Polyetheretherketone (PEEK) has been proposed as an implant material for femoral total knee arthroplasty (TKA) components. Potential clinical advantages of PEEK over standard cobalt chrome alloys include modulus of elasticity and subsequently reduced stress shielding potentially eliminating osteolysis, thermal conduction properties allowing for a more natural soft tissue environment, and reduced weight enabling quicker quadriceps recovery. Manufacturing advantages include reduced manufacturing and sterilization time, lower cost, and improved quality control. Currently, no PEEK TKA implants exist on the market. Therefore, evaluation of mechanical properties in a pre-clinical phase is required to minimize patient risk. The objectives of this study include evaluation of implant fixation and determination of the potential for reduced stress shielding using the PEEK femoral TKA component. Experimental and computational analysis was performed to evaluate the biomechanical response of the femoral component (Freedom Knee, Maxx Orthopedics Inc., Plymouth Meeting, PA; Figure 1). Fixation strength of CoCr and PEEK components was evaluated in pull-off tests of cemented femoral components on cellular polyurethane foam blocks (Sawbones, Vashon Island, WA). Subsequent testing investigated the cemented fixation using cadaveric distal femurs. The reconstructions were subjected to 500,000 cycles of the peak load occurring during a standardized gait cycle (ISO 14243-1). The change from CoCr to PEEK on implant fixation was studied through computational analysis of stress distributions in the cement, implant, and the cement-implant interface. Reconstructions were analyzed when subjected to standardized gait and demanding squat loads. To investigate potentially reduced stress shielding when using a PEEK component, paired cadaveric femurs were used to measure local bone strains using digital image correlation (DIC). First, standardized gait load was applied, then the left and right femurs were implanted with CoCr and PEEK components, respectively, and subjected to the same load. To verify the validity of the computational methodology, the intact and reconstructed femurs were replicated in FEA models, based on CT scans.Introduction
Methods and Materials
PEEK-OPTIMA™ has been considered as an alternative to cobalt chrome in the femoral component of total knee replacements. Whole joint wear simulation studies of both the tibiofemoral and patellofemoral joints carried out to date have shown an equivalent wear rate of UHMWPE tibial and patella components against PEEK and cobalt chrome (CoCr) femoral components. In this study, the influence of third body wear on UHMWPE-on-PEEK was investigated, tests on UHMWPE-on-CoCr were carried out in parallel to compare PEEK to a conventional femoral component material. Wear simulation was carried out in simple geometry using a 6-station multi-directional pin-on-plate simulator. 5 scratches were created on each PEEK and CoCr plate perpendicular to the direction of the wear test using a diamond stylus to produce scratches with a geometry similar to that observed in retrieved CoCr femoral components. To investigate the influence of scratch lip height on wear, scratches of approximately 1, 2 and 4µm lip height were created. Wear simulation of GUR 1020 UHMWPE pins (conventional, non-sterile) against the plates was carried out for 1 million cycles (MC) using 17g/l bovine serum as a lubricant using kinematic conditions to replicate the average contact pressure and cross-shear in a total knee replacement. Wear of UHMWPE pins was measured gravimetrically and the surface topography of the plates assessed using a contacting Form Talysurf. Wear factors of the pins against the scratched plates were compared to unscratched controls (0µm lip height). Minimum n=3 for each condition and statistical analysis carried out using ANOVA with significance taken at p<0.05.Introduction
Methods
PEEK-OPTIMA™ has been considered as an alternative to cobalt chrome in the femoral component of total knee replacements. Wear simulation studies of both the tibiofemoral and patellofemoral joints carried out to date have shown an equivalent wear rate of UHMWPE tibial and patella components against PEEK and cobalt chrome (CoCr) femoral components implanted under optimal alignment conditions. In this study, fundamental pin-on-plate studies have been carried out to investigate the wear of UHMWPE-on-PEEK under a wider range of contact pressure and cross-shear conditions. The study was carried out in a 6 station multi-axial pin-on-plate reciprocating rig. UHMPWE pins (conventional, non- sterile) were articulated against PEEK-OPTIMA™ plates, initial Ra ∼0.02µm. The lubricant used was 25% bovine serum (17g/l) supplemented with 0.03% sodium azide. The contact pressure and cross-shear ratio conditions were selected to replicate those in total knee replacements and to be comparable to previously reported studies of UHMPWE-on-CoCr tested in the same pin-on-plate simulators. Contact pressures from 2.1 to 25.5MPa were created by changing the diameter of the contact face of the pin, the cross-shear ratios ranged from 0 (uniaxial motion) to 0.18. Wear of the UHMWPE pins was measured gravimetrically and the surface topography of the plates assessed using a contacting Form Talysurf. N=6 was carried out for each condition and statistical analysis carried out using ANOVA with significance taken at p<0.05.Introduction
