Quality Characteristics and Clinical Relevance of In-House 3D-Printed Customized Polyetheretherketone (PEEK) Implants for Craniofacial Reconstruction

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Abstract
Additive manufacturing (AM) of patient-specific implants (PSIs) is gradually moving towards in-house or point-of-care (POC) manufacturing. Polyetheretherketone (PEEK) has been used in cranioplasty cases as a reliable alternative to other alloplastic materials. As only a few fused filament fabrication (FFF) printers are suitable for in-house manufacturing, the quality characteristics of the implants fabricated by FFF technology are still under investigated. This paper aimed to investigate PEEK PSIs fabricated in-house for craniofacial reconstruction, discussing the key challenges during the FFF printing process. Two exemplary cases of class III (Group 1) and class IV (Group 2) craniofacial defects were selected for the fabrication of PEEK PSIs. Taguchi’s L9 orthogonal array was selected for the following nonthermal printing process parameters, i.e., layer thickness, infill rate, number of shells, and infill pattern, and an assessment of the dimensional accuracy of the fabricated implants was made. The root mean square (RMS) values revealed higher deviations in Group 1 PSIs (0.790 mm) compared to Group 2 PSIs (0.241 mm). Horizontal lines, or the characteristic FFF stair-stepping effect, were more perceptible across the surface of Group 1 PSIs. Although Group 2 PSIs revealed no discoloration, Group 1 PSIs displayed different zones of crystallinity. These results suggest that the dimensional accuracy of PSIs were within the clinically acceptable range; however, attention must be paid towards a requirement of optimum thermal management during the printing process to fabricate implants of uniform crystallinity.

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