Surface pretreatment for prolonged survival of cemented tibial prosthesis components: full- vs. surface-cementation technique]

Aseptic loosening of tibial components due to degradation of the interface between bone cement and metallic tibial shaft component is still a persistent problem, particularly for surface-cemented tibial components. The surface cementation technique has important clinical meaning in case of revision and for avoidance of stress shielding. This study was done to prove crack formation in the bone cement near the metallic surface when this is not coated. We propose a newly developed coating process by SiOx-PVD layering to avoid crack formation. A biomechanical model for a vibration fatigue test was done to prove that crack formation can be significantly reduced in the case of coated surfaces. It was found that coated tibial components showed a highly significant reduction of cement cracking near the metal/bone cement interface (p < 0.01) and a significant reduction of gap formation in the metal-to-bone cement interface (p < 0.05). Coating dramatically reduces hydrolytic- and stress-related crack formation at the prosthesis metal/bone cement interface. This leads to a more homogenous load transfer into the cement mantle which should reduce the frequency of loosening in the metal/bone cement/bone interfaces. With surface coating of the tibial component it should become possible that surface-cemented TKAs reveal similar loosening rates as TKAs both surface- and stem-cemented. This would be an important clinical advantage since it is believed that surface cementing reduces metaphyseal bone loss in the case of revision and stress shielding for a better bone health.     

A wax barrier to simulate bone resorption for pre-clinical laboratory models of cemented total hip replacements

Pre-clinical tests are often performed to screen new implant designs, surgical techniques, and cement formulations. In this work, we developed a technique to simulate the cement–bone morphology found with postmortem retrieved cemented hip replacements. With this technique, a soy wax barrier is created along the endosteal surface of the bone, prior to cementing of the femoral component. This approach was applied to six fresh frozen human cadaver femora and the resulting cement–bone morphology and micromotion following application of torsional loads were measured on a transverse section of each bone. The contact fraction between cement and bone for the wax barrier specimens (6.4±5.7%, range: 0.5–15%) was similar to that found in postmortem retrievals (10.5±10.3%, range: 0.4–32.5%). Micro-motions at the cement–bone interface for the wax barrier specimens (0.5±1.06 mm, range: 0.005–2.66) were similar, but on average larger than those found with postmortem retrievals (0.092±0.22 mm, range: 0.002–0.73). The use of a wax barrier coating technique could improve experimental pre-clinical tests because it produces a cement–bone interface similar to those of functioning cemented components obtained following in vivo service.     

Increased initial cement–bone interlock correlates with reduced total knee arthroplasty micro-motion following in vivo service

Aseptic loosening of cemented tibial components in total knee arthroplasty (TKA) has been related to inadequate cement penetration into the trabecular bone bed during implantation. Recent postmortem retrieval work has also shown there is loss of interlock between cement and bone by resorption of trabeculae at the interface. The goal of this study was to determine if TKAs with more initial interlock between cement and bone would maintain more interlock with in vivo service (in the face of resorbing trabeculae) and have less micro-motion at the cement–bone interface. The initial (created at surgery) and current (after in vivo service) cement–bone interlock morphologies of sagittal implant sections from postmortem retrieved tibial tray constructs were measured. The implant sections were then functionally loaded in compression and the micro-motion across the cement–bone interface was quantified. Implant sections with less initial interdigitation between cement and bone and more time in service had less current cement–bone interdigitation (r²=0.86, p=0.0002). Implant sections with greater initial interdigitation also had less micro-motion after in vivo service (r²=0.36, p=0.0062). This work provides direct evidence that greater initial interlock between cement and bone in tibial components of TKA results in more stable constructs with less micro-motion with in vivo service.     