Methods
PEEK-OPTIMA™ has been considered as an alternative bearing material to cobalt chrome in the femoral component of total knee replacements. To better understand the tribology of UHMWPE-on-PEEK-OPTIMA™ and to find the most appropriate environmental conditions under which to test this novel bearing material combination, a series of tests under different protein lubricant concentrations at rig (∼24°C) and elevated temperature (∼35°C) were carried out in simple geometry wear and friction rigs. Under all conditions, the wear of UHMWPE-on-PEEK-OPTIMA™ was compared to UHMWPE-on-cobalt chrome (CoCr). The pins used were GUR1020 UHMWPE (conventional, non-sterile) and the plate material was either polished CoCr (Ra<0.01µm) or PEEK-OPTIMA (Ra∼0.03µm) provided by Invibio Ltd, UK. The wear simulation was carried out in a six station reciprocating rig. The kinematic conditions were consistent for all tests and reflected the average cross shear and contact pressure (3.2MPa) in a total knee replacement. Tests were carried out at either rig running temperature (∼24°C) or at elevated temperature (∼35°C) and in varying protein lubricant concentrations (0, 2, 5, 25 and 90%). Wear of the UHMWPE pins was determined by gravimetric analysis. The pin-on-plate friction rig study was carried out at rig temperature in 0, 2, 5, 25 and 90% serum and reflected the contact pressure used in the wear tests. Measurements were taken using a piezoelectric sensor and the steady state friction derived. At least 3 repeats were taken for each study, statistical analysis carried out using ANOVA with significance taken at p<0.05.Introduction
Methods
Experimental wear simulation of an all-polymer knee implant has shown an equivalent rate of wear of UHMWPE tibial components against PEEK-OPTIMA™ and cobalt chrome femoral components of a similar initial geometry and surface topography. However, when the patella is resurfaced with an UHMWPE patella button, it is important to also ascertain the wear of the patella. Wear debris from the patella contributes to the total volume of wear debris produced by the implant which should be minimised to reduce the potential for osteolysis and subsequent implant loosening. The aim of this study was to investigate the wear of the patellofemoral joint in an all-polymer knee implant. The wear of UHMWPE patellae articulating against PEEK-OPTIMA™ femoral components was compared to UHMWPE articulating against cobalt chrome femoral components. Six mid-size (size C) PEEK-OPTIMA™ femoral components (Invibio Knee Ltd., UK) and six cobalt chrome femoral components of similar initial surface topography and geometry were coupled with 28mm all-polyethylene GUR1020 patellae (conventional, EO sterile) (Maxx Orthopaedics, USA). The implants were set up in a ProSim 6 station electromechanical knee simulator (Simulation Solutions, UK) which was modified for testing the patellofemoral joint. 3 million cycles (MC) of wear simulation was carried out under kinematics aiming to replicate a gait cycle adapted for an electromechanical simulator from previous work by Maiti et al. The simulator used has six degrees of freedom of which four were controlled; axial force up to 1200N, flexion/extension 22°, superior-inferior (SI) displacement (22mm) and Abduction-adduction (AA) (4°). The SI and AA were displacement controlled and driven through the patella. The medial-lateral displacement and tilt (internal/external rotation) of the patella were passive so the patella button was free to track the trochlear groove. The lubricant used was 25% bovine serum supplemented with 0.03% sodium azide to retard bacterial growth. The wear of patellae was determined gravimetrically with unloaded soak controls used to compensate for the uptake of moisture by the UHMWPE. The mean wear rate ± 95% confidence limits were calculated and statistical analysis was carried out using ANOVA with significance taken at p<0.05.Introduction
Materials and Methods
