Measurement of transient and residual stresses during polymerization of bone cement for cemented hip implants

The initial fixation of a cemented hip implant relies on the strength of the interface between the stem, bone cement and adjacent bone. Bone cement is used as grouting material to fix the prosthesis to the bone. The curing process of bone cement is an exothermic reaction where bone cement undergoes volumetric changes that will generate transient stresses resulting in residual stresses once polymerization is completed. However, the precise magnitude of these stresses is still not well documented in the literature. The objective of this study is to develop an experiment for the direct measurement of the transient and residual radial stresses at the stem-cement interface generated during cement polymerization. The idealized femoral-cemented implant consists of a stem placed inside a hollow cylindrical bone filled with bone cement. A sub-miniature load cell is inserted inside the stem to make a direct measurement of the radial compressive forces at the stem-cement interface, which are then converted to radial stresses. A thermocouple measures the temperature evolution during the polymerization process. The results show the evolution of stress generation corresponding to volumetric changes in the cement. The effect of initial temperature of the stem and bone as well as the cement-bone interface condition (adhesion or no adhesion) on residual radial stresses is investigated. A maximum peak temperature of 70 degrees C corresponds to a peak in transient stress during cement curing. Maximum radial residual stresses of 0.6MPa in compression are measured for the preheated stem.     

Comparative in vitro study on the long term performance of cemented hip stems: validation of a protocol to discriminate between "good" and "bad" designs

The long-term clinical success of cemented hip stems is influenced both by the implant design, and by the surgical procedure. A methodology is proposed for discriminating between implant designs with different clinical outcomes. The protocol was designed with industrial pre-clinical validation in mind.Two cemented stem types were tested, one (Lubinus SPII) having good and the other (Müller Curved) having poor clinical outcomes. Three implants for each type were subjected to a mechanical in vitro test of one million loading cycles. Each cycle reproduced the load components of stair climbing. Interface shear micromotion was measured during the test in the direction of rotation and along the stem axis. The stem roughness before and after the test was compared. After the test, the cement mantles were retrieved and inspected through dye penetrants to detect evidences of micro-damage. For each specimen, the events of the loosening process were examined, based on the in vitro data available, so as to analyze the whole failure mechanism.The protocol developed was sensitive to the implant design, with significantly different results being found for the two stem types, both in terms of stem-cement micromotions, surface roughness alteration, and cement mantle damage. The information yielded by the three different investigation techniques was consistent for each of the two groups of specimens tested, allowing a better understanding of the failure process. In vitro inducible micromotion and permanent migration measurements, together with cement-stem interface fretting damage and cement fatigue damage, can help predicting the clinical performance of cemented stems.     

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.     

A Biomimetic Hip Joint Simulator and its Application in in vitro Study of the Integrity of Replacement Cemented Hip

1IntroductionAseptic loosening is a major clinical probleminterfering with long term success of arthroplasty inhumans.When this occurs,the stem will migrate withinthe cortical bone.The migration of the stem after hiparthroplasty is an unavoidable phenomenon and is one ofthe major cause of late aseptic loosening of the hiparthroplasty[1-5].Many factors,such as cement mantle performance,stem type and surface finish,cementing and surgerytechniques affect the subsidence or migration of thefemoral …     

Early cement damage around a femoral stem is concentrated at the cement/bone interface

This study aimed to improve understanding of the mechanical aspects of cemented implant loosening. After aggressive fatigue loading of stem/cement/femur constructs, micro-cracks and stem/bone micro-motions were quantified to answer three research questions: Are cracks preferentially associated with the stem/cement interface, the cement/bone interface or voids? Is cement damage dependent on axial position? Does cement damage correlate with micro-motion between the stem and the bone? Eight Charnley Cobra stems were implanted in cadaveric femora. Six stem/cement/femur constructs were subjected to "stair-climbing" loads for 300 kcycles at 2Hz. Loads were normalized by construct stiffness to avoid fracture. Two additional constructs were not loaded. Transverse sections were cut at 10mm intervals, stained with a fluorescent dye penetrant and examined using epi-fluorescence stereomicroscopy. Crack lengths and cement areas were recorded for 9 sections per specimen. Crack length-density was calculated by dividing summed crack length by cement mantle area. To isolate the effect of loading, length-density data were offset by the baseline length-density measured in the non-loaded specimens. Significantly more cracks were associated with the interdigitated area (35.1%+/-11.6%) and the cement/bone interface (31.0%+/-6.2%) than with the stem/cement interface (11.0%+/-5.2%) or voids (6.1%+/-4.8%) (p<0.05). Load-induced micro-crack length-density was significantly dependent on axial position, increasing proximally (p<0.001). Micro-motions were small, all stems rotated internally. Cement damage did not correlate with micro-motion.     

