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After implantation of an internal fracture fixation device, blood contacts the surface, followed by protein adsorption, resulting in either soft-tissue adhesion or matrix adhesion and mineralization. Without protein adsorption and cell adhesion under the presence of micro-motion, fibrous capsule formation can occur, often surrounding a liquid filled void at the implant-tissue interface. Clinically, fibrous capsule formation is more prevalent with electropolished stainless steel (EPSS) plates than with current commercially pure titanium (cpTi) plates. We hypothesize that this is due to lack of micro-discontinuities on the standard EPSS plates. To test our hypothesis, four EPSS experimental surfaces with varying microtopographies were produced and characterized for morphology using the scanning electron microscope, quantitative roughness analysis using laser profilometry and chemical analysis using X-ray photoelectron spectroscopy. Clinically used EPSS (smooth) and cpTi (microrough) were included as controls. Six plates of each type were randomly implanted, one on both the left and right intact tibia of 18 white New Zealand rabbits for 12 weeks, to allow for a surface interface study. The results demonstrate that the micro-discontinuities on the upper surface of internal steel fixation plates reduced the presence of liquid filled voids within soft-tissue capsules. The micro-discontinuities on the plate under-surface increased bony integration without the presence of fibrous tissue interface. These results support the hypothesis that the fibrous capsule and the liquid filled void formation occurs mainly due to lack of micro-discontinuities on the polished smooth steel plates and that bony integration is increased to surfaces with higher amounts of micro-discontinuities. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 705-715, 2018.

After implantation of an internal fracture fixation device, blood contacts the surface, followed by protein adsorption, resulting in either soft-tissue adhesion or matrix adhesion and mineralization. Without protein adsorption and cell adhesion under the presence of micro-motion, fibrous capsule formation can occur, often surrounding a liquid filled void at the implant-tissue interface. Clinically, fibrous capsule formation is more prevalent with electropolished stainless steel (EPSS) plates than with current commercially pure titanium (cpTi) plates. We hypothesize that this is due to lack of micro-discontinuities on the standard EPSS plates. To test our hypothesis, four EPSS experimental surfaces with varying microtopographies were produced and characterized for morphology using the scanning electron microscope, quantitative roughness analysis using laser profilometry and chemical analysis using X-ray photoelectron spectroscopy. Clinically used EPSS (smooth) and cpTi (microrough) were included as controls. Six plates of each type were randomly implanted, one on both the left and right intact tibia of 18 white New Zealand rabbits for 12 weeks, to allow for a surface interface study. The results demonstrate that the micro-discontinuities on the upper surface of internal steel fixation plates reduced the presence of liquid filled voids within soft-tissue capsules. The micro-discontinuities on the plate under-surface increased bony integration without the presence of fibrous tissue interface. These results support the hypothesis that the fibrous capsule and the liquid filled void formation occurs mainly due to lack of micro-discontinuities on the polished smooth steel plates and that bony integration is increased to surfaces with higher amounts of micro-discontinuities. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 705-715, 2018.

Soft tissue-implant adhesion is often required for implant integration into the body; however, in some situations, the tissue is required to glide freely over an implant. In the case of distal radius fracture treatment, current literature describes how titanium and its alloys tend to lead to more intra-tendon inflammatory reactions compared with stainless steel. This leads to tendon-implant adhesion and damage possibly causing limited palmar flexion and even tendon rupture. The goal of this study was to analyze the effect of different surface polishings of titanium and titanium molybdenum implants on soft tissue reactions in vivo, with the aim to prevent direct soft tissue adhesion. Using a nonfracture model, to allow for study of the soft-tissue-implant surface interactions only, six surface variants of the same plate design were implanted onto the tibia of 24 New Zealand white rabbits and left in situ for 12 weeks. Results indicate that paste polished commercially pure titanium and titanium molybdenum alloy had the least soft tissue adhesion, with the concomitant development of a soft tissue capsule. Surface topography did not appear influence the thickness of the connective tissue surrounding the plate. Therefore, suitable surface polishing could be applied to plates for clinical use, where free gliding of tissues is required. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2012.

