Soft tissue response to a new austenitic stainless steel with a negligible nickel content.

This study evaluates the soft tissue response to a new austenitic stainless steel with a low nickel content (P558) in comparison with a conventional stainless steel (SSt)and a titanium alloy (Ti6Al4V). Previous findings showed its in vitro biocompatibility by culturing P558 with healthy and osteoporotic osteoblasts and its in vivo effectiveness as bone implant material. Regarding its use as a material in osteosynthesis,P558 biocompatibility when implanted in soft tissues, as subcutis and muscle, was assessed. Disks and rods of these metals were implanted in rat subcutis and in rabbit muscle, respectively. Four and twelve weeks post surgery implants with surrounding tissue were retrieved for histologic and histomorphometric analysis: fibrous capsule thickness and new vessel formation were measured. Around all implanted materials, light microscopy highlighted a reactive and fibrous capsule formation coupled with ongoing neoangiogenesis both in rats and in rabbits. Histomorphometric measurements revealed a stronger inflammatory response,in terms of capsule thickness,surrounding SSt implants (9.8% Ni content) both in rat subcutis and in rabbit muscle independently of shape and site of implantation. A progressive decrease in capsule thickness around P558 (<0.02% Ni content) and Ti6Al4V, respectively, was seen. Regarding new vessel density, the data showed a different response dependent on the site of implantation. However,in the light of the previous and present studies, P558 is a good material, instead of titanium alloys, in orthopedic research.

A new austenitic stainless steel with a negligible amount of nickel: an in vitro study in view of its clinical application in osteoporotic bone.

A biomaterial named P558 is a new austenitic stainless steel (SS) with a negligible amount of Ni (<0.20%). In previous in vitro and in vivo studies it was compared with conventional SS and Ti6Al4V and shown to be a promising material in orthopedics. Because osteoporosis is a type of pathology very often encountered in implanted patients and can be studied with in vitro models, the purpose of the present study was to evaluate P558 in vitro through comparison of normal (nOB) with osteopenic (oOB) bone-derived primary rat osteoblasts. Osteoblasts were cultured directly on P558 and polystyrene as controls for 72 h. Osteoblast proliferation, adhesion, and activity (ALP, OC, TGF-beta1, and IL-6) were evaluated at 24 and 72 h. Results demonstrated that the growth of nOB and oOB cultured on P558 was not affected negatively when compared to control. Cells on P558 did not show any alteration in terms of adhesion, proliferation, and metabolic marker production in nOB and oOB cultures, and a significant increase in ALP, OC, and TGF-beta1 production was observed. SEM images revealed no alteration in cell morphology. The current findings demonstrate that P558 promotes osteoblast proliferation, activation, and differentiation not only in normal bone, but also in osteopenic bone-derived osteoblasts.

Biomaterials in orthopedic surgery: effects of a nickel-reduced stainless steel on in vitro proliferation and activation of human osteoblasts.

A new austenitic stainless steel compound, P558, has been widely recognized to have good mechanical properties, excellent potential for corrosion resistance and negligible nickel ion release, making it a promising substitute for more expensive metallic prostheses with limited machinable features. The effect of P558 was studied in vitro and human osteoblast- like cells (MG63) were cultured directly on P558, Ti6Al4V alloy (Ti), and polystyrene (Control) for 72 hours. Osteoblast functions were evaluated by assaying cell proliferation and synthetic activity after 1.25(OH)2D3 stimulation. Results demonstrated that growth of MG63 on P558 was not negatively affected when compared to the Ti and Control groups and showed no alteration in the production of ALP, NO and PICP. Moreover, IL-6 was lower, whereas OC and TGFbeta1 were significantly higher. SEM images revealed that cells proliferated and differentiated on P558 without any alteration in their morphology. The current findings have demonstrated that P558 promotes osteoblast proliferation, activation and differentiation without negative effects and, thus, its good biocompatibility when used for orthopedic application.

A new austenitic stainless steel with negligible nickel content: an in vitro and in vivo comparative investigation.

New nickel (Ni)-reduced stainless-steel metals have recently been developed to avoid sensitivity to Ni. In the present study, an austenitic Ni-reduced SSt named P558 (P558, Böhler, Milan, Italy) was studied in vitro on primary osteoblasts and in vivo after bone implantation in the sheep tibia, and was compared to ISO 5832-9 SSt (SSt) and Ti6Al4V. Cells were cultured directly on P558 and Ti6Al4V. Cells cultured on polystyrene were used as controls. Osteoblast proliferation, viability and synthetic activity were evaluated at 72 h by assaying WST1, alkaline phosphatase activity (ALP), nitric oxide, pro-collagen I (PICP), osteocalcin (OC), transforming growth factor-beta1 (TGFbeta-1) and interleukin-6 (IL-6) after 1.25(OH)2D3 stimulation. Under general anaesthesia, four sheep were submitted for bilateral tibial implantation of P558, SSt and Ti6Al4V rods. In vitro results demonstrated that the effect of P558 on osteoblast viability, PICP, TGF beta-1, tumor necrosis factor-alpha production did not significantly differ from that exerted by Ti6Al4V and controls. Furthermore, P558 enhanced osteoblast differentiation, as confirmed by ALP and OC levels, and reduced IL-6 production. At 26 weeks, the bone-to-implant contact was higher in P558 than in SSt (28%, p<0.005) and Ti6Al4V (4%, p<0.05), and was higher in Ti6Al4V than in SSt (22%, p<0.005). The tested materials did not affect bone microhardness in pre-existing host bone as evidenced by the measurements taken at 1000 microm from the bone-biomaterial interface (F=1.89, ns). At the bone-biomaterial interface the lowest HV value was found for SSt, whereas no differences in HV were observed between materials (F=1.55, ns). The current findings demonstrate P558 biocompatibility both in vitro and in vivo, and osteointegration processes are shown to be significantly improved by P558 as compared to the other materials tested.