Porous surface modified bioactive bone cement for enhanced bone bonding

Background

Polymethylmethacrylate bone cement cannot provide an adhesive chemical bonding to form a stable cement-bone interface. Bioactive bone cements show bone bonding ability, but their clinical application is limited because bone resorption is observed after implantation. Porous polymethylmethacrylate can be achieved with the addition of carboxymethylcellulose, alginate and gelatin microparticles to promote bone ingrowth, but the mechanical properties are too low to be used in orthopedic applications. Bone ingrowth into cement could decrease the possibility of bone resorption and promote the formation of a stable interface. However, scarce literature is reported on bioactive bone cements that allow bone ingrowth. In this paper, we reported a porous surface modified bioactive bone cement with desired mechanical properties, which could allow for bone ingrowth.

Materials and Methods

The porous surface modified bioactive bone cement was evaluated to determine its handling characteristics, mechanical properties and behavior in a simulated body fluid. The in vitro cellular responses of the samples were also investigated in terms of cell attachment, proliferation, and osteoblastic differentiation. Furthermore, bone ingrowth was examined in a rabbit femoral condyle defect model by using micro-CT imaging and histological analysis. The strength of the implant–bone interface was also investigated by push-out tests.

Results

The modified bone cement with a low content of bioactive fillers resulted in proper handling characteristics and adequate mechanical properties, but slightly affected its bioactivity. Moreover, the degree of attachment, proliferation and osteogenic differentiation of preosteoblast cells was also increased. The results of the push-out test revealed that higher interfacial bonding strength was achieved with the modified bone cement because of the formation of the apatite layer and the osseointegration after implantation in the bony defect.

Conclusions

Our findings suggested a new bioactive bone cement for prosthetic fixation in total joint replacement.     

Primary stability of tibial plateaus under dynamic compression-shear loading in human tibiae – Influence of keel length,cementation area and tibial stem

The objective of our study was to evaluate the impact of the tibial keel & stem length in surface cementation, of a full cemented keel and of an additional tibial stem on the primary stability of a posterior stabilised tibial plateau (VEGA® System Aesculap Tuttlingen, Germany) under dynamic compression-shear loading conditions in human tibiae.We performed the cemented tibial plateau implantations on 24 fresh-frozen human tibiae of a mean donor age of 70.7 years (range 47–97). The tibiae were divided into four groups of matched pairs based on comparable trabecular bone mineral density. To assess the primary stability under dynamic compression shear conditions, a 3D migration analysis of the tibial component relative to the bone based on displacements and deformations and an evaluation of the cement layer including penetration was performed by CT-based 3D segmentation.Within the tested implant fixation principles the mean load to failure of a 28 mm keel and a 12 mm stem (40 mm) was 4700 ± 1149 N and of a 28 mm keel length was 4560 ± 1429 N (p = 0.996), whereas the mean load to failure was 4920 ± 691 N in full cementation (p = 0.986) and 5580 ± 502 N with additional stem (p = 0.537), with no significant differences regarding the dynamic primary stability under dynamic compression-shear test conditions.From our observations, we conclude that there is no significant difference between a 40 mm and a 28 mm tibial keel & stem length and also between a surface and a full cementation in the effect on the primary stability of a posterior stabilised tibial plateau, in terms of failure load, migration characteristics and cement layer thickness including the penetration into the trabecular bone.     

The influence of cement mantle thickness and stem geometry on fatigue damage in two different cemented hip femoral prostheses