There is a demand for longer lasting arthroplasty implants driving the investigation of novel material combinations. PEEK has shown promise as an arthroplasty bearing material, with potentially relatively bio inert wear debris [1]. When coupled with an all-polyethylene tibial component this combination shows potential as a metal-free knee. In this study, the suitability of PEEK Optima® as an alternative to cobalt chrome for the femoral component of total knee replacements was assessed using experimental knee wear simulation under two kinematic conditions. Three cobalt chrome and three injection moulded PEEK Optima® (Invibio Biomaterial Solutions, UK) femoral components of similar geometry and surface roughness (mean surface roughness (Ra) ∼0.02µm) were coupled with all-polyethylene GUR1020 (conventional, unsterilised) tibial components in a 6 station ProSim knee simulator (Simulation Solutions, UK). 3 million cycles (MC) of wear simulation were carried out under intermediate kinematics (maximum anterior-posterior (AP) displacement 5mm) followed by 3MC under high kinematics (AP 10mm) [2] with 25% serum as the lubricant. The wear of the tibial component was assessed gravimetrically. At each measurement point, the surface roughness of the femoral components was determined using contacting profilometry and throughout testing, the bulk lubricant temperature was monitored close to the articulating surfaces. Statistical analysis was carried out using ANOVA, with significance at p<0.05.Introduction
Methods
A previous computational study on an all-polymer PEEK-on-UHMWPE total knee replacement implant showed improved periprosthetic bone loading, compared to a conventional implant [1]. That study used a simulated gait cycle to determine distal loading, but a patella was not included. Substantial distal decrease of bone remodeling stimulus was found, in accordance with previous reports [2], but it was not consistent with other clinical and post-mortem DEXA results, which found the largest loss of bone stock in the anterior region [3,4]. As patellofemoral forces are relatively low during gait compared to squatting, we simulated a deep squat, expecting that a high-demand activity would provide similar indications of bone loss as literature [3,4]. Consequently, we applied both high tibiofemoral and patellofemoral loads, to provide more insight in the potential benefits of a new PEEK-Optima® femoral component on periprosthetic bone stock. We adopted a deep squat finite element model from Zelle et al. and included quasi-static deep flexion and load sharing at the posterior condyles [6]. A new implant design was inserted, with three variations in material properties: intact, CoCr and PEEK. The stiffness of the femoral elements was mapped from CT and applied to either the cut femur only (CoCr and PEEK) or the entire femoral construct (intact). The strain energy density (SED) was evaluated in the periprosthetic region as a measure for bone remodeling stimulus. To examine the effects of the entire exercise, SED values were integrated over all increments.Introduction
Methods
UHMWPE articulating against PEEK-OPTIMA® has the potential for use as a novel bearing couple in joint arthroplasty due to its potentially low wear rates and the bioinertness of its wear debris. The aim of this study was to investigate the role of protein in the lubricant on the wear of UHMWPE articulating against PEEK at both room and physiological temperature. The wear of GUR1020 UHMWPE pins articulating against PEEK plates (Ra ∼0.06µm) was compared to highly polished cobalt chrome plates (Ra <0.01µm) in a 6-station multi-axial pin-on-plate rig using kinematics to replicate those in total knee arthroplasty. Tests were carried out at either ∼20°C or ∼36°C and wear was investigated under varying concentrations of bovine serum (0, 25 or 90%). Studies were carried out for 1 Million cycles with wear of the UHMWPE pins assessed gravimetrically using unloaded soak controls to compensate for moisture uptake. Statistical analysis was carried out using ANOVA with significance taken at p<0.05.Introduction
Methods
Periprosthetic bone remodelling after Total Knee Arthroplasty (TKA) may be attributed to local changes in the mechanical strain field of the bone as a result of the stiffness mismatch between high modulus metallic implant materials and the supporting bone. This can lead to significant loss of periprosthetic bone density, which may promote implant loosening, and complicate revision surgery. A novel polyetheretherketone (PEEK) implant with a modulus similar to bone has the potential to reduce stress shielding whilst eliminating metal ion release. Numerical modelling can estimate the remodelling stimulus but rigorous validation is required for use as a predictive tool. In this study, a finite element (FE) model investigating the local biomechanical changes with different TKA materials was verified experimentally using Digital Image Correlation (DIC). DIC is increasingly used