Wear debris induced osteolysis and loosening continue to be causes of clinical failure in total knee replacement (TKR). Laboratory simulation aims to predict the wear of TKR bearings under specific loading and motion conditions. However, the conditions applied may have significant influence on the study outcomes (1) The aim of this study was to examine the influence of femoral setup and kinematic inputs on the wear of a conventional polyethylene fixed bearing TKR through experimental and computational models. Six right Sigma CR fixed bearing TKRs (DePuy Synthes, Leeds, UK) with curved polyethylene inserts (GVF, GUR1020 UHMWPE) were tested in Prosim knee simulator (Simulator Solutions, UK). The femoral bearing was set up with the centre of rotation (CoR) on either on the distal radius of the implant (Distal CoR), as indicated by the device design, or according to the ISO specification (ISO CoR; ISO14243-3). The tests were conducted under ‘High Kinematics’ (2). It was necessary to reverse the direction of the anterior-posterior displacement for the tests conducted with the ISO centre of rotation to maintain the contact region within the insert surface (Reverse High Kinematics). Tests were conducted for three million cycles, lubricated with 25% bovine serum, with wear assessed gravimetrically. The computational wear model for the TKR was based on the contact area and an independent experimentally determined non-dimensional wear coefficient, previously validated against the experimental data (3).Introduction
Methods
Patella femoral joint bearings in total knee replacements have shown low wear (3.1 mm3/MC) under standard gait simulator conditions1. However, the wear in retrieval studies have shown large variations between 1.3 to 45.2 mm3/year2. Previous in vitro studies on the tibial femoral joint have shown wear is dependent on design, materials and kinematics3. The aim of this study was to investigate the influence of the design (geometry) and shape on the wear rate of patella femoral joints in total knee replacements. The Leeds/Prosim knee simulator was used to investigate the wear of two types of commercially available patellae. The PFC Sigma cobalt chrome femoral component was coupled with 2 types of patellae buttons: round and oval dome. The UHMWPE was the same for the both types – GUR1020 GVF (gamma irradiated in vacuum and foiled packed). 25% bovine serum was used as the lubricant. The test were carried out at three conditions – high medial lateral (ML) rotations (<4°) and uncontrolled ML displacement (<4 mm), low ML rotation (<1°) and uncontrolled ML displacement (<4 mm); the physiological gait cycle; and low ML rotation and controlled ML displacement (<1.5 mm). In this abstract the two designs were tested in physiological gait condition (Figure 1). Patella ML displacement and tilt were passively controlled and measured after every 300,000 cycles. A ligament resisting force equivalent to 10 N4 was applied on the lateral side of the patella to avoid patella slip. Five samples of each design were tested for 3 million cycles at a cycle rate of 1 Hz. The wear volume was obtained gravimetrically every million cycles and presented with 95% confidence limits. Statistical significance was taken at p<0.05.Introduction
Materials and Methods
Wear of polyethylene continues to be a significant factor in the longevity of total knee replacement (TKR). Moderately cross-linked polyethylene has been employed to reduce the wear of knee prostheses, and more recently anti-oxidants have been introduced to improve the long-term stability of the polyethylene material. This is the initial study of the wear of a new anti-oxidant polyethylene and a new TKR design, which has modified femoral condylar geometry. The wear of a new TKR the Attune knee was investigated using a physiological six station Prosim knee wear simulator (Simulator Solutions, UK). Six mid-size Attune fixed bearing cruciate retaining TKRs (DePuy Inc, Warsaw, USA) were tested for a period of 6 million cycles. The inserts were manufactured from AOX™, a compression moulded GUR1020 polyethylene incorporating Covernox™ solid anti-oxidant. The AOX polymer was irradiated to 8M Rad, to give a moderately cross-linked material. High and intermediate kinematics, under anterior-posterior displacement control were used for this study (McEwen Introduction
Materials and Methods
Ceramic-on-metal hip replacements (COM, where the head is a Biolox Delta ceramic and liner is Co Cr alloy), have demonstrated reduced wear under standard conditions in vitro compared to metal-on-metal (MOM) [1]. Early clinical results are also encouraging [2]. Recently concerns have been raised regarding the poor clinical performance of MOM hip resurfacings [3], particularly when cups are steeply inclined. Laboratory hip simulator testing has been used to replicate edge loading, also demonstrating elevated wear [4]. Therefore, a range of conditions to replicate sub-optimal use clinically to better predict in vivo performance should be used. The aim of this study was to compare the wear rates of MOM and COM under adverse edge loading conditions in an in vitro hip simulator test. Ceramic-on-metal (n=3) and metal-on-metal (n=3) 36mm hip prostheses (supplied by DePuy International Ltd, UK) were tested in the Leeds Physiological Anatomical Hip Joint Simulator. Liners were mounted to provide a clinical angle of 45o, and stems positioned anatomically. A simplified gait cycle and microseparation was applied as previously described [5] for two million cycles in 25% new born calf serum. Gravimetric analysis was completed every million cycles and wear volumes calculated.INTRODUCTION
METHODS
Concerns regarding UHMWPE wear particle induced osteolysis in total hip replacement (THR, [1]) have led to alternative materials to be sought. Carbon-fibre reinforced poly-ether-ether-ketone (CFR-PEEK) has shown reduced wear in hip and knee configurations compared with conventional polyethylene [2-4]. The aim of this study was to investigate the wear performance of a ceramic-on-CFR PEEK THR through a simulator study. Five 36mm diameter Biolox Delta heads were paired with extruded CFR-PEEK cups and tested in a hip wear simulator (Simulator Solutions, UK) for 10 million cycles (Mc). Tests were performed in a Prosim hip simulator, which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of −15 to +30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted anatomically. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide. Wear was assessed gravimetrically at several intervals adjusted for moisture uptake using loaded and unloaded soak controls.Introduction
Methodology
Ceramic-on-ceramic hip replacements have generated great interest in recent years due to substantial improvements in manufacturing techniques and material properties1. Microseparation conditions that could occur due to several clinical factors such as head offset deficiency, medialised cup combined with laxity of soft tissue resulting in a translation malalignment, have been shown to cause edge loading, replicate clinically relevant wear mechanisms2,3 and increase the wear of ceramic-on-ceramic bearings3,4. The aim of this study was to investigate the influence of increasing the femoral head size on the wear of ceramic-on-ceramic bearings under several clinically relevant simulator conditions. The wear of size 28mm and 36mm ceramic-on-ceramic bearings (BIOLOX® INTRODUCTION
MATERIALS AND METHODS
Hip wear simulation is a widely used technique for the pre-clinical evaluation of new bearing designs. However, wear rates seen in vitro can often be significantly different to those seen clinically. This can be attributed to the difference between the optimal conditions in a simulator and wide ranging conditions in real patients. This study aimed to develop more clinically relevant simulator tests, looking specifically at the effects of cup inclination angle (in vivo) and stop-dwell-start (SDS) protocols on a clinically available product. Five tests using a Paul type walking cycle (ISO 14242) were carried out on two ProSim hip simulators:
