Prototype of a silicon nitride ceramic-based miniplate osteofixation system for the midface.

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.

In vitro behavior of a porous TiO2/perlite composite and its surface modification with fibronectin.

In this study, we introduce a porous composite material, termed "Ecopore", and describe in vitro investigation of the material and its modification with fibronectin. The material is a sintered compound of rutile TiO2 and the volcanic silicate perlite with a macrostructure of interconnecting pores. It is both inexpensive and easy to manufacture. We first investigated Ecopore for corrosion and leaching of elements in physiological saline. The corrosion supernatants did not contain critical concentrations of toxic trace elements. In an in vitro model, human primary osteoblasts (HOB) were cultured directly on Ecopore. HOB grew on the composite as well as on samples of its single constituents, TiO2 and perlite glass, and remained vital, but cellular spreading was less than on tissue culture plastic. The pro-inflammatory cytokines IL-1 and TNF-alpha were below detection limits in HOB culture supernatants, whereas IL-6 was detectable on a low level. To enhance cellular attachment and growth, the surface of the composite was modified by etching, functionalization with aminosilane and coupling of fibronectin. This modification greatly enhanced the spreading of HOB, indicated by vital staining and Sodium 3'-[1-(phenylaminocarbonyl)-3,4-tetrazolium]-bis (4-methoxy-6-nitro) benzene sulfonic acid hydrate (XTT) metabolism assays. HOB grew on the entire visible surface of porous fibronectin-modified composite, expressing alkaline phosphatase, a mature osteoblast marker. We conclude that Ecopore is non-toxic and sustains HOB growth, cellular spreading being improvable by coating with fibronectin. The composite may be usable in the field of bone substitution.