This study investigated the quality and quantity of healing of a bone defect following intramedullary reaming undertaken by two fundamentally different systems; conventional, using non-irrigated, multiple passes; or suction/irrigation, using one pass. The result of a measured re-implantation of the product of reaming was examined in one additional group. We used 24 Swiss mountain sheep with a mean tibial medullary canal diameter between 8 mm and 9 mm. An 8 mm ‘napkin ring’ defect was created at the mid-diaphysis. The wound was either surgically closed or occluded. The medullary cavity was then reamed to 11 mm. The Reamer/Irrigator/Aspirator (RIA) System was used for the reaming procedure in groups A (RIA and autofilling) and B (RIA, collected reamings filled up), whereas reaming in group C (Synream and autofilling) was performed with the Synream System. The defect was allowed to auto-fill with reamings in groups A and C, but in group B, the defect was surgically filled with collected reamings. The tibia was then stabilised with a solid locking Unreamed Humerus Nail (UHN), 9.5 mm in diameter. The animals were killed after six weeks. After the implants were removed, measurements were taken to assess the stiffness, strength and callus formation at the site of the defect. There was no significant difference between healing after conventional reaming or suction/irrigation reaming. A significant improvement in the quality of the callus was demonstrated by surgically placing captured reamings into the defect using a graft harvesting system attached to the aspirator device. This was confirmed by biomechanical testing of stiffness and strength. This study suggests it could be beneficial to fill cortical defects with reaming particles in clinical practice, if feasible.

SummaryNon-metallic implants have the advantage over metallic implants of reduction in artefact with CT and MR diagnostic imaging. In-vivo performance of a carbon fibre reinforced polyetheretherketone radiolucent plate (Snake Plate [SP]) with high stiffness, and fixed angle converging screws was compared with a seven-hole titanium Locking Compression Plate (LCP), using a sheep tibial osteotomy model (gap 0.6 mm). The sheep were divided into two groups, and the osteotomies were stabilized with a SP (n=6) or a LCP (n=6). The callus dimensions were measured radiographically at zero, two, four, six and eight weeks. The animals were euthanatized after eight weeks. Osteotomised and contralateral tibiae were tested in pairs torsion, to determine strength and stiffness. In the radii of six separate sheep, initial vascular disturbance after plate implantation was evaluated. All of the sheep of the SP and LCP groups showed maximal callus areas at six weeks. The differences between the groups, in callus dimension, were not significant at any time point. The median values for relative reduction (100 x [operated – contralateral] / contralateral) in strength of osteotomized tibiae was ™13.93% for the SP group and ™7.49% for the LCP group (p = 0.5228), and for stiffness it was ™24.44 % for the SP group and ™27.08% for the LCP group (p = 0.6481). Neither the SP nor LCP caused any notable disturbance in periosteal circulation. The SP appears to represent a valuable alternative to metallic implants for shaft fracture repair. The main advantages of the SP are radiolucency, high deformation resistance, internal fixator concept and converging screw configuration for optimal loading conditions in the bone-implant construct.

Carbon fiber-reinforced polyetheretherketone (CF/PEEK) is a thermoplastic composite biomaterial exhibiting properties suitable for load-bearing orthopedic implants. However, the hydrophobic surface of CF/PEEK implants induces the deposition of a peri-implant fibrous tissue capsule preventing bone apposition. However, if bone apposition was improved, the use of CF/PEEK in orthopedics could be increased as it has many advantages compared with metallic implants. In this study, CF/PEEK screws were coated with titanium (Ti) using two different techniques, namely vacuum plasma spraying (VPS) and physical vapor deposition (PVD) with uncoated screws as controls. These coatings were characterized and implanted in a loaded sheep tibia model. In the characterization of the screw surfaces using microscopy techniques, the uncoated screws were seen to have an irregular surface. The PVD coating appeared smooth and consistent, whereas the VPS coating appeared to be a rough coating with some inhomogeneities, which did not cover the entire surface area. Nevertheless, in the ex vivo analysis the VPS-coated screws had a screw removal torque which was statistically greater than uncoated and PVD-coated screws (p ≤ 0.002 for both comparisons). Additionally, the VPS-coated screws had a statistically higher bone contact area than the uncoated screws (p = 0.006), whereas no statistical difference was detected between VPS and PVD coating types (p = 0.11). Thereby illustrating that Ti coating of CF/PEEK screws significantly improve bone apposition and removal torque compared with uncoated CF/PEEK screws.

