Failure mechanism of the all-polyethylene glenoid implant

Fixation failure of glenoid components is the main cause of unsuccessful total shoulder arthroplasties. The characteristics of these failures are still not well understood, hence, attempts at improving the implant fixation are somewhat blind and the failure rate remains high. This lack of understanding is largely due to the fundamental problem that direct observations of failure are impossible as the fixation is inherently embedded within the bone.Twenty custom made implants, reflecting various common fixation designs, and a specimen set-up was prepared to enable direct observation of failure when the specimens were exposed to cyclic superior loads during laboratory experiments. Finite element analyses of the laboratory tests were also carried out to explain the observed failure scenarios.All implants, irrespective of the particular fixation design, failed at the implant–cement interface and failure initiated at the inferior part of the component fixation. Finite element analyses indicated that this failure scenario was caused by a weak and brittle implant–cement interface and tensile stresses in the inferior region possibly worsened by a stress raiser effect at the inferior rim.The results of this study indicate that glenoid failure can be delayed or prevented by improving the implant/cement interface strength. Also any design features that reduce the geometrical stress raiser and the inferior tensile stresses in general should delay implant loosening.     

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.     

Polymer composites for use in orthopedic surgery

Ever since Movin in (1950) and McKee in (1951) introduced the use of acrylic cement for fixation of hip prosthesis components a number of investigators have proposed various hip prosthesis designs using this cement fixation concept (Neale, 1967). This study was undertaken to support the hypothesis that certain dental materials could provide a more satisfactory bone-prosthesis bond than that presently possible with acrylic bone cement.^‡ Two restorative resins were found to have superior strength and resistance to thermal degradation when compared to acrylic bone cement. Tests of acrylic cement combined with apatite fillers suggest that restorative resin-anorganic bone composites would exhibit improved strength and toxicity properties and would also promote improved bonding due to resorption of the surface anorganic bone particles with subsequent bone infiltration and anchorage. Relatively high degradation of acrylic bone cement in accelerated aging tests suggests caution in using this material for implantation.     

Stress analysis of cemented glenoid prostheses in total shoulder arthroplasty

Glenoid component loosening is the most-frequently encountered problem in the total shoulder arthroplasty. The purpose of the study was to investigate whether failure of the glenoid component is caused by stresses generated within the cement mantle, implant materials and at the various interfaces during humeral abduction, using 3-D FE analyses of implanted glenoid structures. FE models, one total polyethylene and the other, metal backed polyethylene, were developed using CT-scan data and submodelling technique, which was based on an overall solution of a natural scapula model acted upon by all the muscles, ligaments and joint reaction forces. Material interfaces were assumed to be fully bonded. Based on the FE stress analysis, the following observations were made. (1) The submodelling technique, which required a large-size submodel and the use of prescribed displacements at cut-boundaries located far away from the glenoid, was crucial for evaluations on glenoid component. (2) Total polyethylene results in lower-peak stresses (tensile: 10 MPa, Von-Mises: 8.31 MPa) in the cement as compared to a metal-backed design (tensile: 11.5 MPa, Von-Mises: 9.81 MPa). The maximum principal (tensile) stresses generated in the cement mantle for both the designs were below its failure strength, but might evoke crack initiation. (3) The cement-bone interface adjacent to the tip of the keel seemed very likely to fail for both the designs. In case of metal-backed design, this interface adjacent to the tip of the keel appears even more likely to fail. (4) High metal-cement interface stresses for a moderate load might indicate failure at higher load. (5) It appears that both the designs were vulnerable to failure in some ways or the other. A part of the subchondral bone along the longitudinal axis of the glenoid cavity should be preserved to strengthen the glenoid structure and to reduce the use of cement.     

