In vivo investigation of open-pored magnesium scaffolds LAE442 with different coatings in an open wedge defect.

The magnesium alloy LAE442 showed promising results as a bone substitute in numerous studies in non-weight bearing bone defects. This study aimed to investigate the in vivo behavior of wedge-shaped open-pored LAE442 scaffolds modified with two different coatings (magnesium fluoride (MgF2, group 1)) or magnesium fluoride/calcium phosphate (MgF2/CaP, group 2)) in a partial weight-bearing rabbit tibia defect model. The implantation of the scaffolds was performed as an open wedge corrective osteotomy in the tibia of 40 rabbits and followed for observation periods of 6, 12, 24, and 36 weeks. Radiological and microcomputed tomographic examinations were performed in vivo. X-ray microscopic, histological, histomorphometric, and SEM/EDS analyses were performed at the end of each time period. µCT measurements and X-ray microscopy showed a slight decrease in volume and density of the scaffolds of both coatings. Histologically, endosteal and periosteal callus formation with good bridging and stabilization of the osteotomy gap and ingrowth of bone into the scaffold was seen. The MgF2 coating favored better bridging of the osteotomy gap and more bone-scaffold contacts, especially at later examination time points. Overall, the scaffolds of both coatings met the requirement to withstand the loads after an open wedge corrective osteotomy of the proximal rabbit tibia. However, in addition to the inhomogeneous degradation behavior of individual scaffolds, an accumulation of gas appeared, so the scaffold material should be revised again regarding size dimension and composition.

Effect of pore size on tissue ingrowth and osteoconductivity in biodegradable Mg alloy scaffolds.

Magnesium has mechanical properties similar to those of bone and is being considered as a potential bone substitute. In the present study, two different pore sized scaffolds of the Mg alloy LAE442, coated with magnesium fluoride, were compared. The scaffolds had interconnecting pores of either 400 (p400) or 500 µm (p500). ß-TCP served as control. Ten scaffolds per time group (6, 12, 24, 36 weeks) were implanted in the trochanter major of rabbits. Histological analyses, µCT scans, and SEM/EDX were performed. The scaffolds showed slow volume decreases (week 36 p400: 9.9%; p500: 7.5%), which were accompanied by uncritical gas releases. In contrast, ß-TCP showed accelerated resorption (78.5%) and significantly more new bone inside (18.19 ± 1.47 mm3). Bone fragments grew into p400 (0.17 ± 0.19 mm3) and p500 (0.36 ± 0.26 mm3), reaching the centrally located pores within p500 more frequently. In particular, p400 displayed a more uneven and progressively larger surface area (week 36 p400: 253.22 ± 19.44; p500: 219.19 ± 4.76 mm2). A better osseointegration of p500 was indicated by significantly more trabecular contacts and a 200 µm wide bone matrix being in the process of mineralization and in permanent contact with the scaffold. The number of macrophages and foreign body giant cells were at an acceptable level concerning resorbable biomaterials. In terms of ingrown bone and integrative properties, LAE442 scaffolds could not achieve the results of ß-TCP. In this long-term study, p500 appears to be a biocompatible and more osteoconductive pore size for the Mg alloy LAE442.

Development of a Laser Powder Bed Fusion Process Tailored for the Additive Manufacturing of High-Quality Components Made of the Commercial Magnesium Alloy WE43.

Additive manufacturing (AM) has become increasingly important over the last decade and the quality of the products generated with AM technology has strongly improved. The most common metals that are processed by AM techniques are steel, titanium (Ti) or aluminum (Al) alloys. However, the proportion of magnesium (Mg) in AM is still negligible, possibly due to the poor processability of Mg in comparison to other metals. Mg parts are usually produced by various casting processes and the experiences in additive manufacturing of Mg are still limited. To address this issue, a parameter screening was conducted in the present study with experiments designed to find the most influential process parameters. In a second step, these parameters were optimized in order to fabricate parts with the highest relative density. This experiment led to processing parameters with which specimens with relative densities above 99.9% could be created. These high-density specimens were then utilized in the fabrication of test pieces with several different geometries, in order to compare the material properties resulting from both the casting process and the powder bed fusion (PBF-LB) process. In this comparison, the compositions of the occurring phases and the alloys' microstructures as well as the mechanical properties were investigated. Typically, the microstructure of metal parts, produced by PBF-LB, consisted of much finer grains compared to as-cast parts. Consequently, the strength of Mg parts generated by PBF-LB could be further increased.

Investigation of degraded bone substitutes made of magnesium alloy using scanning electron microscope and nanoindentation.