28mm MoM, standard walking, cup inclination 45°, (n = 5) 36mm MoM, standard walking, cup 45°, (n = 4) 36mm MOM, SDS: 10 walking cycles and pause of 5s with stance load of 1250N cup 45°, (n = 5) 36mm MOM, SDS: 10 walking cycles and pause of 30s with stance load of 1250N, (n = 5) cup 45° 36mm MOM, standard walking, cup 55°(n = 5), and 65°(n = 5). All samples had matched clearances, measured using a CMM (Prismo Navigator, Zeiss, Germany). Wear was measured gravimetrically (Sartorius ME235S: 0.01mg).Introduction
Method
Retrieval and clinical studies of metal-on-metal (MoM) bearings have associated increased wear1 and elevated patient ion levels2 with steep cup inclination angles and edge loading conditions. The University of Leeds have previously developed a hip simulator method that has been validated against retrievals and shown to replicate clinically relevant wear rates and wear mechanisms3,4. This method involves introducing lateral microseparation to represent adverse joint laxity and offset deficiency. This study aimed to investigate the effect of microseparation representing translational malpostion, and increased cup inclination angle, representing rotational malposition, in isolation and combined on the wear of different sizes (28 and 36mm) MoM bearing in total hip replacement (THRs). The wear of size 28mm and 36mm MoM THRs bearings was determined under different INTRODUCTION
MATERIALS AND METHODS
In vitro the introduction of microseparation and edge loading to hip simulator gait cycle has replicated clinically relevant wear rates and wear mechanisms in ceramic-on-ceramic bearings[1], and elevated the wear rates of MoM surface replacements (SR) to levels similar to those observed in retrievals[2]. The aim was to assess the wear of two different sized MoM total hip replacement bearings under steep cup inclination angles and adverse microseparation and edge loading conditions. Two tests were performed on the Leeds II hip joint simulator using two different size bearings (28mm and 36mm). Cups were mounted to provide inclination angles of 45 degrees (n=3) and 65 degrees (n=3). The first three million cycles were under standard gait conditions. Microseparation and edge loading conditions as described by Nevelos et al[1] were introduced to the gait cycle for the subsequent three million cycles. The lubricant was 25% new born calf serum. The mean wear rates and 95% confidence limits were determined and statistical analysis was performed using One Way ANOVA. Under standard gait conditions, when the cup inclination angle increased from 45 degrees to 65 degrees, the wear of size 28mm bearing significantly (p=0.004) increased by 2.7-fold, however, the larger bearings did not show any increase in wear (p=0.9). The introduction of microseparation conditions resulted in a significant (p=0.0001) increase in wear rates for both bearing sizes under both cup inclination angle conditions. Under microseparation conditions, the increase in cup inclination angle had no influence on the wear rate for both bearing sizes (Figure 1). With larger bearings, head-rim contact occurs at a steeper cup inclination angle providing an advantage over smaller bearings. The introduction of edge loading and microseparation conditions resulted in a significant increase in wear rates for both bearing sizes. The wear rates obtained in this study under combined increased cup inclination angle and microseparation were half of those obtained when SR MoM bearings were tested under similar adverse conditions[2]. This study shows the importance of prosthesis design and accurate surgical positioning of the head and acetabular cup in MoM THRs.
Tribology and wear of articular cartilage is associated with the mechanical properties, which are governed by the extracellular matrix (ECM). The ECM adapts to resist the loads and motions applied to the tissue. Most investigations take cartilage samples from quadrupeds, where the loading and motions are different to human. However, very few studies have investigated the differences between human and animal femoral head geometry and the mechanical properties of cartilage. This study assessed the differences between human, porcine, ovine and bovine cartilage from the femoral head; in terms of anatomical geometry, thickness, equilibrium elastic modulus and permeability. Diameter of porcine (3-6 months old), bovine (18-24 months old), ovine (4 years old) and human femoral heads were measured (n=6). Plugs taken out of the superior region of each femoral head and creep indentation was performed. The human femoral heads were obtained from surgery due to femoral neck fracture. Cartilage thickness was measured by monitoring the resistive force change as a needle traversed the cartilage and bone at a constant feed rate using a mechanical testing machine. The percentage deformation over time was determined by dividing deformation by thickness. A biphasic finite element model was used to obtain the intrinsic material properties of each plug. Data is presented as the mean ± 95% confidence limits. One-way ANOVA was used to test for significant differences (p < or = 0.05). Significant differences in average femoral head diameter were observed between all animals, where bovine showed the largest femoral head. Human cartilage was found to be significantly thicker than cartilage from all quadrupedal hips. Human cartilage had a significantly larger equilibrium elastic modulus compared to porcine and bovine cartilage. Porcine articular cartilage was measured to be the most permeable which was significantly larger than all the other species. No significant difference in permeability was observed between human and the other two animals: bovine and ovine (Table 1). The current study has shown that articular cartilage mechanical properties, thickness and geometry of the femoral heads differ significantly between different species. Therefore, it is necessary to consider these variations when choosing animal tissue to represent human.
Spinal total disc replacement (TDR) designs rely heavily on total hip replacement (THR) technology and it is therefore prudent to check that typical TDR devices have acceptable friction and torque behaviour. For spherical devices friction factor (f) is used in place of friction coefficient (mju). The range of loading for the lumbar spinal discs is estimated at perhaps 3 times body weight (BW) for normal activity rising to up to 6 times BW for strenuous activity[1]. For walking this equates to around 2000 N, which is the maximum load required by the ISO standard for TDR wear testing[2]. Three Prodisc-L TDR devices (Synthes Spine) were tested in a single station friction simulator. Bovine serum diluted to 25% was used as a lubricating medium. Flexion-extension was ±5 deg for all experiments with constant axial loading of 500, 2000 and 3000 N. The cycle run length was limited to 100 and the f and torque (T) values recorded around the maximum velocity of the cycle point and averaged over multiple cycles. Preliminary results shows that the 500 N loading produced the largest f of 0.05 ± 0.004. The 2000 N load, which approximates daily activity, gave f = 0.036 ± 0.05 and the 3000 N load gave f = 0.013 ± 0.003. The trend was for lower f with increasing loads. A lumbar TDR friction factor of 0.036 for a 2000N load and the reduction in f for increasing loads is comparable to the lower end of the range of values reported for THR in similar simulator studies using metal-on-polyethylene bearing materials[3]. The 3000 N result showing that increasing the load above that expected in daily activity does not raise the f could be important when considering rotational stability and anchorage in a TDR device because frictional torque at the bearing surfaces is proportional to the product of load, device radius and f.
