Mechanical Properties and Corrosion Rate of ZnAg3 as a Novel Bioabsorbable Material for Osteosynthesis.

Osteosynthesis in fracture treatment typically uses hardware that remains in the patient's body, which brings a permanent risk of negative side effects such as foreign body reactions or chronic inflammation. Bioabsorbable materials, however, can degrade and slowly be replaced by autologous bone tissue. A suitable material is requested to offer great biocompatibility alongside excellent mechanical properties and a reasonable corrosion rate. Zinc-silver alloys provide these characteristics, which makes them a promising candidate for research. This study investigated the aptitude as a bioabsorbable implant of a novel zinc-silver alloy containing 3.3 wt% silver (ZnAg3). Here, the tensile strength as well as the corrosion rate in PBS solution (phosphate buffered solution) of ZnAg3 were assessed. Furthermore, shear tests, including fatigue and quasi-static testing, were conducted with ZnAg3 and magnesium pins (MAGNEZIX®, Syntellix AG, Hannover, Germany), which are already in clinical use. The detected corrosion rate of 0.10 mm/year for ZnAg3 was within the proposed range for bioabsorbable implants. With a tensile strength of 237.5 ± 2.12 MPa and a shear strength of 144.8 ± 13.2 N, ZnAg3 satisfied the mechanical requirements for bioabsorbable implants. The fatigue testing did not show any significant difference between ZnAg3 and magnesium pins, whereas both materials withstood the cyclic loading. Thus, the results support the assumption that ZnAg3 is qualified for further investigation.

Biocompatibility Assessment of Zinc Alloys as a New Potential Material for Bioabsorbable Implants for Osteosynthesis.

In the last several years, zinc and its alloys have come into focus as bioabsorbable materials by qualifying themselves with an excellent corrosion rate, mechanical properties, anti-bacterial effects. and considerable biocompatibility. In this study, the biocompatibility of zinc-silver alloys containing 3.3 wt% silver (ZnAg3) was assessed by evaluating their cell viability, the proliferation rate, and the cell toxicity. Two alloys were investigated in which one was phosphated and the other was non-phosphated. The alloys were tested on human osteoblasts (hOb), which are, to a large extent, responsible for bone formation and healing processes. The performance of the phosphated alloy did not differ significantly from the non-phosphated alloy. The results showed a promising biocompatibility with hOb for both alloys equally in all conducted assays, qualifying ZnAg3 for further investigations such as in vivo studies.

Effect of 20 µm thin ceramic coatings of hydroxyapatite, bioglass, GB14 and Beta-Tricalciumphosphate with copper on the biomechanical stability of femoral implants.

In the present work, we test four thin coatings for titanium implants, namely, bioglass, GB14, Beta-Tricalciumphosphate (ß-TCP) and hydroxyapatite (HA) with and without incorporated copper ions for their osteointegrative capacity. A rabbit drill hole model for time intervals up to 24 weeks was used in this study. Implant fixation was evaluated by measuring shear strength of the implant/bone interface. Quantitative histological analysis was performed for the measurements of bone contact area. Implants with and without copper ions were compared after 24 weeks. Thin coatings of GB14, HA or TCP on titanium implants demonstrated high shear strength during the entire test period of up to 24 weeks. Results confirmed osteointegrative properties of the coatings and did not reveal any negative effect of copper ions on osteointegration. The integration of copper in degradable osteoconductive coatings with a thickness of approx. 20 µm represents a promising method of achieving antibacterial shielding during the entire period of bone healing while at the same time improving osteointegration of the implants.

About 3D Printability of Thermoplastic Collagen for Biomedical Applications.