Adaptive glenoid bone remodeling simulation

Glenoid prosthesis loosening is the most common cause for revision total shoulder arthroplasty. Stress-induced bone remodeling may compromise long-term prosthesis fixation and significantly contribute to loosening. Realistic, robust analysis of bone-prosthesis constructs need to look beyond initial post-implantation mechanics provided by static finite element (FE) simulation. Adaptive bone remodeling simulations based on Wolff's law are needed for evaluating long-term glenoid prostheses fixation. The purpose of this study was to take a first step towards this goal and create and validate two-dimensional FE simulations, using the intact glenoid, for computing subject-specific adaptive glenoid remodeling. Two-dimensional glenoid FE models were created from scapulae computed tomography images. Two distinct processes, “element” and “node” simulations, used the forward-Euler method to compute bone remodeling. Initial bone density was homogeneous. Center and offset load combinations were iteratively applied. To validate the simulations we performed location-specific statistical comparisons between predicted and actual bone density, load combinations, and “element” and “node” processes. Visually and quantitatively “element” simulations produced better results (p>0.22), and correlation coefficients ranged 0.51–0.69 (p<0.001). Having met this initial work's goals, we expect subject-specific FE glenoid bone remodeling simulations together with static FE stress analyses to be effective tools for designing and evaluating glenoid prostheses.     

Acromion-fixation of glenoid components in total shoulder arthroplasty

Successful design of components for total shoulder arthroplasty has proven to be challenging. This is because of the difficulties in maintaining fixation of the component that inserts into the scapula; i.e., the glenoid component. Glenoid components that are fixated to both the glenoid and acromion (a long process extending medially on the dorsal aspect of the scapula) have the possible advantage of greater stability over those that are fixated to the glenoid alone. In this study, a finite element analysis is used to investigate whether or not acromion fixation is advantageous for glenoid components. Full muscle loading and joint reaction forces are included in the finite element model. Reflective photoelasticity of five scapulae is used to obtain experimental data to compare with results from the finite element analysis, and it confirms the structural behaviour of the finite element model. When implanted with an acromion-fixated prosthesis, it is found that high unphysiological stresses occur in the scapula bone, and that stresses in the fixation are not reduced. Very high stresses are predicted in that part of the prosthesis which connects the acromion to the glenoid. It is found that the very high stresses are partly in response to the muscle and joint reaction forces acting at the acromion. It is concluded that, because of the relatively high forces acting at the acromion, fixation to it may not be the way forward in glenoid component design.     

Use of an absorbable membrane to position biologically inductive materials in the periprosthetic space of cemented joints

A device is presented that positions ultrahigh molecular weight polyethylene (UHMWPE) debris against periprosthetic bone surfaces. This can facilitate the study of aseptic loosening associated with cemented joint prostheses by speeding the appearance of this debris within the periprosthetic space. The device, composed of a 100 microm thick bioabsorbable membrane impregnated with 1.4 x 10(9) sub-micron particles of UHMWPE debris, is positioned on the endosteum of the bone prior to the insertion of the cemented orthopedic implant. An in vitro pullout study and an in vivo canine pilot study were performed to investigate its potential to accelerate "time to aseptic loosening" of cemented prosthetic joints. Pullout studies characterized the influence of the membrane on initial implant fixation. The tensile stresses (mean+/-std.dev.) required to withdraw a prosthesis cemented into canine femurs with and without the membrane were 1.15+/-0.3 and 1.54+/-0.01 MPa, respectively; these findings were not significantly different (p > 0.4). The in vivo pilot study, involving five dogs, was performed to evaluate the efficacy of the debris to accelerate loosening in a canine cemented hip arthroplasty. Aseptic loosening and lameness occurred within 12 months, quicker than the 30 months reported in a retrospective clinical review of canine hip arthroplasty.     

Stress analysis and failure prediction in the proximal femur before and after total hip replacement

An investigation was performed to determine the effects of the presence of two lengths of proximal Müller prosthesis on predicted failure loads, as compared to those for an intact femur. Three-dimensional stresses in a bone/cement/prosthesis system were determined using finite element methods, with both isotropic and transversely isotropic material properties used for the diaphyseal cortex. Significant increases in prosthesis stem stresses were found when the transversely isotropic material properties were employed in the diaphyseal cortex. This leads to the conclusion that accurate anisotropic material properties for bone are essential for precise stress determination and optimum design in prosthetic implants. Failure loads were also predicted for vertical compression and axial torque, similar to available experimental conditions, and were within the range of the experimental failure data found in the literature. The technique developed herein can be used to systematically assess existing as well as future implant designs, taking into account the complex three-dimensional interaction effects of the overall bone/cement/prosthesis system.     