High cup abduction angles generate increased contact stresses, higher wear rates and increased revision rates. However, there is no reported study about the influence of cup abduction on stresses under head lateralisation conditions for ceramic-on-Ceramic THA. A finite elements model of a ceramic-on-ceramic THA was developed in order to predict the contact area and the contact pressure, first under an ideal regime and then under lateralised conditions. A 32 mm head diameter with a 30 microns radial clearance was used. The cup was positioned with a 0°anteversion angle and the abduction angle was varied from 45° to 90°. The medial-lateral lateralisation was varied from 0 to 500 microns. A load of 2500 N was applied through the head center.Background
Material and method
Squeaking after total hip replacement has been reported in up to 10% of patients. Some authors proposed that sound emissions from squeaking hips result from resonance of one or other or both of the metal parts and not the bearing surfaces. There is no reported in vitro study about the squeaking frequencies under lubricated regime. The goal of the study was to reproduce the squeaking in vitro under lubricated conditions, and to compare the in vitro frequencies to in vivo frequencies determined in a group of squeaking patients. The frequencies may help determining the responsible part of the noise. Four patients, who underwent THR with a Ceramic-on-Ceramic THR (Trident(r), Stryker(r)) presented a squeaking noise. The noise was recorded and analysed with acoustic software (FMaster(r)). In-vitro 3 alumina ceramic (Biolox Forte Ceramtec(r)) 32 mm diameter (Ceramconcept(r)) components were tested using a PROSIM(r) hip friction simulator. The cup was positioned with a 75° abduction angle in order to achieve edge loading conditions. The backing and the cup liner were cut with a diamond saw, in order to avoid neck-head impingement and dislocation in case of high cup abduction angles (Figure1). The head was articulated ± 10° at 1 Hz with a load of 2.5kN for a duration of 300 cycles. The motion was along the edge. Tests were conducted under lubricated conditions with 25% bovine serum without and with the addition of a 3rd body alumina ceramic particle (200 μm thickness and 2 mm length). Before hand, engineering blue was used in order to analyze the contact area and to determine whether edge loading was achieved.INTRODUCTION
METHODS
Articular hyaline cartilage has a unique structural composition that allows it to endure high load, distribute load to bone and enables low friction movement in joints. A novel acellular xenogenic graft is proposed as a biological cartilage replacement, for repair of osteochondral defects. Acellular porcine cartilage has been produced using repeated freeze thaw cycles and washing using hypotonic buffers and sodium dodecyl sulphate solution (SDS; Keir, 2008). DNA content of the acellular matrix was reduced by 93.3% compared to native cartilage as measured by nanodrop spectrophotometry of extracted DNA, with a corresponding reduction in glycosaminoglycan (GAG) content. It was hypothesised that penetration of decellularisation solutions into the native tissue could be improved through deformation of the cartilage under confined compression and then allowing the osteochondral pin to recover in solution, allowing removal of cellular DNA and greater retention of the GAGs.Introduction
Hypothesis
It is believed that wear of replacement joints A five active degree of freedom (DOF) spine simulator was used to compare the effects of varying the kinematic and loading input parameters on a ProDisc-L TDR (Synthes Spine). A four DOF standard ISO (ISO18192-1) test was followed by a five DOF test which included the AP shear force. The standard ISO test was repeated on a second simulator (of identical design) but with the phasing of the lateral bend (LB) and flexion extension (FE) motions changed to be in-phase, creating a low cross-shear motion pattern. The standard ISO test was then modified to give half the ISO standard axial loading. All tests conducted were based on the ISO18192-1 standard for lumbar implants with 15 g/l protein lubricant and modified as described. Gravimetric wear measurements were taken every million cycles (mc) in units of milligrams (mg). Six discs were tested to give statistically significant results.Introduction
Methods
The biological response to UHMWPE particles generated by total joint replacements is one of the key causes of osteolysis, which leads to late failure of implants. Particles ranging from 0.1-1.0μm have been shown to be the most biologically active, in terms of osteolytic cytokine release from macrophages [1]. Current designs of lumbar total disc replacements (TDR) contain UHMWPE as a bearing surface and the first reports of osteolysis around TDR in vivo have appeared recently in the literature [2]. The current wear testing standard (ISO18192-1) for TDR specifies only four degrees of freedom (4DOF), i.e. axial load, flexion-extension, lateral bend and axial rotation. However, Callaghan et al. [3] described a fifth DOF, anterior-posterior (AP) shear. The aim of this study was to investigate the effect that this additional AP shear load component had on the size and morphology of the wear particles generated by ProDisc-L TDR devices over five million cycles in a spine simulator. A six-station lumbar spine simulator (Simulation Solutions, UK) was used to test ProDisc-L TDR components (Synthes Spine, USA) under the ISO 18192-1 standard inputs and with the addition of an AP load of +175 and −140N. Wear particles were isolated at 2 and 5 mc using a modified alkaline digestion protocol [4]. Particles were collected by filtration and imaged by high resolution FEGSEM. Particle number and volume distributions were calculated as described previously [4] and were compared statistically by one way ANOVA (p<0.05).Introduction
Methods
The search for the ideal bearing surface in Total Hip Replacements continues. The current ‘best’ materials are felt to be combinations of metal, ceramics and cross-linked polyethylene. Laboratory studies suggest that ceramic-on-metal articulations may provide distinct advantages. This study aims to identify the best bearing surface combination with the lowest adverse side effect profile. Between February 2004 and September 2007, 164 hips were replaced in 142 patients. 39% were male and 69% were female. The average age at surgery was 53 years (17-72 years). Follow-up assessment included radiographs, the Harris Hip Score and whole blood samples for metal ion levels. Complications to date included 3 hips which needed femoral revision because of surgery related factors, and 3 cases of sepsis of which 1 settled and 2 needed revision. One hip needed revision of head and liner to a larger bearing size for recurrent dislocations, and is no longer being followed up for blood metal ions. Post-operative whole blood metal ion levels were compared to pre-operative levels to determine the increase or decrease in metal ion levels. There were no changes in those patients with ceramic-on-ceramic and ceramic-on-polyethylene articulations. Moderately raised whole blood metal ion levels were noted at 3 months in the ceramic-on-metal group, while the metal-on-metal group show the greatest increase. This study agrees with laboratory bearing surface wear studies demonstrating lower wear rates in the ceramic-on-metal group compared to the metal-on-metal group. With concerns related to high blood metal ion levels in metal-on-metal articulations, ceramic-on-metal bearing surfaces may well become a bearing surface of choice in the future, but progress needs to be monitored in the longer term.