in biomechanics for strain measurement on complex, heterogeneous anisotropic material structures. DIC was used following a previously validated technique [1] to compare bone surface strain distribution after implantation with a novel PEEK implant, to that induced by a contemporary metallic implant. Two distal Sawbone® femora models were implanted with a cemented cobalt-chromium (CoCr) and PEEK-OPTIMA® femoral component of the same size and geometry. A third, unimplanted, intact model was used as a reference. All models were subjected to standing loads on the corresponding UHMWPE tibial component, and resultant strain data was acquired in six repeated tests. An FE model of each case, using a CT-derived bone model, was solved using ANSYS software.Introduction
Methodology
Conventional implant designs in total knee arthroplasty (TKA) are based on metal on UHMWPE bearing couples. Although this procedure is quite successful, early loosening is still a matter of concern. One of the causes for early failure is stress shielding, leading to loss of bone stock, periprosthetic bone fractures and eventually aseptic loosening of the component. The introduction of a polyetheretherketone (PEEK) on UHMWPE bearing couple could address this problem. With mechanical properties more similar to distal (cortical) bone it could allow stresses to be distributed more naturally in the distal femur. A potential adverse effect, however, is that the femoral component and the underlying cement mantle may be at risk of fracturing. Therefore, we analyzed the effect of a PEEK-Optima® femoral component on stress shielding and the integrity of the component and cement mantle, compared to a conventional Cobalt-Chromium (CoCr) alloy implant. We created a Finite Element (FE) model of a reconstructed knee in gait, based on the ISO-14243-1 standard. The model consisted of an existing cemented cruciate retaining TKA design implanted on a distal femur, and a tibial load applicator, which together with the bone cement layer and the tibial implant is referred to as the tibial construct. The knee flexion angle was controlled by the femoral construct, consisting of the femoral implant, the bone cement and the distal femur. The tibial construct was loaded with an axial force, anterior-posterior (AP) force and a rotational torque, representing the ground reaction force, soft tissue constraints and internal/external rotation of the tibia, respectively. The integrity of the femoral component and cement mantle were expressed as a percentage of their yield stress. Stress shielding in the periprosthetic femur was evaluated by the strain energy (density) in the bone and compared to a model replicating an intact knee joint.Introduction
Methods
Current clinical practice in total knee arthroplasty (TKA) is largely based on metal on polyethylene bearing couples. A potential adverse effect of the stiff metal femoral component is stress shielding, leading to loss of bone stock, periprosthetic bone fractures and eventually aseptic loosening of the component. The use of a polymer femoral component may address this problem. However, a more flexible material may also have consequences for the fixation of the femoral component. Concerns are raised about its expected potential to introduce local stress peaks on the interface. The objective of this study was to analyze the effect of using a polyether-etherketone (PEEK-Optima®) femoral component on the cement-implant interface. We analyzed the interface stress distribution occurring during normal gait, and compared this to results of a standard CoCr component. An FEA model was created, consisting of a femoral component cemented onto a femur, and a polyethylene tibial component. A standard loading regime was applied mimicking an adapted gait cycle, according to ISO14243-1. The implant-cement interface was modelled as a zero-thickness layer connecting the implant to the cement layer. Femoral flexion/extension was prescribed for the femur in a displacement controlled manner, while the joint loads were applied to pivoting nodes attached to the tibial construct, consistent with the ISO standard. Implant-cement interface properties were adopted from a previous study on CoCr interface debonding[1].Introduction
Materials and methods
Impaction bone grafting with milled human allograft is the gold standard for replacing lost bone stock during revision hip surgery. Problems surrounding the use of allograft include cost, availability, disease transmission and stem subsidence (usually due to shear failure of the surrounding allograft). Aims. To investigate various polymers for use as substitute allograft. The ideal graft would be a composite with similar mechanical characteristics as allograft, and with the ability to form de novo bone. High and low molecular weight (MW) forms of three different polymers (polylactic acid (PLA), poly (lactic-co-glycolic) acid (PLGA) and polycaprolactone (PCL)) were milled, impacted into discs, and then tested in a custom built shear testing rig, and compared to allograft. A second stage of the experiment involved the addition of skeletal stem cells (SSC) to each of the milled polymers, impaction, 8 days incubation, and then tests for cell viability and number, via fluorostaining and biochemical (WST-1, DNA) assays.Background
