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Highligths • Strategy envisaging a virtual/mock surgery on a CAD/AM model of the patient cranium. • Additive Manufacturing based intervention simulation. • Additive Manufacturing based design of implants. • Complex craniofacial defects corrected using a single-step intervention. Abstract Background and objective The purpose of the present paper is to pave the road to the systematic optimization of complex craniofacial surgical intervention and to validate a design methodology for the virtual surgery and the fabrication of cranium vault custom plates. Recent advances in the field of medical imaging, image processing and additive manufacturing (AM) have led to new insights in several medical applications. The engineered combination of medical actions and 3D processing steps, foster the optimization of the intervention in terms of operative time and number of sessions needed. Complex craniofacial surgical intervention, such as for instance severe hypertelorism accompanied by skull holes, traditionally requires a first surgery to correctly "resize" the patient cranium and a second surgical session to implant a customized 3D printed prosthesis. Between the two surgical interventions, medical imaging needs to be carried out to aid the design the skull plate. Instead, this paper proposes a CAD/AM-based one-in-all design methodology allowing the surgeons to perform, in a single surgical intervention, both skull correction and implantation. Methods A strategy envisaging a virtual/mock surgery on a CAD/AM model of the patient cranium so as to plan the surgery and to design the final shape of the cranium plaque is proposed. The procedure relies on patient imaging, 3D geometry reconstruction of the defective skull, virtual planning and mock surgery to determine the hypothetical anatomic 3D model and, finally, to skull plate design and 3D printing. Results The methodology has been tested on a complex case study. Results demonstrate the feasibility of the proposed approach and a consistent reduction of time and overall cost of the surgery, not to mention the huge benefits on the patient that is subjected to a single surgical operation. Conclusions Despite a number of AM-based methodologies have been proposed for designing cranial implants or to correct orbital hypertelorism, to the best of the authors' knowledge, the present work is the first to simultaneously treat osteotomy and titanium cranium plaque. [ABSTRACT FROM AUTHOR]