Dislocation remains one of the most common complications after total hip arthroplasty. Precise cup position appears to be a main factor as significant variations occur for frontal and sagittal acetabular tilt and anteversion according to sitting or standing positions. An innovative dual mobility ceramic-on-ceramic joint has been developed to solve these problems. The dual mobility ceramic-on-ceramic joint allows to move the rotation center much deeper inside the insert in order to increase the joint stability without negative impact on the ROM. This device revealed higher torques against subluxation in comparison to the classical Al-Al systems, even with 36mm head diameters, or 41 mm metal on metal bearings. The additional outer-bearing surface motion creates a second “adjustable acetabulum” due to the eccentration between the rotation center of the ball head and the rotation center of the bipolar head. This offset creates a resultant force that rotates the bipolar component. Using two bearing ceramic surfaces, the intermediate component acts as a “self adjusting cup”, dealing with the variations of pelvic orientation and acetabulum anteversion. The use of the dual mobility ceramic-on-ceramic joint seems an interesting alternative when facing difficult or unexpected situations for cup adjustment and cases with hip instability In a hip simulator in micro separation condition, the wear of the dual mobility ceramic-on-ceramic was less than 0.01 mm3/million cycles, the detection limit for wear measurement. There was no change in the surface roughness of the inserts. The design of the joint with the mobile ceramic head prevented edge loading of the head on the edge of the cup. No stripe wear was observed. Since 2006 more than 2000 dual mobility ceramic-on-ceramic systems have been implanted in Europe and clinical studies are conducted. The aim is to demonstrate the resistance to dislocation in primary total hip arthroplasty. Previous results over 125 patients in a prospective multicentric study show a Harris and Womac score equivalent to a standard hip prosthesis. No dislocations have been reported. No ceramic breakage or “squeaking” phenomenon appears. Dislocation and microseparation are major causes of failure for ceramic-ceramic hip prosthesis. When no ideal solution has been found for acetabular implantation, the dual mobility ceramic-on-ceramic device is a real alternative. The exclusive design of the bipolar head give the high resistance to wear and stripe wear to the dual mobility ceramic-on-ceramic joint. Reducing the risk of dislocation and reducing wear drastically are two advantages that can place the dual mobility ceramic-on-ceramic joint as the best choice in primary Total Hip Arthroplasty. Obviously this choice applies to recurrent dislocation also.
Discussion: The biological response to wear particles is strongly influenced by particle size and volume [
Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings. This has been attributed to reduced corrosive and adhesive wear, and differential hardness. The study assessed the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation. Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and CoCrMo alloy. Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. Testing was conducted in calf-serum for 2-million cycles. A standard simulator cycle was adapted, the head sub-luxed in the swing-phase forcing the head onto the cup rim at heel strike. The overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. The COM concept allows thin metal shells to be used with larger ceramic heads and protects against ceramic liner chipping. COM bearings are undergoing clinical trials, early data suggests reduced metal ion release in patients compared to metal-on-metal.
Ceramic-on-ceramic total hip replacements (THRs) have shown low wear volumes in standard gait hip simulator studies
1 Polystyrene FITC-conjugated FluoSpheres (FS; Invitrogen) in 20 nm, 40 nm, 0.2 μm and 1.0 μm sizes. 2a Complete Ceridust® 3615 (CD), a low MW polyethylene powder (size range 15 nm – 53 μm). 2b Nanometresized Ceridust® (fractionated by filtration using 10, 1, 0.1, 0.05 &
0.015 μm filters). 3 Clinically relevant GUR 1120 UHMWPE debris produced aseptically using a multidirectional wear rig. All particles were tested for the presence of endotoxin prior to culture with cells. Cells without particles were used as a negative control and 200 ng/ml LPS was used as a positive control. Cell viability was assessed using the ATP Lite assay (Perkin Elmer) and ELISA was used to determine TNF-alpha, IL-1beta, IL-6 and IL-8 release at 3, 6, 12 and 24 h.
Ceramic-on-metal (COM) bearings have shown reduced wear and friction compared with metal-on-metal (MOM) bearings in-vitro. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces, improved lubrication and differential hardness reducing adhesive wear. Clinical studies have also shown reduced metal ion levels in-vivo compared with MOM bearings. The aim of this study was to examine two explanted COM bearings (one head and cup, one head only), and to assess the effect of in-vivo changes on the wear performance of the COM bearings by comparing the wear of the explanted bearings with three new COM implants in a hip wear simulator. Two 28mm diameter COM bearings were provided for analysis. These were visually examined and surface profilometry was performed using a 2-D contacting profilometer (Form Talysurf, Taylor Hobson, UK). Scanning electron microscopy was used to image the regions of transfer on the ceramic heads, and EDX to assess the transfer composition (Philips XL30 ESEM). Hip simulator testing was conducted for 2 million cycles (Mc) comparing the explanted bearings with three new 28mm COM bearings. Tests were performed in a Prosim simulator (SimSol, UK), which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of − 15 to 30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted in the anatomical position. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide and was changed approximately every 0.33Mc. Wear was measured gravimetrically at 0.5, 1 and 2 Mc. Regions of material transfer, identified on both ceramic explant heads, were shown to be CoCr material by EDX analysis, suggesting metallic transfer from the metal cup. Profilometry traces across metallic transfer showed comparable surface roughness measurements compared to unworn material. The overall mean wear rate for the new COM bearings at 2Mc was 0.047 ± 0.06mm3/Mc. The mean wear rate for the explanted head articulated with a new cup was slightly lower at 0.034mm3/Mc. The mean wear rate for the explanted head and cup was highest at 0.15mm3/Mc. It was noted that the explanted head/cup had higher bedding in wear compared with the other bearings, but still significantly less than a new MOM bearing (mean bedding-in wear rate 2.03 ± 2.59 mm3/Mc). The steady-state wear was comparable with the new bearings. As the orientation of these implants in-vivo was unknown, it is proposed that the elevated wear during bedding-in of the explanted head/cup bearing may be due to the alignment of the components. The wear rates of the explanted ceramic head against a new cup were comparable with the new bearings, suggesting that the presence of metallic transfer on the ceramic head does not adversely affect the wear behaviour of COM bearings.
Squeaking noises of a similar frequency were recorded in-vitro and in-vivo. The lower frequency of squeaking recorded in-vivo, demonstrates a potential damping effect of the soft tissues. Therefore, the squeaking in the patients was probably related to the bearing surfaces and modified lubrication conditions that may be due to edge loading. The determined values of frequencies may help to analyze the squeaking patients in order to determine the mechanism generating the sound.