Methods
Skeletal stem cells (SSCs) have been used for the treatment of osteonecrosis of the femoral head to prevent subsequent collapse. In isolation SSCs do not provide structural support but an innovative case series in Southampton, UK, has used SSCs in combination with impaction bone grafting (IBG) to improve both the biological and mechanical environment and to regenerate new bone at the necrotic site. Analysis of retrieved tissue-engineered bone as part of ongoing follow-up of this translational case series.Background
Aims
Disease transmission, availability and economic costs of allograft have resulted in significant efforts into finding an allograft alternative for use in impaction bone grafting (IBG). Biotechnology offers the combination of skeletal stem cells (SSC) with biodegradable polymers as a potential solution. Recently polymers have been identified with both structural strength and SSC compatibility that offer the potential for clinical translation. The aim of this study was to assess whether increasing the porosity of one such polymer via super critical CO2 fluid foaming (SCF) enhanced the mechanical and cellular compatibility characteristics for use as an osteogenic alternative to allograft in IBG. High molecular weight PLA scaffolds were produced via traditional (solid block) and SCF (porous) techniques, and the differences characterised using scanning electron microscopy (SEM). The polymers were milled, impacted, and mechanical comparison between traditional vs SCD created scaffolds and allograft controls was made using a custom shear testing rig, as well as a novel agitation test to assess cohesion. Cellular compatibility tests for cell number, viability and osteogenic differentiation using WST-1 assays, fluorostaining and ALP assays were determined following 14 day culture with SSC's.Aims
Methods
Impaction bone grafting with milled human allograft is the gold standard for replacing lost bone stock during revision hip surgery. Problems surrounding the use of allograft include cost, availability, disease transmission and stem subsidence (usually due to shear failure of the surrounding allograft). The aim of this study was to investigate various polymers for use as substitute allograft. The ideal graft would be a composite with similar mechanical characteristics as allograft, and with the ability to form High and low molecular weight (MW) forms of three different polymers (polylactic acid (PLA), poly (lactic co-glycolic) acid (PLGA) and polycaprolactone (PCL)) were milled, impacted into discs, and then tested in a custom built shear testing rig, and compared to allograft. A second stage of the experiment involved the addition of skeletal stem cells (SSC) to each of the milled polymers, impaction, 8 days incubation, and then tests for cell viability and number, via fluorostaining and biochemical (WST-1) assays.Aims
Methods
Patients suffering from finger joint pain or dysfunction due to arthritis and traumatic injury may require arthroplasty and joint replacement. Single-part silicone-based implants remain the material of choice and most widely used option, although reports on their long-term clinical performance are variable. For trauma indications, patients have a high expectation of functionality necessitating the use of materials with high wear resistance and mechanical performance. A new proximal inter phalangeal (PIP) joint designed by Zrinski AG (Wurmlingen, Germany), comprising a self-mating carbon fibre reinforced polyetheretherketone (CFR-PEEK) coupling, may provide a suitable alternative. Here we describe the wear performance of the CFR-PEEK components in a PIP joint wear simulator and subsequent characterisation of the wear particles. Four proximal and distal PIP components were milled (Zrinski AG) from CFR-PEEK (Invibio Ltd, UK) and subjected to wear testing (Endo Lab ® GmbH, Germany). The test was conducted at 37°C over 5 million cycles in 25% bovine serum (refreshed every 0.5 million cycles). The load was a static force of 63N applied at a frequency of 1Hz with a flexion/extension angle of ±40°. Wear rate was determined by mass loss from each component. Pooled serum samples from the wear simulator were subjected to protein digest and the remaining particulate debris isolated by serial filtration through 10μm, 1μm and 0.1μm filters. Particle size and morphology was subsequently determined by scanning electron microscopy (SEM) (Continuum Blue, UK).Introduction