With more than 1.5 million total knee and hip implants placed each year, there is an urgent need for a drug delivery system that can effectively support the repair of bone infections. Scaffolds made of natural biopolymers are widely used for this purpose due to their biocompatibility, biodegradability, and suitable mechanical properties. However, the poor processability is a bottleneck, as highly customizable scaffolds are desired. The aim of the present research is to develop a scaffold made of thermoplastic collagen (TC) using 3D printing technology. The viscosity of the material was measured using a rheometer. A 3D bioplotter was used to fabricate the scaffolds out of TC. The mechanical properties of the TC scaffolds were performed using tension/compression testing on a Zwick/Roell universal testing machine. TC shows better compressibility with increasing temperature and a decrease in dynamic viscosity (η), storage modulus (G'), and loss modulus (G″). The compressive strength of the TC scaffolds was between 3-10 MPa, depending on the geometry (cylinder or cuboid, with different infills). We have demonstrated for the first time that TC can be used to fabricate porous scaffolds by 3D printing in various geometries.

Alternative Geometries for 3D Bioprinting of Calcium Phosphate Cement as Bone Substitute.

In the literature, many studies have described the 3D printing of ceramic-based scaffolds (e.g., printing with calcium phosphate cement) in the form of linear structures with layer rotations of 90°, although no right angles can be found in the human body. Therefore, this work focuses on the adaptation of biological shapes, including a layer rotation of only 1°. Sample shapes were printed with calcium phosphate cement using a 3D Bioplotter from EnvisionTec. Both straight and wavy spokes were printed in a round structure with 12 layers. Depending on the strand diameter (200 and 250 µm needle inner diameter) and strand arrangement, maximum failure loads of 444.86 ± 169.39 N for samples without subsequent setting in PBS up to 1280.88 ± 538.66 N after setting in PBS could be achieved.

Feasibility of Implant Strain Measurement for Assessing Mandible Bone Regeneration.

Nonunion is one of the most dreaded complications after operative treatment of mandible fractures or after mandible reconstruction using vascularized and non-vascularized bone grafts. Often diagnosis is made at advanced stage of disease when pain or complications occur. Devices that monitor fracture healing and bone regeneration continuously are therefore urgently needed in the craniomaxillofacial area. One promising approach is the strain measurement of plates. An advanced prototype of an implantable strain measurement device was tested after fixation to a locking mandible reconstruction plate in multiple compression experiments to investigate the potential functionality of strain measurement in the mandibular region. Compression experiments show that strain measurement devices work well under experimental conditions in the mandibular angle and detect plate deformation in a reliable way. For monitoring in the mandibular body, the device used in its current configuration was not suitable. Implant strain measurement of reconstruction plates is a promising methodical approach for permanent monitoring of bone regeneration and fracture healing in the mandible. The method helps to avoid or detect complications at an early point in time after operative treatment.

Fixation Performance of Bioabsorbable Zn-6Ag Pins for Osteosynthesis.

Bioabsorbable implants have become the focus of the latest research for new bone implant materials. With favorable characteristics such as compatible mechanical characteristics, no long-term side effects, and even osteogenesis enhancing properties they seem to be the future of osteosynthesis. Besides these characteristics, they must perform on the same level as traditional implant materials regarding their mechanical support for bone healing. A particular focus in the research for bioabsorbable implants has been on metal alloys, as these have particularly good mechanical properties such as excellent maximum force and high stability. This study focused on the shear strength of new bioabsorbable zinc and magnesium pins in comparison to traditional implants such as K-wires and cancellous bone screws in bone-implant connections. During quasi-static and fatigue loading experiments, magnesium pins (MAGNEZIX, Syntellix AG, Hannover, Germany) and new zinc silver pins (Zn-6Ag) by Limedion (Limedion GmbH., Mannheim, Germany) were compared with conventional osteosynthetic materials. The pins made of the new bioabsorbable alloys withstood the cyclic loads to the same extent as the conventional osteosynthesis materials. In the quasi-static loading, it was shown that the novel Zn-6Ag from Limedion has the same shear strength as the magnesium pin from Syntellix, which is already in clinical use. In addition, the zinc pin showed significantly better shear strength compared to osteosynthesis with K-wires (p < 0.05).

Influence of 3D Printing Parameters on the Mechanical Stability of PCL Scaffolds and the Proliferation Behavior of Bone Cells.