The combination of a ceramic head articulating against a metal acetabular liner (CoM) has shown reduced metal ion levels compared with a metal-on-metal bearing (MoM) in hip simulator studies. A randomized prospective clinical trial was undertaken using CoM and MoM bearings in an otherwise identical total hip procedure. The initial clinical results were encouraging. This report comprises a further review of metal ion data. Patients received identical components with the exception of the bearing surface material but all were 28mm diameter. All components were supplied by DePuy International Ltd. Patients were assessed pre-operatively, 3m, 12m and >
24m (median 32m). Whole blood samples were collected at regular follow-ups, frozen and analysed in batches using high resolution Inductively Coupled Plasma – Mass Spectrometry (ICP-MS). All recruited patients are included irrespective of outcome. However some patients failed to attend specific follow-ups and some contaminated samples had to be discarded. Statistical significance was analyzed using a non-parametric comparison (Mann-Whitney test). After 3m and 12m implantation there were between 21 and 24 patients available for analysis in both the CoM and MoM cohort and after >
24m point 10 and 9 respectively. There were four outliers (either Cr or Co >
10ug/l) in both the CoM and MoM groups. In common with previous studies (with the exception of two marginal outliers), these were related to component position. They were implanted with either a cup abduction angle of >
55°, an anteversion angle of >
30° or both. Other studies with the same design of component have reported no significant outliers. The median Cr and the Co levels are lower with the CoM bearing compared with the MoM at all measurements points following implantation. The median background (pre-operative) levels for the combined CoM and MoM group were Cr: 0.22ug/l and Co: 0.49ug/l. These were significantly different (p=0.006). In the CoM group, the median 12m Cr and Co values were 0.43ug/l and 0.72ug/l respectively. The comparable values for MoM are 0.68ug/l and 0.83ug/l. Increases in metal ion levels from pre-operative levels are used as the primary ion level outcome in this study because the background level will comprise of the order of 30–50% of the overall value. The increase in Cr for CoM and MoM from pre-op levels to 12m significantly different for Cr (p=0.015). It has a lower significance for combined metal ion levels (p=0.029). This difference in not significant for Co (p=0.195). In agreement with predictions from hip simulator studies, CoM bearings in this study produced lower levels of metal ions than comparable MoM bearings at all time points. However the difference is less than that predicted in the laboratory and is much more pronounced with Cr than with Co.
The aim of this study was to investigate the influence of cup inclination angle and head position on the wear of ceramic-on-ceramic total hip replacements.
Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings (Firkins et al., 1999). This has been attributed to a reduction in corrosive wear, differential hardness and a reduction in adhesive wear. In a clinical report on the use of a metal-on-ceramic hip replacement (Valenti et al., 2007) which consisted of a stainless steel head and alumina ceramic insert at revision 6-months post-op massive metallosis and macroscopic wear was observed. The aim of this study was to assess the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation. Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and high carbon (0.2wt%) CoCrMo alloy (DePuy International Ltd, UK). Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. The lubricant (25% calf-serum) was changed every 0.33Mc, wear was measured gravimetrically. Testing was conducted for 2-million cycles, a standard simulator cycle was adapted so the head subluxed in the swing phase forcing the head onto the cup rim at heel strike (Williams et al., 2006). The total overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup at heel strike caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. The explant described Valenti et al. included a stainless steel head, this is a softer material compared to CoCr, and wears at a higher level. It can be postulated that the wear under adverse conditions would be further increased. The COM concept can provide increased design flexibility; thin metal shells can be used with larger ceramic heads. Additionally the design protects against ceramic liner chipping. COM bearings are currently undergoing clinical trials, early data suggests reduced metal ion release in patients with COM bearings compared to metal-on-metal (Williams et al., 2007).
Total meniscectomy has been shown to induce osteoarthritic changes in the underlying articular cartilage(AC) and bone in the natural knee (Fairbank 1948; McDermott 2006). This indicates the meniscus plays an important protective role, providing joint congruity and distributing contact forces, hence reducing contact stress. However, no friction and wear studies have been performed on meniscectomy. The aim of this study was to study the tribological response of the medial compartmental natural knee with and without the intact meniscus, under physiological dynamic loading and motion. The effect of normal and reduced loading was investigated. Eighteen month old bovine medial compartmental knees were used. A pendulum friction simulator (Simulation Solutions, UK) was used to apply a dynamic axial loads with peak loads of 1000N (normal) and 260N (reduced). Flexion-extension of amplitude 23degrees was applied and the experiments ran for 3600 cycles at 1Hz. Lubricant was 25% bovine serum in saline. A 9.4 Tesla MRI (Bruker) scanner and Analyze software (Mayo Clinic, US) were used to calculate wear volumes. A surface profilometer (Talysurf, Taylor-Hobson, UK) was used to measure the surface roughness of the specimen before and after the test. Coefficient of friction was found to increase with increased loading, with and without meniscus. With meniscus intact, no wear was found on AC and contact stresses were 4.9MPa and 2.8MPa, for normal and reduced loading respectively. On removal of meniscus, friction was higher at both loading conditions and surface fibrillation found on some of the AC surfaces. Contact stresses rose to 17.2MPa and 8.6MPa for normal and reduced loading. This study has shown for the first time, the direct elevation of the coefficient of friction, immediate surface fibrillation and biomechanical wear of AC upon removal of the meniscus. On removal of meniscus, peak stresses rose and surface damage occurred on AC surfaces. The removal of the meniscus means forces act across smaller areas and contact stresses are increased. Wear is increased due to the subsequent increase in direct solid-solid contact and loss of fluid support due to the unique biphasic nature of AC. This further supports retaining meniscus whenever possible in knee joint surgery.
