Abstract
INTRODUCTION: We fabricated custom-made artificial bones using three-dimensionally layered manufacturing (3D printing) process, and have applied them to patients with facial deformities. We termed this novel artificial bone the "CT-bone". The aim of the present study was to evaluate the middle- and long-term safety and effectiveness of the CT-bones after transplantation. METHODS: The subject areas involved were 23 sites of 20 patients with facial bone deformities due to congenital abnormality, tumor, or trauma. The CT-bones were used for augmentation; they were evaluated by CT images, minimally for 1 year and maximally for 7 years and 3 months (3 years and 1 month on average) after transplantation. RESULTS: No serious systemic events due to the CT-bone graft were found during the observation period (1 year postoperatively). In 4 sites of 4 patients, the CT-bones were removed due to local infection of the surgical wounds at 1-5 years postoperatively. Compatibility of the shapes between the CT-bone and the recipient bone was confirmed to be good during the operation in all of the 20 cases, implying that the CT-bones could be easily installed onto the recipient sites. During the CT evaluation (<7 years and 3 months), no apparent chronological change was seen in the shape of the CT-bones. Sufficient bone union was confirmed in 19 sites. The inner CT values of the CT-bones increased in all the sites. The longer the postoperative period, greater increases in the CT values of the CT-bones tended to be observed. CONCLUSIONS: The CT-bone showed maintenance of the original shape and good bone replacement, based on the middle- and long-term follow-ups. In the future, we would make an intelligent type of artificial bones in which bone regeneration is induced by gradually releasing angiogenesis-inducing factors and/or bone-regeneration-inducing factors at the three-dimensionally controlled positions.