Experimental models can be used for pre-clinical testing of cemented and other type of hip replacements. Total hip replacement (THR) failure scenarios include, among others, cement damage accumulation and the assessment of accurate stress and strain magnitudes at the cement mantle interfaces (stem-cement and cement-bone) can be used to predict mechanical failure. The aseptic loosening scenario in cemented hip replacements is currently not fully understood, and methods of evaluating medical devices must be developed to improve clinical performance. Different results and conclusions concerning the cement micro-cracking mechanism have been reported.The aim of this study was to verify the in vitro behavior of two cemented femoral stems with respect to fatigue crack formation. Fatigue crack damage was assessed at the medial, lateral, anterior and posterior sides of the Lubinus SPII and Charnley stems. All stems were loaded and tested in stair climbing fatigue loading during one million cycles at 2 Hz. After the experiments each implanted synthetic femur was sectioned and analyzed. We observed more damage (cracks per area) for the Lubinus SPII stem, mainly on the proximal part of the cement mantle. The micro-cracking formation initiated in the stem–cement interface and grew towards the direction of cortical bone of the femur.Overall, the cement–bone interface seems to be crucial for the success of the hip replacement. The Charnley stem provoked more damage on the cement–bone interface. A failure index (maximum length of crack/maximum thickness of cement) considered was higher for the cement–stem interface of the Lubinus SPII stem. For a cement mantle thickness higher than 5 mm, cracking initiated at the cement–bone interface and depended on the opening canal process (reaming procedure and instrumentation). The analysis also showed that fatigue-induced damage on the cement mantle, increasing proximally, and depended on the axial position of the stem. The cement thickness is an important factor for the success of THR and this study evidenced that cement thickness higher than 2 mm apparently does not affect the mechanical behavior of the cement mantel and induce more crack formation on the cement–bone interface.     

A Novel Injectable Borate Bioactive Glass Cement as an Antibiotic Delivery Vehicle for Treating Osteomyelitis

Background

A novel injectable cement composed of chitosan-bonded borate bioactive glass (BG) particles was evaluated as a carrier for local delivery of vancomycin in the treatment of osteomyelitis in a rabbit tibial model.

Materials and Methods

The setting time, injectability, and compressive strength of the borate BG cement, and the release profile of vancomycin from the cement were measured in vitro. The capacity of the vancomycin-loaded BG cement to eradicate methicillin-resistant Staphylococcus aureus (MRSA)-induced osteomyelitis in rabbit tibiae in vivo was evaluated and compared with that for a vancomycin-loaded calcium sulfate (CS) cement and for intravenous injection of vancomycin.

Results

The BG cement had an injectability of >90% during the first 3 minutes after mixing, hardened within 30 minutes and, after hardening, had a compressive strength of 18±2 MPa. Vancomycin was released from the BG cement into phosphate-buffered saline for up to 36 days, and the cumulative amount of vancomycin released was 86% of the amount initially loaded into the cement. In comparison, vancomycin was released from the CS cement for up 28 days and the cumulative amount released was 89%. Two months post-surgery, radiography and microbiological tests showed that the BG and CS cements had a better ability to eradicate osteomyelitis when compared to intravenous injection of vancomycin, but there was no significant difference between the BG and CS cements in eradicating the infection. Histological examination showed that the BG cement was biocompatible and had a good capacity for regenerating bone in the tibial defects.

Conclusions

These results indicate that borate BG cement is a promising material both as an injectable carrier for vancomycin in the eradication of osteomyelitis and as an osteoconductive matrix to regenerate bone after the infection is cured.     

The influence of tibial component fixation techniques on resorption of supporting bone stock after total knee replacement

Periprosthetic bone resorption after tibial prosthesis implantation remains a concern for long-term fixation performance. The fixation techniques may inherently aggravate the "stress-shielding" effect of the implant, leading to weakened bone foundation. In this study, two cemented tibial fixation cases (fully cemented and hybrid cementing with cement applied under the tibial tray leaving the stem uncemented) and three cementless cases relying on bony ingrowth (no, partial and fully ingrown) were modelled using the finite element method with a strain-adaptive remodelling theory incorporated to predict the change in the bone apparent density after prosthesis implantation. When the models were loaded with physiological knee joint loads, the predicted patterns of bone resorption correlated well with reported densitometry results. The modelling results showed that the firm anchorage fixation formed between the prosthesis and the bone for the fully cemented and fully ingrown cases greatly increased the amount of proximal bone resorption. Bone resorption in tibial fixations with a less secure anchorage (hybrid cementing, partial and no ingrowth) occurred at almost half the rate of the changes around the fixations with a firm anchorage. The results suggested that the hybrid cementing fixation or the cementless fixation with partial bony ingrowth (into the porous-coated prosthesis surface) is preferred for preserving proximal tibial bone stock, which should help to maintain post-operative fixation stability. Specifically, the hybrid cementing fixation induced the least amount of bone resorption.     

