Material loss at the femoral head taper: a comparison study of the Exeter metal-on-polyethylene and contemporary metal-on-metal total hip arthroplasty.

AIMS: There are limited published data detailing the volumetric material loss from tapers of conventional metal-on-polyethylene (MoP) total hip arthroplasties (THAs). Our aim was to address this by comparing the taper wear rates measured in an explanted cohort of the widely used Exeter THA with those measured in a group of metal-on-metal (MoM) THAs. PATIENTS AND METHODS: We examined an existing retrieval database to identify all Exeter V40 and Universal MoP THAs. Volumetric wear analysis of the taper surfaces was conducted using previously validated methodology. These values were compared with those obtained from a series of MoM THAs using non-parametric statistical methodology. A number of patient and device variables were accounted for using multiple regression modelling. RESULTS: A total of 95 Exeter MoP and 249 MoM THAs were examined. The median volumetric loss from the MoM cohort was over four times larger than that from the MoP cohort (1.01 mm3 vs 0.23 mm3, p < 0.001), despite a significantly shorter median period in vivo for the MoM group (48 months vs 90 months, p < 0.001). Multiple regression modelling indicated that the dominant variables leading to greater female taper material loss were bearing diameter (p < 0.001), larger female taper angles (p < 0.001), and male titanium stem tapers (p < 0.001). CONCLUSION: Consistent with the long-term clinical success of the device, the volumetric material loss from Exeter femoral head tapers was, in general, small compared with that from larger-diameter MoM head tapers. Cite this article: Bone Joint J 2018;100-B:1310-9.

Aseptic lymphocyte-dominated vasculitis-associated lesions are related to changes in metal ion handling in the joint capsules of metal-on-metal hip arthroplasties.

OBJECTIVES: We have encountered patients who developed large joint fluid collections with massive elevations in chromium (Cr) and cobalt (Co) concentrations following metal-on-metal (MoM) hip arthroplasties. In some cases, retrieval analysis determined that these ion concentrations could not be explained simply by the wear rates of the components. We hypothesized that these effects may be associated with aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL). PATIENTS AND METHODS: We examined the influence of the ALVAL grade on synovial fluid Co and Cr concentrations following adjustment for patient and device variables, including volumetric wear rates. Initially restricting the analysis to include only patients with one MoM hip resurfacing device, we performed multiple regression analyses of prospectively collected data. We then repeated the same statistical approach using results from a larger cohort with different MoM designs, including total hip arthroplasties. RESULTS: In the resurfacing cohort (n = 76), the statistical modelling indicated that the presence of severe ALVAL and a large fluid collection were associated with greater joint fluid Co concentrations after adjustment for volumetric wear rates (p = 0.005). These findings were replicated in the mixed implant group (n = 178), where the presence of severe ALVAL and a large fluid collection were significantly associated with greater fluid Co concentrations (p < 0.001). CONCLUSION: The development of severe ALVAL is associated with elevations in metal ion concentrations far beyond those expected from the volumetric loss from the prosthetic surfaces. This finding may aid the understanding of the sequence of events leading to soft-tissue reactions following MoM hip arthroplasties.Cite this article: D. J. Langton, R. P. Sidaginamale, T. J. Joyce, J. G. Bowsher, J. P. Holland, D. Deehan, A. V. F. Nargol, S. Natu. Aseptic lymphocyte-dominated vasculitis-associated lesions are related to changes in metal ion handling in the joint capsules of metal-on-metal hip arthroplasties. Bone Joint Res 2018;7:388-396. DOI: 10.1302/2046-3758.76.BJR-2018-0037.

A comparison study of stem taper material loss at similar and mixed metal head-neck taper junctions.

AIMS: We sought to determine whether cobalt-chromium alloy (CoCr) femoral stem tapers (trunnions) wear more than titanium (Ti) alloy stem tapers (trunnions) when used in a large diameter (LD) metal-on-metal (MoM) hip arthroplasty system. PATIENTS AND METHODS: We performed explant analysis using validated methodology to determine the volumetric material loss at the taper surfaces of explanted LD CoCr MoM hip arthroplasties used with either a Ti alloy (n = 28) or CoCr femoral stem (n = 21). Only 12/14 taper constructs with a rough male taper surface and a nominal included angle close to 5.666° were included. Multiple regression modelling was undertaken using taper angle, taper roughness, bearing diameter (horizontal lever arm) as independent variables. Material loss was mapped using a coordinate measuring machine, profilometry and scanning electron microscopy. RESULTS: After adjustment for other factors, CoCr stem tapers were found to have significantly greater volumetric material loss than the equivalent Ti stem tapers. CONCLUSION: When taper junction damage is identified during revision of a LD MoM hip, it should be suspected that a male taper composed of a standard CoCr alloy has sustained significant changes to the taper cone geometry which are likely to be more extensive than those affecting a Ti alloy stem. Cite this article: Bone Joint J 2017;99-B:1304-12.

Explant analysis of the Biomet Magnum/ReCap metal-on-metal hip joint.