Challenges in relating experimental hip implant fixation predictions to clinical observations

Long-term clinical follow-up studies have shown that radiolucent lines at the cement interfaces of total hip replacement femoral components develop gradually, ultimately leading to loosening. In this experimental study, 32 synthetic femurs implanted with cemented femoral components were cyclically loaded with a dynamic joint reaction force, torque, and muscle force, to assess the relative effects of surface finish and collars on interface fixation. Four each of four otherwise identical straight femoral stems, varying only in surface finish and presence or lack of collars were used. Specimens were tested under two conditions: (1) with intact interfaces simulating immediate post-operative conditions and (2) with a thin-film at the stem-cement interface, simulating conditions several weeks to months post-operative when fibrous tissue has formed with the implant still stable. Micromotion was measured at both interfaces in three directions. Surface finish had a larger relative effect than collars, regardless of whether or not a thin-film was present. For example, a proximal grit-blasted finish enhanced fixation at the stem-cement interface by 7-12 μm per-cycle (p<0.05) and decreased early cement mantle loosening by 7-13 μm. For straight stems, rougher surfaces provided greater stability than polished, even with a thin film at the stem-cement interfaces, contradicting the theory that once debonded, rough stems are less stable than polished at the stem-cement interface. The findings of this experimental study exemplify the need to take advantage of all available tools for the preclinical evaluation of orthopaedic implants, including long-term clinical observations of related devices, analytical and numeric models, and experimental bench-top simulations.     

The effect of the density-modulus relationship selected to apply material properties in a finite element model of long bone

Material property assignment is a critical step in developing subject-specific finite element models of bone. Inhomogeneous material properties are often applied using an equation relating density and elastic modulus, with the density information coming from CT scans of the bone. Very few previous studies have investigated which density-elastic modulus relationships from the literature are most suitable for application in long bone. No such studies have been completed for the ulna. The purpose of this study was to investigate six such density-modulus relationships and compare the results to experimental strains from eight cadaveric ulnae. Subject-specific finite element models were developed for each bone using micro-CT scans. Six density-modulus equations were trialed in each bone, resulting in a total of 48 models. Data from a previously completed experimental study in which each bone was instrumented with twelve strain gauges were used for comparison. Although the relationship that best matched experimental strains was somewhat specimen and location dependent, there were two relations which consistently matched the experimental strains most closely. One of these under-estimated and one over-estimated the experimental strain values, by averages of 15% and 31%, respectively. The results of this study suggest that the ideal relationship for the ulna may lie somewhere in between these two relations.     

Finite element and experimental models of cemented hip joint reconstructions can produce similar bone and cement strains in pre-clinical tests

Finite element (FE) models could be used for pre-clinical testing of cemented hip replacement implants against the damage accumulation failure scenario. To accurately predict mechanical failure, the models should accurately predict stresses and strains. This should be the case for various implants. In the current study, two FE models of composite hip reconstructions with two different implants were validated relative to experimental bone and cement strains. The objective was an overall agreement within 10% between experimental and FE strains. Two stem types with different clinical results were analyzed: the Lubinus SPII and the Mueller Curved with loosening rates of 4% and 16% after 10 yr, respectively (Prognosis of total hip replacement. 63rd Annual Meeting of the American Academy of orthopaedic surgeons, Atlanta, USA). For both implant types, six stems were implanted in composite femurs. All specimens were subjected to bending. The Mueller Curved specimens were additionally subjected to torsion. Bone strains were recorded at 10 locations on the cortex and cement strains at three locations within the cement mantle. An FE model was built for both stem types and the experiments were simulated. Bone and cement strains were calculated at the experimental gauge locations. Most FE bone strains corresponded to the mean experimental strains within two standard deviations; most FE cement strains within one standard deviation. Linear regression between the FE and mean experimental strains produced slopes between 0.82 and 1.03, and R(2) values above 0.98. Particularly for the Mueller Curved, agreement improved considerably when FE strains were compared to the strains from the experimental specimen used to build the FE model. The objective of overall agreement within 10% was achieved, indicating that both FE models were successfully validated. This prerequisite for accurately predicting long-term failure has been satisfied.     