Metal-on-metal hip resurfacing has been introduced recently, due to its potential advantages of biomechanics and biotribology. However, a number of problems have been identified from clinical retrievals, including significant elevation of wear when the implant is mal-positioned. Our hypothesis is that implant mal-position and micro-lateralisation can result in edge contact, leading to increases in wear. The aim of this study was to investigate the combined effect of cup position and micro-lateralisation on the contact mechanics of metal-on-metal hip resurfacing prosthesis, in particularly to identify conditions which resulted in edge contact. Finite element (FE) method was used. A generic metal-on-metal hip resurfacing prosthesis was modelled. The bearing diameters of the femoral head and acetabular cup components were 54.49mm and 54.6mm respectively, with a diametral clearance between the head and the cup of 0.11mm. The resurfacing components were implanted into a hemi-pelvic hip joint bone model and all the materials in the FE model were assumed to be homogenous, isotropic and linear elastic (Udofia et al 2007). The FE models consisted of approximately 80,000 elements, which were meshed in I-DEAS (Version 11, EDS, USA) and solved using ABAQUS (Version 6.7-1, Dassault Systèmes). For this study, the femoral component was fixed with an inclination angle of 45° and an anteversion angle of 10°. The orientation of the acetabular cup was varied, using inclination angles of 35° and 65°, and anteversion angles between −10° to 30°. Contact at the bearing surface between the cup and femoral head was modelled using frictionless surface-based elements, simulating a fully lubricated situation, as coefficients of friction less than 0.1 would not have appreciable effects on the predicted contact mechanics. The femoral component was fixed into the femur (except the guide pin) using PMMA cement with an average thickness of approximately 1mm. The other contact interfaces in the FE model (cup/acetabulum, cement/bone and cement/femoral component) were all assumed to be rigidly bonded. The hip joint model was loaded through a fixed resultant hip joint contact force of 3200N, and was applied through medial, anterior muscle forces and subtrochanteric forces to simulate the mid-to-terminal stance phase (approximately 30% – 50%) of the gait cycle (Bergmann et al., 1993). Micro-lateralisation was modelled through displacing the femoral head laterally, up to 0.5mm, relative the centre of the cup. Edge contact was detected once the inclination angle became greater than 65°. The effect of ante-version was to further shift the contact area towards the edge of the cup, nevertheless no edge contact was found for ante-version angles up to 25° and inclination angles below 55°. However, when the micro-lateralisation was introduced, edge contact was detected at a much smaller inclination angle. For example, even with a micro-lateralisation of 0.5 mm, edge contact occurred at an inclination angle of 45°. This study highlights the importance of surgical techniques on the contact mechanics and tribology of metal-on-metal hip resurfacing and potential outcome of these devices.
Young and active patients require bearing materials that can last up to 200 million walking steps, ten fold greater than conventional polyethylene bearings. Cross linked polyethylene provides reduced wear rate compared to conventional polyethylene, and further advantage is gained from using ceramic femoral heads. However in polyethylene bearings wear increases with the head diameter, and there is currently little opportunity to use head sizes greater then 36mm diameter. There is evidence of polyethylene fracture with steeply positioned cups. Ceramic on ceramic bearings provide substantially lower wear rates than polyethylene bearings. Steep cups, lateralised heads or neck impingement can lead to head contact on superior rim of the cup and stripe wear, but this still results in very low wear rates. Recently developed ceramic matrix composites Biolox Delta provide greater resistance to stripe wear. In a few patients stripe wear may lead to squeaking. Metal on metal bearings also provide substantially lower wear than polyethylene bearings. However there remains concern about elevated metal ion levels in a few patients and resultant risk of hypersensitivity reactions. In metal on metal bearings larger head sizes and reduced diametrical clearance can lead to reduced wear. Increased wear is associated with steep cups and lateralised heads resulting in rim wear. Ceramic on metal bearings have been introduced recently as the first differential hard on hard bearings. These bearings show substantial reduction in wear, corrosive wear mechanisms, metal ion levels in laboratory simulators and initial clinical studies have shown a reduction in metal ion levels in vivo compared to metal on metal bearings.
Total disc replacement is an alternative to spinal fusion in treating degenerative disc disease, whilst preserving motion and reducing the risk of subsequent DDD at adjacent levels. Current designs have evolved from technology used in total hip replacements with metal-metal or metal-PE bearing surfaces. These articulating systems may be prone to wear and it is essential the medical engineering community assess their performance using appropriate simulators Utilising previous Leeds simulation design experience, current knowledge on spinal kinetics and prevailing Standards for spinal testing, a comprehensive set of requirements was generated from which a simulator design was produced. The Leeds Spine wear simulator, developed in conjunction with Simulation Solutions Ltd, incorporates five active degrees of freedom: axial compression, axial rotation, flexion-extension, lateral bending and anterior-posterior displacement. The fifth DOF, unique to the Leeds simulator, is anticipated to be particularly important for the study of mobile bearing devices such as the Charité. Loads and motions are applied by electro-mechanical actuators, providing accurate and precise control without the low band width suffered from pneumatics or contamination from hydraulic systems. This validation study determines the accuracy and precision of the simulator with regards to the degrees of freedom required by the newly published standard ISO 18192-1. Here, loads and motions have to be within ±5% of the maximum value and ±0.5degrees, respectively. The simulator’s response to demand input signals was determined for load and motion using independent measuring devices; a digital inclinometer for motions and load cell for force. The load calibration was found to be within ±1% of the maximum load within the specified load range of 600–2000N. Flexion-extension, lateral bending and axial rotation were found to be within ±0.5, ±0.3 and ±0.5 degrees respectively, within and beyond the operating ranges specified by ISO. The Leeds spine wear simulator is the first orthopaedic wear simulator to include electro-mechanical actuators for all active DOF, and the first spinal wear simulator to include a minimum of 5 active DOF. This novel simulator meets the demanding tolerances required by ISO for testing of total disc replacements. Validation of the simulator is currently being undertaken to determine its suitability against explanted devices and debris located within tissues.
Ceramic head and metal liner hip replacements (COM) have shown reduced wear in comparison to metal-on-metal (MOM) bearings. The aim of this study was to further assess the performance by a wear simulator study under standard and adverse conditions, including the wear of a metal head against a ceramic liner. Components were Biolox Delta and CoCrMo alloy. Hip simulator testing applied a simplified walking cycle to anatomically mounted prostheses. The lubricant was 25% calf-serum and wear was measured gravimetrically. In hip simulator testing with edge loading a standard cycle was adapted so the head sub-luxed in the swing phase forcing the head onto the edge of the cup at heel strike, this was applied to ceramic on metal and metal on ceramic material combinations. Under standard conditions the total overall mean wear rate of the MOM THR (1.01±0.38mm3/Mc) was significantly higher in comparison to the COM and COC (<
0.015mm3/Mc). The overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. Reduced wear from COM bearings will address some concerns associated with MOM THRs regarding reports of elevated ion levels clinically. These studies have provided valuable data demonstrating reduced wear with COM bearings. COM bearings are undergoing clinical trials, early data suggests reduced metal ion release in patients compared to metal-on-metal
A randomised prospective study of four bearing surfaces in hip replacements is being conducted. The primary objective is to identify the best long term bearing surf ace clinically and radiographically, and metal ion levels have been measured in all cases. Patients have been randomised to the four bearing surfaces viz. Ceramic-on-XLinked Polyethelene, Ceramic-on-Ceramic, Metal-on-Metal and Ceramic-on-Metal. Pre-operative blood samples and follow-up blood samples for metal ion analysis using ICP-MS method have been taken in all patients. As at February 2008 187 patients have been recruited, and metal ion levels at one year are available in 52 patients. Metal ion levels are not increased with Ceramic-on-XLPE or Ceramic-on-Ceramic bearings. At one year follow-up the metal ion levels in Ceramic-on–Metal bearings is half that of Metal-on-Metal bearings using mean levels, and one third using median levels. Of note is that chromium levels in Ceramic-on-Metal bearings is the least elevated. Due to the laboratory evidence that ceramic-on-metal bearings have the best surf ace wear characteristics with no head stripe wear on a ceramic head, and the laboratory and clinic al evidence of lower metal ion levels, Ceramic-on-Metal hip replacements could be one of the bearing surfaces of the future.