Residual stresses at the stem-cement interface of an idealized cemented hip stem

During the operation of total hip arthroplasty, when the cement polymerizes between the stem implant and the bone, residual stresses are generated in the cement. The purpose of this study was to determine whether including residual stresses at the stem-cement interface of cemented hip implants affected the cement stress distributions due to externally applied loads. An idealized cemented hip implant subjected to bending was numerically investigated for an early post-operative situation. The finite element analysis was three-dimensional and used non-linear contact elements to represent the debonded stem-cement interface. The results showed that the inclusion of the residual stresses at the interface had up to a 4-fold increase in the von Mises cement stresses compared to the case without residual stresses.     

Experimental method for the in vitro testing of the initial stability of cementless hip prostheses

Micromotions at the interface between bone and prosthesis are believed to induce bone resorption and ultimately lead to loosening of the implant. Thus the initial stability achieved by a hip prosthesis is an important factor for the long-term function of the implant. Knowing the biological consequences of the mechanical conditions, it appears to be mandatory to measure the extent of these three-dimensional movements. An in vitro dynamic method for measurement of the micromotion of the femoral component of hip prostheses has been developed. Tests in cemented prostheses have confirmed that the use of cement reduces sinkage and rotation manyfold and have yielded reference values for stability. Comparison with two types of cementless prostheses has shown that certain cementless implants may achieve stability comparable to cemented ones in some load directions.     

A modelling approach demonstrating micromechanical changes in the tibial cemented interface due to in vivo service

Post-operative changes in trabecular bone morphology at the cement-bone interface can vary depending on time in service. This study aims to investigate how micromotion and bone strains change at the tibial bone-cement interface before and after cementation. This work discusses whether the morphology of the post-mortem interface can be explained by studying changes in these mechanical quantities. Three post-mortem cement-bone interface specimens showing varying levels of bone resorption (minimal, extensive and intermediate) were selected for this study Using image segmentation techniques, masks of the post-mortem bone were dilated to fill up the mould spaces in the cement to obtain the immediately post-operative situation. Finite element (FE) models of the post-mortem and post-operative situation were created from these segmentation masks. Subsequent removal of the cement layer resulted in the pre-operative situation. FE micromotion and bone strains were analyzed for the interdigitated trabecular bone. For all specimens micromotion increased from the post-operative to the post-mortem models (distally, in specimen 1: 0.1 to 0.5 µm; specimen 2: 0.2 to 0.8 µm; specimen 3: 0.27 to 1.62 µm). Similarly bone strains were shown to increase from post-operative to post-mortem (distally, in specimen 1: −185 to −389 µε; specimen 2: −170 to −824 µε; specimen 3: −216 to −1024 µε). Post-mortem interdigitated bone was found to be strain shielded in comparison with supporting bone indicating that failure of bone would occur distal to the interface. These results indicate that stress shielding of interdigitated trabeculae is a plausible explanation for resorption patterns observed in post-mortem specimens.     

Influence of Nano-HA Coated Bone Collagen to Acrylic (Polymethylmethacrylate) Bone Cement on Mechanical Properties and Bioactivity

Objective

This research investigated the mechanical properties and bioactivity of polymethylmethacrylate (PMMA) bone cement after addition of the nano-hydroxyapatite(HA) coated bone collagen (mineralized collagen, MC).

Materials & Methods

The MC in different proportions were added to the PMMA bone cement to detect the compressive strength, compression modulus, coagulation properties and biosafety. The MC-PMMA was embedded into rabbits and co-cultured with MG 63 cells to exam bone tissue compatibility and gene expression of osteogenesis.