The effect of cross-sectional stem shape on the torsional stability of cemented implant components

Stability of a cemented implant, once the stem-cement interface has debonded, is reliant upon stem geometry and surface finish. There are relatively few studies addressing the effect of cross-sectional stem shape on cemented implant fixation. The purpose of this investigation was to compare the torsional stability of five different stem cross-sectional shapes-circular, oval, triangular, rectangular with rounded edges, and rectangular with sharp edges-under monotonically increasing and cyclic loading conditions. Seven samples of each stem geometry were tested. Stems were potted in bone cement and loaded to 5 deg of rotation. For monotonic loading, torque was applied at a constant rate of 2.5 deg/min. For cyclic loading, a sine wave torque pattern was applied, with a maximum magnitude that began at 4.5 Nm for 1500 cycles and then increased by 2.25 Nm every 1500 cycles until 5 deg of rotation. The rectangular stem with the sharp edges always provided the greatest resistance to torque, followed by the rectangular with rounded edges, triangular, oval, and circular. These results, including the effects of sharp corners, may differ for modes of loading other than torsion. These experimental results support the findings of earlier finite element models, indicating stem shape has a significant effect on resistance to torsional loading.     

Stem surface roughness alters creep induced subsidence and 'taper-lock' in a cemented femoral hip prosthesis

The clinical success of polished tapered stems has been widely reported in numerous long term studies. The mechanical environment that exists for polished tapered stems, however, is not fully understood. In this investigation, a collarless, tapered femoral total hip stem with an unsupported distal tip was evaluated using a 'physiological' three-dimensional (3D) finite element analysis. It was hypothesized that stem-cement interface friction, which alters the magnitude and orientation of the cement mantle stress, would subsequently influence stem 'taper-lock' and viscoelastic relaxation of bone cement stresses. The hypothesis that creep-induced subsidence would result in increases to stem-cement normal (radial) interface stresses was also examined. Utilizing a viscoelastic material model for the bone cement in the analysis, three different stem-cement interface conditions were considered: debonded stem with zero friction coefficient (mu=0) (frictionless), debonded stem with stem-cement interface friction (mu=0.22) ('smooth' or polished) and a completely bonded stem ('rough'). Stem roughness had a profound influence on cement mantle stress, stem subsidence and cement mantle stress relaxation over the 24-h test period. The frictionless and smooth tapered stems generated compressive normal stress at the stem-cement interface creating a mechanical environment indicative of 'taper-lock'. The normal stress increased with decreasing stem-cement interface friction but decreased proximally with time and stem subsidence. Stem subsidence also increased with decreasing stem-cement interface friction. We conclude that polished stems have a greater potential to develop 'taper-lock' fixation than do rough stems. However, subsidence is not an important determinant of the maintenance of 'taper-lock'. Rather subsidence is a function of stem-cement interface friction and bone cement creep.     

Design and implementation of an instrumented ulnar head prosthesis to measure loads in vitro

The development of a novel instrumented implant for ulnar head replacement is presented in this study. This implant was instrumented with strain gauges to quantify bending moments about the anatomic axes of the distal ulna, and subsequently the distal radioulnar joint (DRUJ) reaction force magnitude. The implant was surgically inserted in seven cadaveric upper extremities, which were subsequently mounted in a custom joint simulator. Simulated active unresisted pronation and supination motion trials were conducted using computer-controlled pneumatic actuators to simulate forearm musculature. Passive (unloaded) trials were also conducted. The reaction force across the DRUJ ranged from 2 to 10 N in magnitude during this unresisted motion. Increased bending moment magnitudes were measured when the forearm was positioned in supination compared to pronation. The magnitude of joint bending moments showed a consistent pattern with forearm position, regardless of simulated active or passive rotation, or supination and pronation motion trials. This result illustrates that the primary influence on joint load is likely the position and contact with the radial articulation. This study of DRUJ loading should be useful for biomechanical modeling, implant design considerations and improved knowledge of articular mechanics.     

Cortical bone viscoelasticity and fixation strength of press-fit femoral stems: finite element model

