Potential of FeAlCr intermetallics reinforced with nanoparticles as new biomaterials for medical devices.

Novel FeAlCr oxide dispersion strengthened intermetallics that are processed by powder metallurgy have been developed as potential biomaterials. The alloys exhibit a small grain size and a fine dispersion of yttria provides the material with a high yield strength and depending on the alloy composition good ductility (up to 5%). The biocompatibility of the alloy was assessed in comparison with commercial alumina. Saos-2 osteoblast-like cells were either challenged with mechanically alloyed particles, or seeded onto solid samples. Viability and proliferation of cells were substantially unaffected by the presence of a high concentration of particles (1 mg/mL). Solid samples of novel FeAlCr intermetallic have shown a good biocompatibility in vitro, often approaching the behavior of materials well known for their biological acceptance (e.g. alumina). It has been found that osteoblasts are able to produce ALP, a specific marker of cells with bone-forming activity. In this respect, ALUSI alloys hold the promise to be suitable substrate for bone integration. The finding of no cytotoxic effect in the presence of the alloy particles is a reliable proof of the absence of acute toxicity of the material.

Evaluation of bone healing enhancement by lyophilized bone grafts supplemented with platelet gel: a standardized methodology in patients with tibial osteotomy for genu varus.

Orthopedic practice may be adversely affected by an inadequate bone repair that might compromise the success of surgery. In recent years, new approaches have been sought to improve bone healing by accelerating the rate of new bone formation and the maturation of the matrix. There is currently great interest in procedures involving the use of platelet gel (PG) to improve tissue healing, with satisfactory results both in vitro and in maxillofacial surgery. Otherwise, to our knowledge, only a preliminary clinical study was undertaken in the orthopedic field [Kitoh et al., Bone 2004;35:892-898] and the efficacy of PG is still controversial. Our paper focuses on the effect on bone regeneration by adding PG to lyophilized bone chips used for orthopedic applications. The clinical model and the laboratory methodology were standardized. As a clinical model, we employed the first series of patients of a randomized case-control study undergoing high tibial osteotomy (HTO) for genu varus. Ten subjects were enrolled: in 5 patients lyophilized bone chips supplemented with PG were inserted during tibial osteotomy (group A); 5 patients were used as a control (group B) and lyophilized bone chips without gel were applied. Forty-five days after surgery, computed tomography scan guided biopsies of grafted areas were obtained and the bone maturation was evaluated by a standardized methodology: the osteogenic and angiogenic processes were semi-quantitatively characterized by using histomorphometry, and the mineral component of the lyophilized and host bone was analyzed by using X-ray diffraction technique with sample microfocusing and microradiography. Lyophilized bone with PG seems to accelerate the healing process, as shown by new vessel formation and deposition of newly formed bone, with no evidence of inflammatory cell infiltrate, when compared with lyophilized bone without gel. On the contrary, lyophilized bone undergo a resorption process, and a fibrous tissue often fills the spaces between chips. A histiocytic/giant-cell reaction is sometimes present. Otherwise, no differences have been found concerning microstructure. Our findings show the reliability of the methodology used to monitor early bone repair. The completion of the study and the evaluation of the ultimate clinical outcome are necessary in order to verify PG in vivo effects in orthopedic surgery.

Evaluation of mechanical properties and biological response of an alumina-forming Ni-free ferritic alloy.

PM 2000 is a Ni-free oxide dispersion strengthened Fe-20Cr-5Al alloy able to develop a fine, dense and tightly adherent alpha-alumina scale during high-temperature oxidation. Despite the high temperature involved during thermal oxidation (1100 degrees C), microstructural changes in the candidate material, a hot rolled product, hardly occurs. Consequently, the good mechanical properties of the as-received material are not significantly affected. Moreover, due to the high compressive residual stresses at the alumina scale, an increase in the fatigue limit from 500 to 530 MPa is observed. Such stresses also account for the high capability of the coating/metal system to withstand more than 1% tensile deformation without cracking. The biocompatibility of the alloy was assessed in comparison to commercial alumina. Saos-2 osteoblast-like cells were either challenged with PM 2000 particles, or seeded onto PM 2000 (with and without scale) solid samples. Viability, growth, and ALP release from cells were assessed after 3 or 7 days, while mineralization was checked at 18 days. This study has demonstrated that PM 2000 with and without scale are capable of supporting in vitro growth and function of osteoblast-like cells over a period of 18 days. Results from this study suggest that the resulting alumina/alloy system combines the good mechanical properties of the alloy with the superior biocompatibility of the alpha-alumina, for which there is very good clinical experience.

The influence of alumina and ultra-high molecular weight polyethylene particles on osteoblast-osteoclast cooperation.

Particle-induced macrophage activation, mainly by UHMWPE wear, has been recognized as the biological mechanism leading to periprosthetic bone resorption, which is responsible for the loosening of the total hip replacements (THR). Ceramic-on-ceramic implants have been advocated as a means of reducing wear products. Many studies investigated the effect of alumina (Al(2)O(3)) particles on monocytes/macrophages, but only limited information are available on their participation to bone turnover. An in vitro model was performed to investigate how Al(2)O(3) and UHMWPE particles may influence the osteoblast-osteoclast interaction: human osteoblasts (HOB) were obtained from trabecular bone, while osteoclasts were derived from peripheral blood mononuclear cells (PBMC) of healthy donors. The amount of IL6, TNF alpha, GM-CSF, and other factors acting on the bone turnover, i.e. the 'receptor activator of NF kappa B' ligand (RANKL) and osteoprotegerin (OPG), was detected in culture medium of particle-challenged HOB (HOB-CM). The Al(2)O(3) and UHMWPE particles did not affect either cell viability or TNF and GM-CSF release, while the increase in IL6 release seemed to be dependent on the particle concentration. UHMWPE increased the release of RANKL from HOB, while OPG and OPG-to-RANKL ratio were significantly inhibited. The ability of HOB-CM to promote osteoclastogenesis was tested via osteoblast/monocyte cooperation: after seven days of culture UHMWPE HOB-CM induced a large amount of multinucleated TRAP-positive giant cells, as well as significantly reduced the amount of IL6, GM-CSF and RANKL in the supernatant. With regard to the inductive effect on the osteoclastogenesis, our results show that the Al(2)O(3) wear debris are less active.