Methods
Skeletal stem cells can be combined with human allograft, and impacted to produce a mechanically stable living bone composite. This strategy has been used for the treatment of femoral head avascular necrosis, and has been translated to four patients, of which three remain asymptomatic at up to three year follow-up. In one patient collapse occurred in both hips due to widely distributed and advanced AVN disease, necessitating bilateral hip arthroplasty. However this has provided the opportunity to retrieve the femoral heads and analyse human tissue engineered bone. Analysis of retrieved human tissue-engineered bone in conjunction with clinical follow-up of this translational case series.Background
Aims
Disease transmission, availability and economic costs of allograft have resulted in significant efforts into finding an allograft alternative for use in impaction bone grafting (IBG). Biotechnology offers the combination of skeletal stem cells (SSC) with biodegradable polymers as a potential solution. Recently polymers have been identified with both structural strength and SSC compatibility that offer the potential for clinical translation. The aim of this study was to assess whether increasing the porosity of one such polymer via super critical CO2 dissolution (SCD) enhanced the mechanical and cellular compatibility characteristics for use as an osteogenic alternative to allograft in IBG. High molecular weight PLA scaffolds were produced via traditional (solid block) and SCD (porous) techniques, and the differences characterised using scanning electron microscopy (SEM). The polymers were milled, impacted, and mechanical comparison between traditional vs SCD created scaffolds and allograft controls was made using a custom shear testing rig, as well as a novel agitation test to assess cohesion. Cellular compatibility tests for cell number, viability and osteogenic differentiation using WST-1 assays, fluorostaining and ALP assays were determined following 14 day culture with SSCs. SEM showed increased porosity of the SCD produced PLA scaffolds, with pores between 50-100 micrometres. Shear testing showed the SCD polymer exceeded the shear strength of allograft controls (P<0.001). Agitation testing showed greater cohesion between the particles of the SCD polymer (P<0.05). Cellular studies showed increased cell number, viability and osteogenic differentiation on the SCD polymer compared to traditional polymer (P<0.05) and allograft (P<0.001). The use of supercritical C02 to generate PLA scaffolds significantly improves the cellular compatibility and cohesion compared to traditional non-porous PLA, without substantial loss of mechanical shear strength. The improved characteristics are critical for clinical translation as a potential osteogenic composite for use in impaction bone grafting.
Impaction bone grafting with milled human allograft is the gold standard for replacing lost bone stock during revision hip surgery. Problems surrounding the use of allograft include cost, availability, disease transmission and stem subsidence (usually due to shear failure of the surrounding allograft). The aim of this study was to investigate various polymers for use as substitute allograft. The ideal graft would be a composite with similar mechanical characteristics as allograft, and with the ability to form de novo bone. High and low molecular weight (MW) forms of three different polymers (polylactic acid (PLA), poly (lactic co-glycolic) acid (PLGA) and polycaprolactone (PCL)) were milled, impacted into discs, and then tested in a custom built shear testing rig, and compared to allograft. A second stage of the experiment involved the addition of skeletal stem cells (SSC) to each of the milled polymers, impaction, 8 days incubation, and then tests for cell viability and number, via fluorostaining and biochemical (WST-1) assays. The shear strengths of both high/ low MW PLA, and high/low MW PLGA were significantly higher than those of milled allograft (P<0.001, P<0.001, P<0.005 and P<0.005) but high and low MW PCL was poor to impact, and had significantly lower shear strengths (P<0.005, P<0.001). Fluorostaining showed good cell survival on high MW PLA, high MW PCL and high MW PLGA. These findings were confirmed with WST-1 assays. High MW PLA as well as high MW PLGA performed well both in mechanical testing and cell compatibility studies. These two polymers are good contenders to produce a living composite for use as substitute human allograft in impaction bone grafting, and are currently being optimised for this use via the investigation of different production techniques and in-vivo studies.