A randomised prospective study of 4 bearing surfaces in hip replacements is being conducted. The primary objective is to identify the best long term bearing surface clinically and radiographically, and metal ion levels have been measured in all cases. Patieents have been randomised to the 4 bearing surfaces viz. Ceramic on XLinked Poly, Ceramic on Ceramic, Metal on Metal and Ceramic on Metal. Pre operative blood samples and follow up blood samples for metal ion analysis using the ICPMS method have been taken in all patients. As at February 2008 187 patients have been recruited, and metal ion levels at 1 year are available in 52 patients. Metal ion levels are not increased with Ceramic on XLinked Poly or Ceramic on Ceramic bearings. At 1 year follow up the metal ion levels in Ceramic on Metal bearings is half that of Metal on Metal bearings using the mean levels, and one third using the madian levels. Of note is that the chromium levels in Ceramic on Metal bearings is the least elevated. Due to laboratory evidence that Ceramic on Metal bearings have the best surface wear characteristics with no head stripe wear, and laboratory and clinical evidence of lower metal ion blood levels, Ceramic on Metal hip replacements could be a bearing surface of the future.
The use of hard-on-hard hip prostheses has highlighted specific problems like the “stripe-wear” and the squeaking. Many authors have related these phenomena to a micro-separation between the cup and the head. The goal of the study was to model the hip kinematics under micro-separation regime in order to develop a computational simulator for total hip prosthesis including a joint laxity, and to use it to perform a sound analysis. A three-dimensional model of the Leeds II hip simulator was developed on ADAMS® software. A spring was used to introduce a controlled micro-separation (less than 500 microns) during the swing phase of the walking cycle. The increase of the load during the stance phase induced a relocation of the head in the cup. Values of the medial-lateral separation predicted from the model were compared to experimental data measured using a LVDT of less than 5 microns precision. Theoretical wear path predicted from the model was compared to the literature data. The frequencies of the vibratory phenomena were determined, using the Fourier transformation. There was an excellent correlation between the theoretical prediction and the experimental measurement of the medial-lateral separation during the walking cycle (0.92). Edge-loading contact occurred during 57% of the cycle according to the model and 47% according to the experimental data. Velocity and acceleration were increased during the relocation phase in a chaotic manner, leading to vibration. The contact force according to the model had also a chaotic variation during the micro-separation phase, suggesting a chattering movement. Fourier transformation showed many frequencies in the audible area. A three-dimensional computational model of the kinematics of the hip after total replacement was developed and validated with an excellent precision under micro separation. It highlighted possible explanations for the squeaking that may occur during either relocation phase or edge loading.
Ceramic on metal bearings for hip replacement have shown reduced friction, wear, and metal ion levels in comparison to metal on metal bearings. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces and improved lubrication and differential hardness and reduction in adhesive wear. The aim of this study was to further assess the performance of novel differential hardness COM THRs in two different bearing configurations. The effect of bearing configuration was examined by comparing COM (ceramic head on metal liner) with metal-on-ceramic (metal head on ceramic liner) (MOC) bearings in micro-separation hip simulator testing. Components used were zirconia-platelet toughened alumina (Biolox Delta) heads and high carbon (0.2wt%) CoCrMo alloy cups, tested in COM and MOC configurations, (, (DePuy International Ltd, UK). Micro-separation hip simulator testing was conducted for 2 million cycles (Mc) using a Prosim hip simulator (SimSol, UK), which applied a twin peak loading cycle and walking motions with the prosthesis positioned in the anatomical position. The lubricant (25% calf serum) was changed approximately every 0.33Mc and wear was measured gravimetrically. A negative force was applied to the head during the swing phase, to produce a joint laxity and head – rim contact, the head relocated in the stance phase. The total overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/ Mc). The contact of the head against the rim of the cup at heel strike caused deep stripe wear on the metallic heads of the MOC bearings. Stripes of metallic transfer were visible on all the ceramic heads (COM bearings). The COM bearings had much lower wear rates than the MOC bearings under harsh micro-separation conditions. This suggests that the head in a differential hardness bearing should be the harder material. The COM concept also provides increased design flexibility; thin metal shells can be used with larger ceramic heads. Additionally the design protects against ceramic liner chipping. COM bearings are currently undergoing clinical trials.
Large diameter metal-on-metal (MOM) bearings are becoming increasingly popular for young, active patients. Clearance is a particularly important consideration for designing MOM implants, considering historical experience of equatorial contact and high frictional torque. Lubrication theory predicts increasing the clearance will result in diminished lubrication, resulting in increased friction and wear. Clinical cases of transient squeaking in patients with resurfacing bearings have been noted in recent years, with some reporting an incidence of up to 10% between 6 months and 2 years post-implantation. This study aimed to investigate the impact of increasing clearance on the lubrication, friction and squeaking of a large diameter metal-on-metal resurfacing bearing through frictional studies. Clinical-grade MOM implants of 55mm diameter and 100μm diametric clearance, and custom-made, 55mm bearings with diametric clearances of approximately 50μm and 200μm (DePuy International Ltd) were tested in a friction simulator. Components were inverted with a flexion-extension of ±25o applied to the head and lubricated with 25% and 100% newborn bovine serum. A peak load of 2kN, with swing-phase loads of 25N, 100N and 300N were applied. Sound data was recorded during each friction test using a MP3 recorder and pre-amplifier. A microphone was set up at a distance of 50mm from the implant, and data recorded over a minimum of 10 seconds where sound was generated. Sound data was assessed through narrow band analysis on Frequency Master software (Cirrus Research, UK). Lubrication was assessed by directly measuring the separation between the head and cup during the test cycle by ultrasonic methods (Tribosonics, UK). An ultrasound sensor was bonded to the back of the cup and reflection measurements were taken during the friction tests with a sampling rate of 100Hz. Using equations which related reflection coefficient to lubricant properties and thickness, values for the film thickness were calculated. The surface replacement with the largest clearance yielded the highest friction factor for each test condition. The difference between the large clearance bearing and the smaller clearance samples was statistically significant in 25% bovine serum, the more clinically relevant lubricant (ANOVA, p<
0.05). The 50μm clearance group yielded similar results to the 100μm clearance bearing, although a slight increase in friction was observed. Squeaking occurred during every test in the large clearance group. There was a reduced incidence of squeaking in the smaller clearances, with the lowest incidence observed in the 100μm clearance group. The smallest separation of the head and cup was observed within the large clearance bearings. The best lubrication condition measured ultrasonically was observed within the 100μm clearance bearing. There appeared to be good correlation between friction, lubrication and the incidence of squeaking. This study suggests a large diametric clearance results in reduced lubrication, increased friction and an increased incidence of squeaking. However, there is a minimum diametric clearance that can be tolerated, as clearance must accommodate the manufacturing tolerance.
