Comparison between patient specific implants and conventional mini-plates in Le Fort I osteotomy with regard to infections: No differences in up to 3-year follow-up

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Abstract

Individually designed osteotomies and milled or printed patient-specific osteosynthesis materials are rapidly becoming a standard in maxillofacial reconstructive surgery. The benefits of using patient-specific implants (PSIs) in orthognathic surgery are especially clear in complex cases, and for this reason they are rapidly becoming common practice. We have earlier reported the benefits related to the use of PSIs as reposition and fixation system in Le Fort I osteotomy. The aim of this study was to compare complications associated with fixation with PSIs (31 patients) versus conventional mini-plates (37 patients) in Le Fort I osteotomy. No statistically significant differences in infection, reoperations or soft tissue problems were observed between the two systems used. Interestingly, three of the 37 patients in the mini-plate group underwent reoperation due to insufficient advancement or malocclusion, whereas none of the patients in the PSI group needed reoperation. In conclusion, PSIs are reliable for use in orthognathic surgery, with no signs of infection associated complications.

Introduction

The use of three-dimensional (3D) design and virtual surgery is becoming a common practice in orthognathic surgery. The use of individually manufactured surgical drill and cutting guides as well as patient specific implants (PSI) for osteosynthesis is now available for all clinicians, with reasonable delivery time and expenses. The first 3D-designed implants were mere modifications of conventional mini-plates, but when the computer-aided manufacturing/computer-aided design (CAD/CAM) milling and printing techniques started to develop, more specific and freely designed implants were possible to produce (Gander et al., 2015, Mazzoni et al., 2015, Suojanen et al., 2016, Suojanen et al., 2017). Most of the commercially available systems are using CAD/CAM wafers to produce patient-specific saw and drill guides. Some systems also provide custom-made 3D-printed or milled titanium implants. Individually milled implants combined with the use of drill guides also enables wafer-free positioning of the maxilla. We have earlier demonstrated the reliable use of PSIs for wafer-free repositioning and osteosynthesis in Le Fort I osteotomy (Suojanen et al., 2016). This is supported in a recent publication by Heufelder et al., which indicates a highly accurate postoperative position of the maxilla when using PSIs in Le Fort I osteotomy (Heufelder et al., 2017). On the contrary, this is not often the case with conventional systems (Ellis, 1990). Commonly used PSIs are manufactured either by milling from titanium mono-blocks or by laser sintering from titanium powder. The individually designed implants often follow the contours of the bone with high fidelity, but the implants are rather bulky and their surface is clearly rougher as compared to that of conventional mini-plates. This has raised questions about possible infectious problems. At present, there are no data on differences in the susceptibility to postoperative infections between mini-plates and PSIs.

In our study, 31 patients treated with Le Fort I osteotomy and PSIs were followed up for up to 3 years with regard complications associated with infections. We also collected a retrospective cohort of 37 patients treated with Le Fort I osteotomy and conventional mini-plate fixation for comparison regarding postoperative complications.

Section snippets

Patients and procedures

All the patients treated with PSIs obtained implants manufactured by Planmeca ProModel system (Planmeca Ltd, Helsinki, Finland). The cohort of the PSI patients (n = 31) was formed as described earlier (Suojanen et al., 2016). The follow-up data of the 31 patients treated with PSIs was collected from Helsinki University Hospital patient archives (to February 15, 2017). All patients visited the clinic for postoperative controls according to the clinical protocol, with no follow-up data missing.

Results

The demographic (age and gender) data of the PSI and mini-plate cohorts did not differ statistically (P = 0.304 and 0.557, respectively). The PSI cohort data covered follow-up from 14 to 37 months (average 26 months) and the mini-plate cohort from 38 to 62 months (average 49 months). The individual patient data as well as postoperative wound and soft tissue problems and reoperations can be seen in detail in Table 1 for PSI patients and in Table 2 for the conventional mini-plate patients. The

Discussion

Three-dimensional planning and the use of PSI is an interesting tool for faster and more precise outcomes when advancing the maxilla by Le Fort I osteotomy (Van Hemelen et al., 2015, Heufelder et al., 2017). The first 3D designed and produced osteosynthesis material were merely conventional mini-plates modified on top of stereolithography models. Only a few years ago, when laser sintering and CAD/CAM milling techniques started to develop, were the first true PSIs for orthognathic surgery were

Conclusions

Our present follow-up data suggest that CAD/CAM-produced titanium PSIs do not differ in their local long-term complication profile as compared to conventional mini-plate systems used in Le Fort I osteotomy, with no signs of infection-associated complications. Larger studies are, however, needed for analyzing the further possible beneficial effects of the use of PSIs, including the number of reoperations needed and stability of the outcomes compared to those achieved with the use of conventional

Conflicts of interest

The authors JS, JL and PS have participated in congresses where attendance fees were in part or in total supported by DePuy-Synthes or KLS-Martin.

Acknowledgments

This work is financially supported by Emil Aaltonen Foundation, Finnish-Norwegian Medical Foundation, The Finnish Medical Foundation, Paulo Foundation, Helsinki University Hospital Funds and Academy of Finland (reference no. 299749).

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These authors contributed equally to this work.

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