Introduction The use of scaffolds in tissue engineering is becoming increasingly important as solutions need to be found for the problem of preserving human tissue, such as bone or cartilage. In this work, scaffolds were printed from the biomaterial known as polycaprolactone (PCL) on a 3D Bioplotter. Both the external and internal geometry were varied to investigate their influence on mechanical stability and biocompatibility. Materials and Methods: An Envisiontec 3D Bioplotter was used to fabricate the scaffolds. First, square scaffolds were printed with variations in the strand width and strand spacing. Then, the filling structure was varied: either lines, waves, and honeycombs were used. This was followed by variation in the outer shape, produced as either a square, hexagon, octagon, or circle. Finally, the internal and external geometry was varied. To improve interaction with the cells, the printed PCL scaffolds were coated with type-I collagen. MG-63 cells were then cultured on the scaffolds and various tests were performed to investigate the biocompatibility of the scaffolds. Results: With increasing strand thickness and strand spacing, the compressive strengths decreased from 86.18 + 2.34 MPa (200 µm) to 46.38 + 0.52 MPa (600 µm). The circle was the outer shape with the highest compressive strength of 76.07 + 1.49 MPa, compared to the octagon, which had the lowest value of 52.96 ± 0.98 MPa. Varying the external shape (toward roundness) geometry, as well as the filling configuration, resulted in the highest values of compressive strength for the round specimens with honeycomb filling, which had a value of 91.4 + 1.4 MPa. In the biocompatibility tests, the round specimens with honeycomb filling also showed the highest cell count per mm2, with 1591 ± 239 live cells/mm2 after 10 days and the highest value in cell proliferation, but with minimal cytotoxic effects (9.19 ± 2.47% after 3 days).

Mechanical Analysis and Corrosion Analysis of Zinc Alloys for Bioabsorbable Implants for Osteosynthesis.

Zinc alloys have recently been researched intensely for their great properties as bioabsorbable implants for osteosynthesis. Pure zinc (Zn) itself has relatively poor strength, which makes it insufficient for most clinical use. Research has already proven that the mechanical strength of zinc can be enhanced significantly by alloying it with silver. This study evaluated zinc silver alloys (ZnAg) as well as novel zinc silver titanium alloys (ZnAgTi) regarding their mechanical properties for the use as bioabsorbable implants. Compared to pure zinc the mechanical strength was enhanced significantly for all tested zinc alloys. The elastic properties were only enhanced significantly for the zinc silver alloys ZnAg6 and ZnAg9. Regarding target values for orthopedic implants proposed in literature, the best mechanical properties were measured for the ZnAg3Ti1 alloy with an ultimate tensile strength of 262 MPa and an elongation at fracture of 16%. Besides the mechanical properties, the corrosion rates are important for bioabsorbable implants. This study tested the corrosion rates of zinc alloys in PBS solution (phosphate buffered solution) with electrochemical corrosion measurement. Zinc and its alloys showed favorable corrosion rates, especially in comparison to magnesium, which has a much lower degradation rate and no buildup of hydrogen gas pockets during the process. Altogether, this makes zinc alloys highly favorable for use as material for bioabsorbable implants for osteosynthesis.

A Method for the Evaluation of Early Osseointegration of Implant Materials Ex Vivo: Human Bone Organ Model.

In the present work, an ex vivo organ model using human bone (explant) was developed for the evaluation of the initial osseointegration behavior of implant materials. The model was tested with additive manufactured Ti6Al4V test substrates with different 3D geometries. Explants were obtained from patients who underwent total knee replacement surgery. The tibial plateaus were used within 24 h after surgery to harvest bone cylinders (BC) from the anterior side using hollow burrs. The BCs were brought into contact with the test substrate and inserted into an agarose mold, then covered with cell culture media and subjected to the external load of 500 g. Incubation was performed for 28 days. After 28d the test substrate was removed for further analysis. Cells grown out BC onto substrate were immunostained with DAPI and with an antibody against Collagen-I and alkaline phosphatase (ALP) for visualization and cell counting. We show that cells stayed alive for up to 28d in our organ model. The geometry of test substrates influences the number of cells grown onto substrate from BCs. The model presented here can be used for testing implant materials as an alternative for in vitro tests and animal models.