Clinical reports of surgical intervention options, such as spacers or hemi-arthroplasties, particularly for treatment of young arthritic patients, have been poor [ Experiments were conducted in an anatomic pendulum friction simulator (SimSol, UK) using the medial femoral condyle of a bovine knee joint articulating against two conforming stainless steel (316L) tibial plates (R=50mm and 100mm). A simplified physiologic knee loading profile was applied represent both low loading and much higher physiological loading conditions, with peak load between 259N – 1.5kN). Tests were conducted in 25% bovine serum and run for 3600 and 300 cycles under the low and high loading conditions respectively. The motion was cycled at 1Hz with amplitude between −10°–13.1°. Cartilage wear was assessed qualitatively from surface roughness measurements using a surface profile using a surface profilometer (Taylor Hobson, UK). The friction and wear of cartilage articulating against the conforming tibial plates were compared to a positive control flat tibial plate model [
The steady state wear rate for the ceramic/cross-linked polyethylene bearing combinations was 4.7 mm3/million cycles. This was a significant 40% reduction compared to the wear rate of the cobalt chrome/cross-linked polyethylene bearing combinations at 8.1 mm3/million cycles (p<
0.01).
Considerable differences in kinematics between different designs of knee prostheses and compared to the natural knee have been seen in vivo. Most noticeably, lift off of the femoral condyles from the tibial insert has been observed in many patients. The aim of this study was to simulate lateral femoral condylar lift off in vitro and to compare the wear of fixed bearing knee prostheses with and without lift off. Twelve PFC Sigma cruciate retaining fixed bearing knees (DePuy, Leeds, UK) were tested using six station simulators (Prosim, Manchester, UK). The kinematic input conditions were femoral axis loading (maximum 2.6 kN), flexion-extension (0–58°), internal/external rotation (±5°) and anterior/posterior displacement (0–5 mm). Six knees were tested under these standard conditions for 4 million cycles. Six knees were tested under these conditions with the addition of lateral femoral condylar lift off, for 5 million cycles. The lubricant used was 25% newborn calf serum. Wear of the inserts was determined gravimetrically. Under the standard kinematic conditions the mean wear rate with 95% confidence limits was 8.8 ± 4.8 mm 3/million cycles. When femoral condylar lift off was simulated the mean wear rate increased to 16.4 ± 2.9mm 3/million cycles, which was statistically significantly higher (p <
0.01, Students t-test). The wear patterns on the femoral articulating surface of all the inserts showed more burnishing wear on the medial condyle than the lateral. However, in the simulation of lift off the medial condyle was more aggressively worn with evidence of adhesion and surface defects. The presence of lateral femoral condylar lift off accelerated the wear of PFC Sigma cruciate retaining fixed bearing knees. The lateral lift off produced uneven loading of the bearing, resulting in elevated contact stresses and hence more wear damage to the medial side of the insert. The implications of condylar lift off include increased wear of the polyethylene and possible osteolysis.
Different wear rates have been reported for ceramic-on-ceramic (COC) and metal-on-metal (MOM) hip replacements tested in simulators with different loading conditions and lubricants. We postulate that differences in wear rates may be associated with changes in lubrication and friction in the joint. This study aimed to compare the friction of COC and MOM bearings under different lubrication regimes, simulated by varying swing-phase loads and lubricants. Alumina COC and CoCr MOM 28mm-diameter bearings were studied in a pendulum friction simulator. Flexion-extension of +/−25 degrees was applied to the head, a peak load of 2kN and swing-phase loads of 25N,100N, 300N used. Lubricants used included water, 25% and 100%-bovine serum. COC and MOM bearings showed increased friction as the swing-phase load increased. COC bearings produced higher friction in 100%-serum compared to 25%-serum. In contrast, friction was lower when MOM bearings were tested in 100%-serum compared to 25%-serum. When COC bearings were tested in water, the friction decreased in comparison to testing in serum, however, MOM friction was higher in water. Increasing the swing-phase load reduced the thickness of the fluid-film in the stance-phase and this increased friction. The increase in friction when COC bearings were tested in 100%-serum (compared to 25%) may be due to the increased forces required to shear the increased concentration of proteins, similarly friction is reduced in water. MOM bearing friction was reduced in 100%-serum, in this instance increased proteins may be acting as solid-phase lubricants, and similarly MOM friction increased in water.
The product recall of Desmarquest Zirconia heads in 2001 was associated with specified batches of material. Despite of this fact, concerns raised over the stability of Zirconia led to a vast decrease in the use of Zirconia for hip prostheses. While there is evidence in the literature suggesting that Zirconia may become unstable, there remain many prostheses with Zirconia heads in use today. The purpose of this study was to report the condition observed in retrieved Zirconia heads not included in the product recall. The bearing surfaces of seven retrieved 22mm diameter Zirconia on UHMWPE hip prostheses were investigated to determine whether any degradation of the Zirconia occurred in-vivo. All seven of the Zirconia heads were manufactured by Saint-Gobain Cerammiques Avancees Desmarquest and implantation time varied from 1 to 10 years. Components were analysed by Talysurf, Interferometer, SEM and XRD and compared to new components. Talysurf of the components revealed an average surface roughness ranging from 0.004 to 0.007 micrometers Ra. This was only slightly rougher than new ceramic components which generally have an Ra of 0.003 micrometers. SEM of the surfaces did not reveal any difference between the retrieved components and new components. Further surface XRD of 4 of the 7 heads, as shown in Figure 1, showed very small percentages of monoclinic phase (28 degrees 2 theta) with predominantly tetragonal phase (30 degrees 2theta), similar to what is observed in new components. Figure 1: XRD of typical retrieved ZR head surface. All seven retrieved heads demonstrated no evidence suggesting that degradation of the Zirconia had occurred in-vivo.
In contrast, the release of the inflammatory cytokine TNF-α and the multifunctional growth factor TGF-β-2 occurred at lower doses (0.0005 to 5 μm3/cell for TNF-α and 0.5 to 50 μm3/cell for TGF-β-2). No release of IL-6 was detected at any dose. Only growth factor FGF-23 was increased in similar pattern to the DNA damage.
