with complications was 1874 days, while the mean postoperative duration for hardware removal in patients without complications was 412 days, as shown in [Figure 4]. None of the patients underwent hardware removal during the osseous healing phase.

Figure 4: Graph showing the mean postoperative duration for hardware removal

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Discussion

Titanium is well known for its biocompatibility. Titanium miniplates are now being employed more often than conventional stainless steel miniplates for osteosynthesis in treating maxillofacial trauma and othognathics.^[4] The use of titanium miniplates in the oral cavity where there are native bacteria, coupled with exposure to masticatory forces during functioning, is considered to create the risk of complications in the form of hardware failure, necessitating the retrieval of the hardware. The literature reveals that the incidence of hardware removal following orthognathic surgery ranges between 1% and 55%.^[6],[7],[8]

A recent study revealed that 29.6% of the patients who underwent orthognathic surgery required hardware removal in the postoperative phase; among these, only 10% of patients had complications, while the remaining 19.6% of patients chose to get the hardware removed on their own accord.^[4] Another recent study reported that 45% of the patients required hardware removal within 1 year of placement in the maxillofacial region due to infections.^[9]

Previous studies have shown that females are at a greater risk for hardware removal than males.^[8],[10] The results of this study are in accordance with those studies. However, few studies contradict these differences in hardware removal rates based on sex.^[5],[7] Previous studies have also suggested that age is another risk factor for hardware removal and that as age increases, the risk of hardware removal increases.^[10],[11] However, other studies have contradicted this and stated that there is no substantial association between the age of the patient and the risk of hardware removal.^[5],[7] This study did not reveal any relationship between age and the risk of hardware removal, for all the patients included in this study belonged to the same decade of life.

Local infection was the main cause of hardware removal in this study. This is in accordance with previous studies that reported infection to be the primary reason for hardware removal.^[12],[13] Contemporary evidence proposes that a foreign body in the form of hardware could be a region where blood-borne bacterial growth occurs.^[14] Another study stated that blood-borne bacteria colonize the hardware, which subsequently escalates the chances for infection, necessitating hardware removal within 1 year of placement.^[15] For the time being, there are clinical scenarios where hardware retrieval is required as a result of complications after 5 years of surgery regardless of whether there are issues in the years following the surgical intervention.^[4]

Some studies in the past have emphasized that the moment the purpose of the osteosynthesis device is fulfilled, it needs to be considered as an unserviceable foreign body with the potential to cause unwanted complications; in such situations, retrieval of the hardware should be deliberated to prevent complications, since a long-term follow-up may not be feasible.^{[15],[16],[17]} For this reason, considering the evidence from the literature in addition to the results obtained from this study, it is suggested that, following confirmation of optimal postoperative osseous healing, patients should be educated about the need for hardware retrieval and the significance of postoperative follow-up. The debate over whether osteosynthesis devices should be removed or retained remains controversial and can be resolved only with time.

Conclusion

The proportion of patients observed in our study that required hardware removal due to complications in the postoperative period is favorable in comparison with the existing literature. Hence, the authors would like to suggest that, following confirmation of optimal postoperative osseous healing, patients should be educated about the need for hardware retrieval and the significance of postoperative follow-up.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1.	Uppada UK, Sinha R, Reddy DS, Paul D. Soft tissue changes and its stability as a sequlae to mandibular advancement. Ann Maxillofac Surg 2014;4:132-7. [Full text]
2.	Champy M, Lodde JP, Schmitt R, Jaeger JH, Muster D. Mandibular osteosynthesis by miniature screwed plate via a buccal approach. J Maxillofac Surg 1978;6:14-21.
3.	Posnick JC, Choi E, Chavda A. Method of osteotomy fixation and need for removal following bimaxillary orthognathic, osseous genioplasty, and intranasal surgery: A retrospective cohort study. Int J Oral Maxillofac Surg 2017;46:1276-83.
4.	Sukegawa S, Kanno T, Manabe Y, Matsumoto K, Sukegawa-Takahashi Y, Masui M, et al. Is the removal of osteosynthesis plates after orthognathic surgery necessary? Retrospective long-term follow-up study. Int J Oral Maxillofac Surg 2018;47:1581-6.
5.	Little M, Langford RJ, Bhanji A, Farr D. Plate removal following orthognathic surgery. J Craniomaxillofac Surg 2015;43:1705-9.
6.	Kuhlefelt M, Laine P, Suominen-Taipale L, Ingman T, Lindqvist C, Thorén H. Risk factors contributing to symptomatic miniplate removal: A retrospective study of 153 bilateral sagittal split osteotomy patients. Int J Oral Maxillofac Surg 2010;39:430-5.
7.	Widar F, Afshari M, Rasmusson L, Dahlin C, Kashani H. Incidence and risk factors predisposing plate removal following orthognathic surgery. Oral Surg Oral Med Oral Pathol Oral Radiol 2017;124:231-9.
8.	Falter B, Schepers S, Vrielinck L, Lambrichts I, Politis C. Plate removal following orthognathic surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2011;112:737-43.
9.	Khandelwal P, Rai AB, Bulgannawar B, Vakaria N, Sejani H, Hajira N. Miniplate removal in operated cases of maxillofacial region in a dental institute in Rajasthan, India. Med Pharm Rep 2019;92:393-400.
10.	Manor Y, Chaushu G, Taicher S. Risk factors contributing to symptomatic plate removal in orthognathic surgery patients. J Oral Maxillofac Surg 1999;57:679-82.
11.	Peacock ZS, Lee CC, Klein KP, Kaban LB. Orthognathic surgery in patients over 40 years of age: Indications and special considerations. J Oral Maxillofac Surg 2014;72:1995-2004.
12.	Mosbah MR, Oloyede D, Koppel DA, Moos KF, Stenhouse D. Miniplate removal in trauma and orthognathic surgery – A retrospective study. Int J Oral Maxillofac Surg 2003;32:148-51.
13.	Bhatt V, Chhabra P, Dover MS. Removal of miniplates in maxillofacial surgery: A follow-up study. J Oral Maxillofac Surg 2005;63:756-60.
14.	Schmidt BL, Perrott DH, Mahan D, Kearns G. The removal of plates and screws after Le Fort I osteotomy. J Oral Maxillofac Surg 1998;56:184-8.
15.	Dobbins JJ, Seligson D, Raff MJ. Bacterial colonization of orthopedic fixation devices in the absence of clinical infection. J Infect Dis 1988;158:203-5.
16.	Thorén H, Snäll J, Hallermann W, Kormi E, Törnwall J. Policy of routine titanium miniplate removal after maxillofacial trauma. J Oral Maxillofac Surg 2008;66:1901-4.
17.	Alpert B, Seligson D. Removal of asymptomatic bone plates used for orthognathic surgery and facial fractures. J Oral Maxillofac Surg 1996;54:618-21.