Results

15.0%(wt) impregnated MC-PMMA significantly lowered compressive modulus while little affected compressive strength and solidification. MC-PMMA bone cement was biologically safe and indicated excellent bone tissue compatibility. The bone-cement interface crosslinking was significantly higher in MC-PMMA than control after 6 months implantation in the femur of rabbits. The genes of osteogenesis exhibited significantly higher expression level in MC-PMMA.

Conclusions

MC-PMMA presented perfect mechanical properties, good biosafety and excellent biocompatibility with bone tissues, which has profoundly clinical values.     

Study of bone remodeling of two models of femoral cementless stems by means of DEXA and finite elements

Background  

A hip replacement with a cemented or cementless femoral stem produces an effect on the bone called adaptive remodelling, attributable to mechanical and biological factors. All of the cementless prostheses designs try to achieve an optimal load transfer in order to avoid stress-shielding, which produces an osteopenia.     

A subject-specific pelvic bone model and its application to cemented acetabular replacements

A subject-specific three-dimensional finite element (FE) pelvic bone model has been developed and applied to the study of bone–cement interfacial response in cemented acetabular replacements. The pelvic bone model was developed from CT scan images of a cadaveric pelvis and validated against the experiment data obtained from the same specimen at a simulated single-legged stance. The model was then implanted with a cemented acetabular cup at selected positions to simulate some typical implant conditions due to the misplacement of the cup as well as a standard cup condition. For comparison purposes, a simplified FE model with homogeneous trabecular bone material properties was also generated and similar implant conditions were examined.The results from the homogeneous model are found to underestimate significantly both the peak von Mises stress and the area of the highly stressed region in the cement near the bone–cement interface, compared with those from the subject-specific model. Non-uniform cement thickness and non-standard cup orientation seem to elevate the highly stressed region as well as the peak stress near the bone–cement interface.     

A new adhesive technique for internal fixation in midfacial surgery

Background  

The current surgical therapy of midfacial fractures involves internal fixation in which bone fragments are fixed in their anatomical positions with osteosynthesis plates and corresponding screws until bone healing is complete. This often causes new fractures to fragile bones while drilling pilot holes or trying to insert screws. The adhesive fixation of osteosynthesis plates using PMMA bone cement could offer a viable alternative for fixing the plates without screws. In order to achieve the adhesive bonding of bone cement to cortical bone in the viscerocranium, an amphiphilic bone bonding agent was created, analogous to the dentin bonding agents currently on the market.     

The effect of the interface on the bone stresses beneath tibial components

It was proposed that the stresses in the layer of bone immediately beneath a tibial component are an important determinant of fixation durability. Using finite element analysis, (ANSYS), the stresses were determined as a function of the amount of bone resection, the localization or completeness of implant-bone contact, and the interface material. The model was of two-dimensional sagittal slices consisting of quadrilateral elements (1 mm) with a range of seventeen material properties determined by CT scans. Typical prosthesis designs shifted the center of pressure more centrally rather than posteriorly, and thus increased anterior bone stresses. Resection up to 10 mm could actually decrease bone stresses due to an increase in bone surface area as long as complete coverage was obtained. A cement interface or direct metal on bone produced identical stresses. However a 1 mm complian: interface significantly reduced stresses in regions of high elastic modulus gradient. For rigid interfaces, the contact can be irregular, which leads to areas of over and understressing of bone. These conclusions have implications related to implant design.     

Application of <Emphasis Type="Italic">in vivo</Emphasis> micro-computed tomography in the temporal characterisation of subchondral bone architecture in a rat model of low-dose monosodium iodoacetate-induced osteoarthritis

Introduction  

Osteoarthritis (OA) is a complex, multifactorial joint disease affecting both the cartilage and the subchondral bone. Animal models of OA aid in the understanding of the pathogenesis of OA and testing suitable drugs for OA treatment. In this study we characterized the temporal changes in the tibial subchondral bone architecture in a rat model of low-dose monosodium iodoacetate (MIA)-induced OA using in vivo micro-computed tomography (CT).     