Effect of glenoid prosthesis design on glenoid bone remodeling: Adaptive finite element based simulation

Glenoid prosthesis loosening is the most common cause for revision total shoulder arthroplasty. Improved glenoid prosthesis design requires looking beyond initial post-implantation static stress analyses. Adaptive bone remodeling simulations based on Wolff’s law are needed for predicting long-term glenoid prosthesis results. This study demonstrates the capability of predicting glenoid bone remodeling produced by changing prosthesis design features. Twelve glenoid prostheses were designed to fit each of six donor human glenoids, using combinations of three peg types and four backing-peg material combinations (polyethylene and or metal). The twelve FE prosthesis models were individually combined, simulating surgical implantation, with the glenoid models. Remodeling simulations, using a validated adaptive bone remodeling simulation, commenced with homogeneous glenoid bone density. To produce bone remodeling, center, posterior-offset, and anterior-offset physiologic loads were consecutively applied to the bone–prosthesis FE models for 300 iterations. Upon completion, region-specific mean predicted bone apparent densities were compared between bone–prosthesis and intact glenoid FE models. Metal fixations significantly increased proximal-center bone density. Polyethylene fixations resulted in bone density approximately equal to intact. Two angled polyethylene peg designs with longer-anterior and shorter-posterior pegs, reflecting natural glenoid shape, best maintained mid and distal glenoid bone density. While these initial results were not validated, they demonstrate the capability and potential of adaptive glenoid bone remodeling simulation. We expect FE glenoid bone remodeling simulations to become powerful and robust tools in the design and evaluation of glenoid prostheses.     

Wear analysis in anatomical and reversed shoulder prostheses

This paper describes the development of a computational model to calculate wear rates in total shoulder prostheses, for a 5–150 degrees arm abduction. Anatomical keeled and pegged prosthesis as well as reversed prosthesis were the studied implants. The bone models were built based on computed tomography (CT) images and using a computer aided design-based modelling pipeline. The finite element method was used to solve the contact problem between the surface of the polyethylene (PE) components and the corresponding articular component. The aim of this work was to determine linear and volumetric PE wear, for several radial mismatches, in conditions of pathological (rheumatoid arthritis) and non-pathological bone. Results showed that contact pressures and linear wear developed in anatomical prosthesis were higher than those visualised in reversed prosthesis. However, anatomical prosthesis exhibited a better volumetric wear performance. Moreover, our findings indicated higher values of volumetric wear in higher congruent models and on pathological bone conditions.     

Wear analysis in anatomical and reversed shoulder prostheses

This paper describes the development of a computational model to calculate wear rates in total shoulder prostheses, for a 5-150 degrees arm abduction. Anatomical keeled and pegged prosthesis as well as reversed prosthesis were the studied implants. The bone models were built based on computed tomography (CT) images and using a computer aided design-based modelling pipeline. The finite element method was used to solve the contact problem between the surface of the polyethylene (PE) components and the corresponding articular component. The aim of this work was to determine linear and volumetric PE wear, for several radial mismatches, in conditions of pathological (rheumatoid arthritis) and non-pathological bone. Results showed that contact pressures and linear wear developed in anatomical prosthesis were higher than those visualised in reversed prosthesis. However, anatomical prosthesis exhibited a better volumetric wear performance. Moreover, our findings indicated higher values of volumetric wear in higher congruent models and on pathological bone conditions.     

Glenoid cancellous bone strength and modulus.

The objectives of this study were to determine the strength and modulus of glenoid cancellous bone, including regional variations. The motivations were: to select a suitable bone substitute for standardized testing of glenoid prosthesis loosening, to assist in shoulder prosthesis design and to provide input data for finite element analyses. Ten glenoids from eight cadavers (mean age, 81) were tested by in situ indentation. Mean strength ranged from 6.7 to 17 MPa for the ten glenoids, the overall mean being 10.3 MPa. Mean E moduli ranged from 67 to 171 MPa for the individual glenoids, the overall mean being 99 MPa. These values are likely at the lower end of what would be expected for normal bone since strength and modulus decrease with age and the available specimens were older. These values may be appropriate for prosthesis design, however, since mechanical properties are reduced in rheumatoid arthritic bone. Regional trends were very similar for modulus and strength. The strongest region was postero-superior. The central column, correlating with the keel position in many glenoid components, was weaker than both the anterior and posterior regions but deeper. A large drop in strength and modulus below the subchondral layer emphasizes the importance of maintaining this layer during prosthetic replacement.     

