Clinical evaluation of rapid 3D print-formed implants for surgical reconstruction of large cranial defects.

Abstract

To clinically evaluate 3D print-formed implant process, using cranioplasty as a proof of concept, to examine its effectiveness and utility as a method of intraoperative implant fabrication. Twelve patients had a 3D print-formed template created for patient-specific implant manufacture. Of these patients, 10 received intraoperatively formed polymethylmethacrylate cranioplasty implants between 2013 and 2019. The 3D print-formed implant templates produced to manufacture these patient-specific implants were generated using patient computed tomography scans and 3D printed using fused deposition modelling technology. Cosmetic and functional results were determined by participating surgeons, in conjunction with a patient questionnaire. The functional results and stability of the implants were deemed to be favourable by participating surgeons. Three of the 10 patients completed a post-cranioplasty survey, all of whom judged their cosmetic results as good or excellent. At time of writing, the rate of surgical revision was zero and without clinically adverse outcomes. 3D print-formed implants are an effective method of patient-specific implant formation.