Implant loosening is an unresolved complication associated with prosthetics. Previous studies report improved osseointegration with hydroxyapatite (HA) or tri-calcium phosphate coatings. Unfortunately, the brittleness and low strength of these coatings in adhesion to the implant or internal cohesion is problematic, restricting their use. Anodic plasma-chemical (APC) treatment, an advanced anodisation method, allows for porous oxide layer formation with incorporation of calcium and phosphate directly into the oxide. This produces superior adhesive strength than a conventional coating of calcium phosphate offering potential for long-term osseointegration. Although the cytocompatibility of several APC treatments have been previously shown, this study was the first to investigate the biocompatibility and osteoconductivity of APC surfaces in vivo when compared with standard HA coated and noncoated commercially pure titanium implant cortical screws. Sample screws were implanted in female Swiss alpine sheep for 12 weeks. Bone remodelling in situ, differences in bone apposition resulting in cortical thickening as well as peak removal torque measurements were assessed. We found no significant differences between the tested coatings and no delamination was observed with any of the APC-treated surfaces. The results suggest that APC-treated samples have similar biological performance to HA-coated screws. In our opinion, APC treatment, which also has superior binding strength to the base metal compared with standard HA coatings as well as similar biocompatibility as shown here, holds great potential for biomedical applications. Now that the in vivo biocompatibility has been proven, the work is being extended to more challenging in vivo models.

Non-metallic implants have the advantage over metallic implants of reduction in artefact with CT and MR diagnostic imaging. In-vivo performance of a carbon fibre reinforced polyetheretherketone radiolucent plate (Snake Plate [SP]) with high stiffness, and fixed angle converging screws was compared with a seven-hole titanium Locking Compression Plate (LCP), using a sheep tibial osteotomy model (gap 0.6 mm). The sheep were divided into two groups, and the osteotomies were stabilized with a SP (n = 6) or a LCP (n = 6). The callus dimensions were measured radiographically at zero, two, four, six and eight weeks. The animals were euthanatized after eight weeks. Osteotomised and contralateral tibiae were tested in pairs torsion, to determine strength and stiffness. In the radii of six separate sheep, initial vascular disturbance after plate implantation was evaluated. All of the sheep of the SP and LCP groups showed maximal callus areas at six weeks. The differences between the groups, in callus dimension, were not significant at any time point. The median values for relative reduction (100 x [operated contralateral] / contralateral) in strength of osteotomized tibiae was -13.93% for the SP group and -7.49% for the LCP group (p = 0.5228), and for stiffness it was -24.44% for the SP group and -27.08% for the LCP group (p = 0.6481). Neither the SP nor LCP caused any notable disturbance in periosteal circulation. The SP appears to represent a valuable alternative to metallic implants for shaft fracture repair. The main advantages of the SP are radiolucency, high deformation resistance, internal fixator concept and converging screw configuration for optimal loading conditions in the bone-implant construct.

Der neue winkelstabile Fixateur intern minimiert im Vergleich zur konventionellen Platten- und Marknagelosteosynthese die implantatinduzierte Minderperfusion des Knochens. Studienziel war es, den Frakturheilungsverlauf mit Fixateur intern und den Standardverfahren unaufgebohrte Marknagelung und konventionelle Plattenosteosynthese zu vergleichen.

Two calcium phosphate cements, one monophasic and the other biphasic, have been used as bone void filler in a sheep model. The cements were injected into a slot defect in the proximal tibia and into a cylindrical defect in the distal femur. In this study, we focused on the resorption pattern of the two cement formulations and the subsequent biologic reaction. Bone remodeling occurred synchronously with the resorption of the implant material in a creeping substitution process. Cracks and pores in the monophasic cement were filled with osseous tissues. The biphasic cement showed faster resorption of the matrix. The more slowly resorbing granules were surrounded by newly grown bone, thus providing an inverse scaffold for cancellous bone regeneration. In highly loaded areas, the long-term support function of the fixation appears to be critical. Because cortical bridging of the defects was seen in only one case, it can be concluded that calcium-phosphate cements are preferentially suitable as cancellous bone substitute materials.