Finite element modelling of glenohumeral kinematics following total shoulder arthroplasty

Due to the shallowness of the glenohumeral joint, a challenging but essential requirement of a glenohumeral prosthesis is the prevention of joint dislocation. Weak glenoid bone stock and frequent dysfunction of the rotator cuff, both of which are common with rheumatoid arthritis, make it particularly difficult to achieve this design goal. Although a variety of prosthetic designs are commercially available only a few experimental studies have investigated the kinematics and dislocation characteristics of design variations. Analytical or numerical methods, which are predictive and more cost-effective, are, apart from simple rigid-body analyses, non-existent. The current investigation presents the results of a finite element analysis of the kinematics of a total shoulder joint validated using recently published experimental data for the same prostheses. The finite element model determined the loading required to dislocate the humeral head, and the corresponding translations, to within 4% of the experimental data. The finite element method compared dramatically better to the experimental data (mean difference=2.9%) than did rigid-body predictions (mean difference=37%). The goal of this study was to develop an accurate method that in future studies can be used for further investigations of the effect of design parameters on dislocation, particularly in the case of a dysfunctional rotator cuff. Inherently, the method also evaluates the glenoid fixation stresses in the relatively weak glenoid bone stock. Hence, design characteristics can be simultaneously optimised against dislocation as well as glenoid loosening.     

Finite element assessment of block-augmented total knee arthroplasty

Loosening and migration of tibial prostheses have been identified as causes of early total knee replacement (TKR) failure. The problem is made more complex when defects occur in the proximal tibia compromising fixation and alignment. Clinical studies using metal augments have shown these to be an alternative to other means of defect treatment. Finite element (FE) analysis can be used to identify regions that may be prone to loosening and migration. In the current work, 3D FE models of TKR uncontained type-2 defects treated with block augments have been constructed and analysed. It has been shown that a metal augment is the most suitable. The use of bone cement (PMMA) to fill proximal defects is not considered suitable as stresses carried by the cement block exceed those of the fatigue limit of bone cement. It has been shown that the stresses in the proximal cancellous bone of block-augmented models are significantly below levels likely to cause damage due to overloading. Furthermore, the use of stem extensions has been shown to reduce the cancellous bone stresses in the proximal region thus increasing the likelihood of bone resorption. Given this, it is recommended that stem extensions are not required unless necessary to mitigate some other problem.     

Improvement of mechanical properties of acrylic bone cement by fiber reinforcement

Acrylic bone cement is significantly weaker and less stiff than compact bone. Bone cement is also weaker in tension than in compression. This limits its use in orthopaedics to areas where tensile stresses are minimum. We have attempted to improve the mechanical properties of PMMA by reinforcing it with metal wires, and graphite and aramid fibers. Normal, carbon fiber reinforced and aramid fiber reinforced bone cement specimens were tested in compression. Addition of a small percentage (1-2% by weight for carbon and up to 6% for aramid) of these fibers improved the mechanical properties significantly. Due to the improved mechanical properties of fiber reinforced bone cement, its clinical use may reduce the incidence of cement fracture and thus loosening of the prosthesis.     

Bone ingrowth simulation for a concept glenoid component design

Glenoid component loosening is the major problem of total shoulder arthroplasty. It is possible that uncemented component may be able to achieve superior fixation relative to cemented component. One option for uncemented glenoid is to use porous tantalum backing. Bone ingrowth into the porous backing requires a degree of stability to be achieved directly post-operatively. This paper investigates the feasibility of bone ingrowth with respect to the influence of primary fixation, elastic properties of the backing and friction at the bone prosthesis interface. Finite element models of three glenoid components with different primary fixation configurations are created. Bone ingrowth into the porous backing is modelled based on the magnitude of the relative interface micromotions and mechanoregulation of the mesenchymal stem cells that migrated via the bonded part of the interface. Primary fixation had the most influence on bone ingrowth. The simulation showed that its major role was not to firmly interlock the prosthesis, but rather provide such a distribution of load, that would result in reduction of the peak interface micromotions. Should primary fixation be provided, friction has a secondary importance with respect to bone ingrowth while the influence of stiffness was counter intuitive: a less stiff backing material inhibits bone ingrowth by higher interface micromotions and stimulation of fibrous tissue formation within the backing.     

