Objective: The favorable properties of silicon nitride (Si3N4) ceramics, such as high mean strength level and fracture toughness, suggest biomedical use as an implant material. Minor reservations about the biocompatibility of Si3N4 ceramics were cleared up by previous in vitro and in vivo investigations.
Study design and setting: A Si3N4 prototype minifixation system was manufactured and implanted for osteosynthesis of artificial frontal bone defects in 3 minipigs. After 3 months, histological sections, computed tomography (CT) scans, and magnetic resonance imaging (MRI) scans were obtained. Finite element modeling (FEM) was used to simulate stresses and strains on Si3N4 miniplates and screws to calculate survival probabilities.
Results: Si3N4 miniplates and screws showed satisfying intraoperative workability. There was no implant loss, displacement, or fracture. Bone healing was complete in all animals. The formation of new bone was observed in direct contact to the implants. The implants showed no artifacts on CT and MRI scanning. FEM simulation confirmed the mechanical reliability of the screws, whereas simulated plate geometries regarding pullout forces at maximum load showed limited safety in a bending situation.
Conclusions: Si3N4 ceramics show a good biocompatibility outcome both in vitro and in vivo. In ENT surgery, this ceramic may serve as a biomaterial for osteosynthesis (eg, of the midface including reconstruction the floor of the orbit and the skull base). To our knowledge, this is the first introduction of a ceramic-based miniplate-osteofixation system. Advantages compared with titanium are no risk of implantation to bone with mucosal attachment, no need for explantation, and no interference with radiologic imaging. Disadvantages include the impossibility of individual bending of the miniplates.