Many cementless implant designs rely upon a diaphyseal press-fit in conjunction with a porous coated implant surface to achieve primary or short term fixation, thereby constraining interface micromotion to such a level that bone ingrowth and consequent secondary or long-term fixation, i.e., osseointegration, can occur. Bone viscoelasticity, however, has been found to affect stem primary stability by reducing push-out load. In this investigation, an axisymmetric finite element model of a cylindrical stem and diaphyseal cortical bone section was created in order to parametrically evaluate the effect of bone viscoelasticity on stem push-out while controlling coefficient of friction (mu = 0.15, 0.40, and 1.00) and stem-bone diametral interference (delta = 0.01, 0.05, 0.10, and 0.50 mm). Based on results from a previous study, it was hypothesized that stem-bone interference (i.e., press-fit) would elicit a bone viscoelastic response which would reduce the initial fixation of the stem as measured by push-out load. Results indicate that for all examined combinations of mu and delta, bone viscoelastic behavior reduced the push-out load by a range of 2.6-82.6% due to stress relaxation of the bone. It was found that the push-out load increased with mu for each value of delta, but minimal increases in the push-out load (2.9-4.9%) were observed as delta was increased beyond 0.10 mm. Within the range of variables reported for this study, it was concluded that bone viscoelastic behavior, namely stress relaxation, has an asymptotic affect on stem contact pressure, which reduces stem push-out load. It was also found that higher levels of coefficient of friction are beneficial to primary fixation, and that an interference "threshold" exists beyond which no additional gains in push-out load are achieved.     

Influence of interface condition and implant design on bone remodelling and failure risk for the resurfaced femoral head

Resurfacing of the femur has experienced a revival, particularly in younger and more active patients. The implant is generally cemented onto the reamed trabecular bone and theoretical remodelling for this configuration, as well as uncemented variations, has been studied with relation to component positioning for the most common designs. The purpose of this study was to investigate the influence of different interface conditions, for alternative interior implant geometries, on bone strains in comparison to the native femur, and its consequent remodelling. A cylindrical interior geometry, two conical geometries and a spherical cortex-preserving design were compared with a standard implant (ASR, DePuy International, Ltd., UK), which has a 3° cone. Cemented as well as uncemented line to line and press-fit conditions were modelled for each geometry. A patient-specific finite element model of the proximal femur was used with simulated walking loads. Strain energy density was compared between the reference and resurfaced femur, and input into a remodelling algorithm to predict density changes post-operatively. The common cemented designs (cylindrical, slightly conical) had strain shielding in the superior femoral head (>35% reduction) as well as strain concentrations (strain>5%) in the neck regions near the implant rim. The cortex-preserving (spherical) and strongly conical designs showed less strain shielding. In contrast to the cemented implants, line to line implants showed a density decrease at the centre of the femoral head, while all press-fit versions showed a density increase (>100%) relative to the native femur, which suggests that uncemented press-fit implants could limit bone resorption.     

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.     

Mechanical analysis of a rodent segmental bone defect model: The effects of internal fixation and implant stiffness on load transfer

Segmental bone defect animal models are often used for evaluating the bone regeneration performance of bone substituting biomaterials. Since bone regeneration is dependent on mechanical loading, it is important to determine mechanical load transfer after stabilization of the defect and to study the effects of biomaterial stiffness on the transmitted load. In this study, we assess the mechanical load transmitted over a 6 mm femur defect that is stabilized with an internal PEEK fixation plate. Subsequently, three types of selective laser melted porous titanium implants with different stiffness values were used to graft the defect (five specimens per group). In one additional group, the defect was left empty. Micro strain gauges were used to measure strain values at four different locations of the fixation plate during external loading on the femoral head. The load sharing between the fixation plate and titanium implant was highly variable with standard deviations of measured strain values between 31 and 93% of the mean values. As a consequence, no significant differences were measured between the forces transmitted through the titanium implants with different elastic moduli. Only some non-significant trends were observed in the mean strain values that, consistent with the results of a previous finite element study, implied the force transmitted through the implant increases with the implant stiffness. The applied internal fixation method does not standardize mechanical loading over the defect to enable detecting small differences in bone regeneration performances of bone substituting biomaterials. In conclusion, the fixation method requires further optimization to reduce the effects of the operative procedure and make the mechanical loading more consistent and improve the overall sensitivity of this rat femur defect model.     

Central screw use delays implant dislodgement in osteopenic bone but not synthetic surrogates: A comparison of reverse total shoulder models

Adequate glenoid baseplate fixation in reverse total shoulder arthroplasty (rTSA) is important to achieve, but may prove challenging in the context of glenoid bone loss or osteopenia. Current rTSA testing standards rely upon synthetic bone surrogates, but it is unclear if these models accurately recapitulate the mechanics of osteoporotic bone. Additionally, it also unknown if the use of a central screw effectively provides resistance to micromotion in the milieu of poor quality bone. The purpose of this experiment was to create a novel cyclic load test protocol that elicited clinically relevant failures, so that comparisons of relative motion between baseplates and bones could be made with: (1) synthetic bones and poor quality cadaveric bones, and (2) the use or omission of a central screw. rTSA components were implanted into cadaveric and synthetic bones with and without a central screw. To model a range of loads that may be experienced during abduction, increasing cyclic loads were applied to shoulder joints in 30° of humeral abduction. Cycles and loads prior to permanent deformation exceeding 150 µm, 1 mm, and joint failure were determined using measurements from the test frame and from 3-D motion analysis. Synthetic bones demonstrated significantly more resistance to micromotion in comparison to cadaveric bones. Use of the central screw improved resistance to dislodgement, which was only observed in the cadaveric specimens. This study highlights the need for biomechanical testing with cadaveric specimens, especially when assessing osteopenic or osteoporotic populations.     