Fluid–structure interactions in micro-interlocked regions of the cement–bone interface

Experimental tests and computational modelling were used to explore the fluid dynamics at the trabeculae–cement interlock regions found in the tibial component of total knee replacements. A cement–bone construct of the proximal tibia was created to simulate the immediate post-operative condition. Gap distributions along nine trabeculae–cement regions ranged from 0 to 50.4 μm (mean = 12 μm). Micro-motions ranged from 0.56 to 4.7 μm with a 1 MPa compressive load to the cement. Fluid–structure analysis between the trabeculae and the cement used idealised models with parametric evaluation of loading direction, gap closing fraction (GCF), gap thickness, loading frequency and fluid viscosity. The highest fluid shear stresses (926 Pa) along the trabecular surface were found for conditions with very thin and large GCFs, much larger than reported physiological levels (～1–5 Pa). A second fluid–structure model was created with a provision for bone resorption using a constitutive model with resorption velocity proportional to fluid shear rate. A lower cut-off was used, below which bone resorption would not occur (50 s^? 1). Results showed that there was initially high shear rates (>1000 s^? 1) that diminished after initial trabecular resorption. Resorption continued in high shear rate regions, resulting in a final shape with bone left deep in the cement layer, and is consistent with morphology found in post-mortem retrievals. Small gaps between the trabecular surface and the cement in the immediate post-operative state produce fluid flow conditions that appear to be supra-physiologic; these may cause fluid-induced lysis of trabeculae in the micro-interlock regions.     

In vitro interface and cement mantle analysis of different femur stem designs

The aim of this study is to define stem design related factors causing both gaps in the metal-bone cement interface and cracks within the cement mantle. Six different stem designs (Exeter; Lubinus SP II; Ceraver Osteal; Mueller-straight stem; Centega; Spectron EF) (n=15 of each design) were cemented into artificial femur bones. Ten stems of each design were loaded, while five stems served as an unloaded control. Physiologically adapted cyclical loading (DIN ISO 7206-4) was performed with a hip simulator. After loading both interfaces and the bone cement itself were analysed regarding gaps and cracks in the cement mantle. Significant differences between the stem designs concerning gaps in the metal-bone cement interface and cracks in the cement mantle became apparent. Additionally, a high correlation between gaps in the metal-bone cement interface and cracks within the cement mantle could be proven. Gaps in the metal-bone cement interface but no cracks within the cement mantle were seen in the unloaded specimens. Differences between the unloaded control groups and the cyclical loaded stems regarding the longitudinal extension and width of gaps in the metal-bone cement interface were obvious. The designs of cemented femoral stems have an influence on both the quality of the metal-bone cement contact and the failure rate of the cement mantle. Less interface gaps and less cement defects were found with anatomically formed, collared, well-rounded stem designs without undercuttings.     

Automated image registration for assessing three-dimensional alignment of entire lower extremity and implant position using bi-plane radiography

An automated image-matching technique is presented to assess alignment of the entire lower extremity for normal and implanted knees and the positioning of implants with respect to bone. Sawbone femur and tibia and femoral and tibial components of a total knee arthroplasty system were used. Three spherical markers were attached to each sawbone and each component to define the local coordinate system. Outlines of the three-dimensional (3D) bone models and component computer-aided design (CAD) models were projected onto extracted contours of the femur, tibia, and implants in frontal and oblique X-ray images. Three-dimensional position of each model was recovered by minimizing the difference between the projected outline and the contour. Median values of the absolute error in estimating relative positions were within 0.5 mm and 0.6° for the femur with respect to the tibia, 0.5 mm and 0.5° for the femoral component with respect to the tibial component, 0.6 mm and 0.6° for the femoral component with respect to the femur, and 0.5 mm and 0.4° for the tibial component with respect to the tibia, indicating significant improvements when compared to manually obtained results.