Manufacturing conditioned wear of all-ceramic knee prostheses

To date, bioceramics have not been applied successfully in total knee joint endoprostheses. Sintered bioceramics can be machined only by grinding and polishing processes. Due to high quality requirements, there are significant challenges with regard to these machining technologies. An automated precise economical process chain for the manufacturing of a new all-ceramic knee implant design was developed. It was assumed the geometrical accuracy and the shape of implant contact geometry specified during the manufacturing process has a substantial influence on the wear behavior of the prosthesis. The importance of the surface quality of the ceramic implant surface remains unclear and warrants future examination

Biodegradation of a magnesium alloy implant in the intercondylar femoral notch showed an appropriate response to the synovial membrane in a rabbit model in vivo

Degradable magnesium alloys are promising biomaterials for orthopedic applications. The aim of this study was to evaluate the potential effects on both the synovial membrane (synovialis) and the synovial fluid (synovia) of the degradation products of a MgYREZr-pin implanted in the intercondylar femoral notch in a rabbit model. Thirty-six animals were randomized into two groups (MgYREZr or Ti6Al4V alloy) of 18 animals each. Each group was then divided into three subgroups with implantation periods of 1, 4, and 12 weeks, with six animals in each subgroup. The initial inflammatory reaction caused by the surgical trauma declined after 12 weeks of implantation, and elucidated a progressive recovery of the synovial membrane. Compared with control Ti6Al4V pins, there were no significant differences between the groups. However, after 12 weeks, recovery of the synovial membrane was more advanced in the titanium group, in which 92% showed no signs of synovitis, than in the magnesium group. A cytotoxicity test with L929 cells and human osteoblasts (HOB) was also conducted, according to EN ISO 10993-5/12, and no toxic leachable products were observed after 24 h of incubation. In conclusion, the MgYREZr alloy seems to be a suitable material for intra-articular degradable implants. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav

Influence of stress on the degradation behavior of Mg LAE442 implant systems

In this paper the performance of a magnesium based implant system is analyzed. A special emphasis is placed on the impact of stress on the corrosion behavior of the magnesium alloy. An implant system containing a plate and 4 corresponding screws is machined from Mg LAE442. Its corrosion behavior is tested in-vivo in New Zealand White Rabbits for 6 and 12 weeks of implantation. The plate is monocortically fixated on the medial tibia. At the interface between screw and plate increased corrosion is observed. This phenomenon is stronger on the caudal side of the screw. Parallel to the in-vivo test the influence of stress load on the corrosion rate is analyzed for LAE442 in in-vitro tests. Compressive load is applied on cylindrical specimens in axial direction and the corrosion rate is measured in 0.9 wt% NaCl solution by eudiometry and mass loss. Additionally rectangular samples are bent to apply tensile stress on the surface. A drop of 5 wt% NaCl is deposited on the surface and the corrosion is evaluated by microscopic images. It is shown that stress essentially influences the corrosion rate. While tensile stress decreases the corrosion, compressive stress leads to higher corrosion rates

Biomechanical properties of a novel biodegradable magnesium-based interference screw

Magnesium-based interference screws may be an alternative in anterior/posterior cruciate ligament reconstruction. The well-known osteoconductive effects of biodegradable magnesium alloys may be useful. It was the purpose of this study to evaluate the biomechanical properties of a magnesium based interference screw and compare it to a standard implant. A MgYREZr-alloy interference screw and a standard implant (Milagro®; De Puy Mitek, Raynham, MA, USA) were used for graft fixation. Specimens were placed into a tensile loading fixation of a servohydraulic testing machine. Biomechanical analysis included pretensioning of the constructs at 20 N for 1 min following cyclic pretensioning of 20 cycles between 20 and 60 N. Biomechanical elongation was evaluated with cyclic loading of 1000 cycles between 50 and 200 N at 0.5 Hz. Maximum load to failure was 511.3±66.5 N for the Milagro® screw and 529.0±63.3 N for magnesium-based screw (ns, P=0.57). Elongations after preload, during cyclical loading and during failure load were not different between the groups (ns, P>0.05). Stiffness was 121.1±13.8 N/mm for the magnesiumbased screw and 144.1±18.4 for the Milagro® screw (ns, P=0.32). MgYREZr alloy interference screws show comparable results in biomechanical testing to standard implants and may be an alternative for anterior cruciate reconstruction in the future