Evaluation of cement stresses in finite element analyses of cemented orthopaedic implants.

Stress analysis of the cement fixation of orthopaedic implants to bone is frequently carried out using finite element analysis. However the stress distribution in the cement layer is usually intricate, and it is difficult to report it in a way that facilitates comparison of implants for pre-clinical testing. To study this problem, and make recommendations for stress reporting, a finite element analysis of a hip prosthesis implanted into a synthetic composite femur is developed. Three cases are analyzed: a fully bonded implant, a debonded implant, and a debonded implant where the cement is removed distal to the stem tip. In addition to peak stresses, and contour and vector plots, a stressed volume and probability-of-failure analysis is reported. It is predicted that the peak stress is highest for the debonded stem, and that removal of the distal cement more than halves this peak stress. This would suggest that omission of the distal cement is good for polished prostheses (as practiced for the Exeter design). However, if the percentage of cement stressed above a certain threshold (say 3 MPa) is considered, then the removal of distal cement is shown to be disadvantageous because a higher volume of cement is stressed to above the threshold. Vector plots clearly demonstrate the different load transfer for bonded and debonded prostheses: A bonded stem generates maximum tensile stresses in the longitudinal direction, whereas a debonded stem generates most tensile stresses in the hoop direction, except near the tip where tensile longitudinal stresses occur due to subsidence of the stem. Removal of the cement distal to the tip allows greater subsidence but alleviates these large stresses at the tip, albeit at the expense of increased hoop stresses throughout the mantle. It is concluded that a thorough analysis of cemented implants should not report peak stress, which can be misleading, but rather stressed volume, and that vector plots should be reported if a precise analysis of the load transfer mechanism is required.     

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.     

Mechanical validation of whole bone composite tibia models

Composite synthetic models of the human tibia have recently become commercially available as substitutes for cadaveric specimens. Their use is justified by the advantages they offer as a substitute for real tibias. The present investigation concentrated on an extensive experimental validation of the mechanical behaviour of the whole bone composite model, compared to human specimens for different loading conditions. The stiffness of the tibias was measured with a torsional load applied along the long axis, and with a bending load applied both in the latero-medial and in the antero-posterior direction. The bending stiffness of the composite tibias matched well with that of the cadaveric specimens. This was not true for the torsional stiffness. In fact, the composite tibias were much stiffer than the cadaveric specimens, possibly due to the structure of the reinforcement material. The inter-specimen variability for the composite tibias was much lower than that for the cadaveric specimens. Thus, it seems that the composite tibias are suitable to replace cadaveric specimens for certain types of test, whereas they might be unsuitable for others, depending on the loading regimen.     

Improvement of femoral bone-cement adhesion in cemented revision hip arthroplasty by application of an amphiphilic bonder in a dynamic femur expulsion testing in vitro ]

Cemented femoral stems have shown decreased longevity compared to cementless implants in hip revision arthroplasty. The aim of this study was to evaluate the effect of an amphiphilic bonder on bone cement stability in a biomechanical femur expulsion test. A simplified hip simulator test setup with idealised femur stem specimens was carried out. The stems were implanted into bovine femurs (group 1: no bonder, n=10; group 2: bonder including glutaraldehyde, n=10; group 3: bonder without glutaraldehyde, n=10). A dynamic loading (maximum load: 800 N; minimum load: 100 N; frequency: 3 Hz; 105 cycles) was performed. Subsequently, the stem specimens were expulsed axially out of their implant beds and maximum load at failure was recorded. The static controls showed a mean maximum load to failure of 4123 N in group 1, 8357.5 N in group 2 and 5830.8 N in group 3. After dynamic loading, the specimens of group 2 reached the highest load to failure (8191.5 N), followed by group 3 (5649.5 N) and group 1 (3462 N), respectively. In group 2, we observed nine periprosthetic fractures at a load of 8400 N without signs of interface loosening. Application of an amphiphilic bonder led to a significant improvement of bonding stability, especially when glutaraldehyde was added to the bonder. This technique might offer an increased longevity of cemented femur revision stems in total hip replacement.