Degradable bone substitutes made of magnesium alloys are an alternative to biological bone grafts. The main advantage is that they can be manufactured location- and patient-specific. To develop and scale appropriate implants using computational models, knowledge about the mechanical properties and especially the change in the properties during the degradation process is essential. Therefore, degraded open-pored implants were investigated using scanning electron microscope and nanoindentation to find their material composition and mechanical properties. Using both techniques the correlation of the material composition and the average modulus was determined. It could be shown that the average modulus of the degradation layer is distinctly lower than that of the base material. The local average modulus of degrading implant highly depends on the magnesium concentration and the accumulation of elements from the environment. A decrease in magnesium concentration leads to a decrease in the average modulus. Thus, the degrading implant had a lower stiffness than the initial structure.

Comparison of two pore sizes of LAE442 scaffolds and their effect on degradation and osseointegration behavior in the rabbit model.

The magnesium alloy LAE442 emerged as a possible bioresorbable bone substitute over a decade ago. In the present study, using the investment casting process, scaffolds of the Magnesium (Mg) alloy LAE442 with two different and defined pore sizes, which had on average a diameter of 400 µm (p400) and 500 µm (p500), were investigated to evaluate degradation and osseointegration in comparison to a ß-TCP control group. Open-pored scaffolds were implanted in both greater trochanter of rabbits. Ten scaffolds per time group (6, 12, 24, and 36 weeks) and type were analyzed by clinical, radiographic and µ-CT examinations (2D and 3D). None of the scaffolds caused adverse reactions. LAE442 p400 and p500 developed moderate gas accumulation due to the Mg associated in vivo corrosion, which decreased from week 20 for both pore sizes. After 36 weeks, p400 and p500 showed volume decreases of 15.9 and 11.1%, respectively, with homogeneous degradation, whereas ß-TCP lost 74.6% of its initial volume. Compared to p400, osseointegration for p500 was significantly better at week 2 postsurgery due to more frequent bone-scaffold contacts, higher number of trabeculae and higher bone volume in the surrounding area. No further significant differences between the two pore sizes became apparent. However, p500 was close to the values of ß-TCP in terms of bone volume and trabecular number in the scaffold environment, suggesting better osseointegration for the larger pore size.

A simulation model for the degradation of magnesium-based bone implants.

The development of degradable bone implants, in particular made of metal materials, is an emerging field. The advantage of degradable implants is that they do not have to be removed later. In order to be able to develop and scale appropriate implants for different applications, it is necessary to know the change in mechanical properties of the implant during the degradation process in general and at different locations. One area of bone implants are bone substitute materials. They are deployed when there is a defect in the bone which cannot be filled autonomously by the body. In this study, a numerical degradation model of magnesium-based bone substitute materials is developed using the finite element method. Computational models are being developed to reduce experimental animal research in future. Magnesium is a naturally occurring material which is needed to build enzymes in the body. Additionally, magnesium has a Young's modulus close to native bone, wherefore it is attractive for medical applications with bone contact. The simulation model is based on the assumption that the degradation is a diffusion-controlled process driven by the dissolution of magnesium. The model is adapted to a 3D open-pored structure made of the magnesium alloy LAE442. Previous studies showed that implants made of LAE442 lose stiffness without a volume reduction. To simulate the change in mechanical properties, a concentration-dependent Young's modulus is assumed. With this model the formation of the degradation layer is computable as well as the change in mechanical properties, as measured by the effective Young's modulus of the structure. The movement of the interface between the not-degraded and degraded material is modelled using the level set method.

Processing and coating of open-pored absorbable magnesium-based bone implants.

Large bone defects or fractures must be treated with an implant or transplant. Resorbable implants are attractive as these require only one surgery, whereas bone autografts, which can be cut off from the same person's hip, require more than one procedure. Moreover, porous structures promote the ingrowth of the patient's bone. Thus, the objective of the present study was to develop open-pored biodegradable implant structures with different pore sizes that provide for both adequate degradation behaviour and mechanical properties that match with those of bone. The magnesium alloys LAE442 and La2 were employed in this study, as these materials are known to feature good biocompatibility and mechanical properties close to bone. It was possible to cast magnesium sponges with different pore sizes using the alloy LAE442. However, with the MgLa2 alloy, only sponges with a minimum pore size of 0.5 mm could be produced. Overall, the sponges cast with the LAE442 alloy showed higher strength, even though the strengths of the dense parts were similar in both alloys tested. In terms of castability and mechanical behaviour, the LAE442 alloy turned out to be more favourable. In order to adapt the implant degradation behaviour to the bone ingrowth behaviour, coating of the magnesium sponges with calcium phosphate and polylactic acid was also investigated. Additionally, the different coatings were tested on their adhesive forces and influences to the in-vitro degradation behaviour.