In vivo evaluation of a magnesium-based degradable intramedullary nailing system in a sheep model

© 2015 Acta Materialia Inc. The biocompatibility and the degradation behavior of the LAE442 magnesium-based intramedullary interlocked nailing system (IM-NS) was assessed in vivo in a comparative study (stainless austenitic steel 1.4441LA) for the first time. IM-NS was implanted into the right tibia (24-week investigation period; nails/screws diameter: 9 mm/3.5 mm, length: 130 mm/15-40 mm) of 10 adult sheep (LAE442, stainless steel, n = 5 each group). Clinical and radiographic examinations, in vivo computed tomography (CT), ex vivo micro-computed tomography (μCT), mechanical and histological examinations and element analyses of alloying elements in inner organs were performed. The mechanical examinations (four-point bending) revealed a significant decrease of LAE442 implant stiffness, force at 0.2% offset yield point and maximum force. Periosteal (new bone formation) and endosteal (bone decline) located bone alterations occurred in both groups (LAE442 alloy more pronounced). Moderate gas formation was observed within the LAE442 alloy group. The CT-measured implant volume decreased slightly (not significant). Histologically a predominantly direct bone-to-implant interface existed within the LAE442 alloy group. Formation of a fibrous tissue capsule around the nail occurred in the steel group. Minor inflammatory infiltration was observed in the LAE442 alloy group. Significantly increased quantities of rare earth elements were detected in the LAE442 alloy group. μCT examination showed the beginning of corrosion in dependence of the surrounding tissue. After 24 weeks the local biocompatibility of LAE442 can be considered as suitable for a degradable implant material. Statement of Significance An application oriented interlocked intramedullary nailing system in a comparative study (degradable magnesium-based LAE442 alloy vs. steel alloy) was examined in a sheep model for the first time. We focused in particular on the examination of implant degradation by means of (μ-)CT, mechanical properties (four-point bending), clinical compatibility, local bone reactions (X-ray and histology) and possible systemic toxicity (histology and element analyses of inner organs). A significant decrease of magnesium (LAE442 alloy) implant stiffness and maximum force occurred. Moderate not clinically relevant gas accumulation was determined. A predominantly direct bone-to-implant contact existed within the magnesium (LAE442 alloy) group compared to an indirect contact in the steel group. Rare earth element accumulation could be observed in inner organs but H&E staining was inconspicuous

Comparative in vitro study and biomechanical testing of two different magnesium alloys.

In this in vitro study, magnesium plates of ZEK100 and MgCa0.8 alloy similar to common titanium alloy osteosynthesis plates were investigated as degradable biomedical materials with a focus on primary stability. Immersion tests were performed in Hank's Balanced Salt Solution at 37. The bending strength of the samples was determined using the four-point bending test according to ISO 9585:1990. The initial strength of the noncorroded ZEK100 plate was 11% greater than that of the MgCa0.8 plate; both were approximately 65% weaker than a titanium plate. The bending strength was determined after 48 and 96 h of immersion in Hank's Balanced Salt Solution; both magnesium alloys decreased by approximately 7% after immersion for 96 h. The degradation rate and the Mg(2+) release of ZEK100 were lower than those of MgCa0.8. Strong pitting and filiform corrosion were observed in the MgCa0.8 samples after 96 h of immersion. The surface of the ZEK100 plates exhibited only small areas of filiform corrosion. The results of this in vitro study indicate that the ZEK100 alloy may be more suitable for biomedical applications