Design optimization of a prosthesis stem reinforcing shell in total hip arthroplasty

The use of a perforated, titanium funicular shell to support the proximal femoral cortex in total hip arthroplasty was evaluated with the aid of both analytical and numerical techniques. The principal interactions between the femoral cortex, the metal shell, the implant stem and the acrylic bone cement were modeled using beam on elastic foundations theory and two-dimensional elasticity theory. Subsequent formulation of this model as a nonlinear design optimization problem enabled the determination of the dimensions of the implant and reinforcing shell which minimized an objective function based on a simplified material failure criterion. Two cases were examined, each with two cervico-diaphyseal angles: case A: with a rigid contact between a proximal prosthesis collar and the calcar femorale and case B: no collar contact (a collarless prosthesis or post-operative loosening). Case A achieved an optimal solution at a stem diameter 11-23 percent of the cortex inner diameter, a stem length to diameter ratio of 12-40, shell diameter 22-53 percent and thickness 0.2-7.2 percent of the cortex inner diameter and thickness, respectively. Case B achieved an optimal solution at a stem diameter 67-92 percent of the cortex inner diameter, length to diameter ratio of 4-6, and no shell. In case A the collar support makes the type of internal fixation unimportant, while in the more realistic case B, the shell is not recommended.     

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.     

Bone remodelling of the scapula after a total shoulder arthroplasty

According to Wolff’s law, the changes in stress after a prosthesis implantation may modify the shape and internal structure of bone, thus compromising the long-term prosthesis fixation and, consequently, be a significant factor for glenoid loosening. The aim of the present study is to evaluate the changes in the bone adaptation process of the scapula after an anatomical and reverse total shoulder arthroplasty. Five finite element models of the implanted scapula are developed considering the implantation of three anatomical, cemented, all-polyethylene components; an anatomical, cementless, metal-backed component; and a reverse, all-metal component. The methodology followed to simulate the bone adaptation of the scapula was previously validated for the intact model, prior to the prosthesis implantation. Additionally, the influence of the bone quality on the adaptation process is also investigated by considering an osteoporotic condition. The results show that the stress shielding phenomenon is more concerning in cementless, metal-based components than in cemented, all-polyethylene components, regardless of the bone quality. Consequently, as far as the bone adaptation process of the bone is concerned, cemented, all-polyethylene components are better suited for the treatment of the shoulder joint.     

A three-dimensional non-linear finite element study of the effect of cement-prosthesis debonding in cemented femoral total hip components.

A three-dimensional non-linear finite element analysis of a cemented femoral component in which the component was partially debonded from the cement mantle was used to assess the effects of debonding on stresses in the cement. Three cases of partial cement-metal debonding were modelled with debonding of the proximal portion of the implant down to a horizontal plane which was 35, 62.5, or 82.5 mm below the prosthesis collar. Each situation was studied under loads simulating both gait and stairclimbing. Also, complete debonding between the implant and the surrounding cement mantle was modeled for loads simulating gait. Under stair climbing loads with partial cement-mental debonding, hoop stresses of 13-18 MPa were observed in the cement at the cement-metal interface at the proximal postero-medial corner of the implant. Similarly, in stair climbing, the maximum principal stresses in the cement were also adjacent to the proximal postero-medial region of the implant. These stresses were compressive and increased from 15 MPa with fully bonded interfaces to 48 MPa with debonding down to 82.5 mm below the prosthesis collar. Under gait loads, complete debonding caused high compressive stresses up to 34.9 MPa in the cement distal to the prosthesis tip. Thus, cement failure subsequent to prosthesis debonding is likely in the proximal region in a partially debonded implant due to stair climbing loads and is likely below the prosthesis tip in a fully debonded implant due to gait loading.