OBJECTIVES: The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces. METHODS: In this study, a coordinate measuring machine (CMM) was used to measure the wear on five failed cementless Biomet Magnum/ReCap/ Taperloc large head MoM THAs, along with one Biomet ReCap resurfacing joint. Surface roughness measurements were also taken. The reason for revision of these implants was pain and/or adverse reaction to metal debris (ARMD) and/or elevated blood metal ion levels. RESULTS: The mean wear rate of the articulating surfaces of the heads and acetabular components of all six joints tested was found to be 6.1 mm3/year (4.1 to 7.6). The mean wear rate of the femoral head tapers of the five THAs was 0.054 mm3/year (0.021 to 0.128) with a mean maximum wear depth of 5.7 µm (4.3 to 8.5). CONCLUSION: Although the taper wear was relatively low, the wear from the articulating surfaces was sufficient to provide concern and was potentially large enough to have been the cause of failure of these joints. The authors believe that patients implanted with the ReCap system, whether the resurfacing prosthesis or the THA, should be closely monitored.Cite this article: S. C. Scholes, B. J. Hunt, V. M. Richardson, D. J. Langton, E. Smith, T. J. Joyce. Explant analysis of the Biomet Magnum/ReCap metal-on-metal hip joint. Bone Joint Res 2017;6:113-122. DOI: 10.1302/2046-3758.62.BJR-2016-0130.R2.

The clinical implications of metal debris release from the taper junctions and bearing surfaces of metal-on-metal hip arthroplasty: joint fluid and blood metal ion concentrations.

AIMS: We wished to investigate the influence of metal debris exposure on the subsequent immune response and resulting soft-tissue injury following metal-on-metal (MoM) hip arthroplasty. Some reports have suggested that debris generated from the head-neck taper junction is more destructive than equivalent doses from metal bearing surfaces. PATIENTS AND METHODS: We investigated the influence of the source and volume of metal debris on chromium (Cr) and cobalt (Co) concentrations in corresponding blood and hip synovial fluid samples and the observed agglomerated particle sizes in excised tissues using multiple regression analysis of prospectively collected data. A total of 199 explanted MoM hips (177 patients; 132 hips female) were analysed to determine rates of volumetric wear at the bearing surfaces and taper junctions. RESULTS: The statistical modelling suggested that a greater source contribution of metal debris from the taper junction was associated with smaller aggregated particle sizes in the local tissues and a relative reduction of Cr ion concentrations in the corresponding synovial fluid and blood samples. Metal debris generated from taper junctions appears to be of a different morphology, composition and therefore, potentially, immunogenicity to that generated from bearing surfaces. CONCLUSION: The differences in debris arising from the taper and the articulating surfaces may provide some understanding of the increased incidence of soft-tissue reactions reported in patients implanted with MoM total hip arthroplasties compared with patients with hip resurfacings. Cite this article: Bone Joint J 2016;98-B:925-33.

Resolving the viscoelasticity and anisotropy dependence of the mechanical properties of skin from a porcine model.

The mechanical response of skin to external loads is influenced by anisotropy and viscoelasticity of the tissue, but the underlying mechanisms remain unclear. Here, we report a study of the main effects of tissue orientation (TO, which is linked to anisotropy) and strain rate (SR, a measure of viscoelasticity), as well as the interaction effects between the two factors, on the tensile properties of skin from a porcine model. Tensile testing to rupture of porcine skin tissue was conducted to evaluate the sensitivity of the tissue modulus of elasticity (E) and fracture-related properties, namely maximum stress (σU) and strain (εU) at σU, to varying SR and TO. Specimens were excised from the abdominal skin in two orientations, namely parallel (P) and right angle (R) to the torso midline. Each TO was investigated at three SR levels, namely 0.007-0.015 s(-1) (low), 0.040 s(-1) (mid) and 0.065 s(-1) (high). Two-factor analysis of variance revealed that the respective parameters responded differently to varying SR and TO. Significant changes in the σU were observed with different TOs but not with SR. The εU decreased significantly with increasing SR, but no significant variation was observed for different TOs. Significant changes in E were observed with different TOs; E increased significantly with increasing SR. More importantly, the respective mechanical parameters were not significantly influenced by interactions between SR and TO. These findings suggest that the trends associated with the changes in the skin mechanical properties may be attributed partly to differences in the anisotropy and viscoelasticity but not through any interaction between viscoelasticity and anisotropy.

In vitro wear testing of a contemporary design of reverse shoulder prosthesis.

Reverse shoulder arthroplasty is an increasingly common surgical intervention. However there are concerns and known limitations in relation to such joint replacement, while novel designs of reverse shoulder prostheses continue to appear on the market. Many claim to offer improvements over older designs but such assertions are difficult to validate when there is no consensus as to how such implants should be tested in vitro or even if such testing is necessary. In order to permit appropriate in vitro testing of reverse shoulder prostheses a unique, multi-station test rig was designed which was capable of applying motion in three axes to test prostheses. The shoulder simulator can apply up to 110° of motion in the flexion-extension and abduction-adduction axes and up to 90° in the internal-external rotation axis. Dynamic loading of up to 1500 N can be provided. The simulator is computer controlled so that the motions and loading associated with particular activities of daily living can be applied. A 4.5 million cycle wear test of commercially available reverse shoulder prostheses was undertaken using a 'mug to mouth' activity of daily living. Gravimetric analysis was used to characterise wear. After 4.5 million cycles of 'mug to mouth', the average wear rate of the test components was 14.3mm(3)/million cycles. Polyethylene test components showed a reduction in roughness and the median wear particle diameter was 167 nm. A three axis shoulder simulator has been designed and used to successfully test multiple samples of a commercially available reverse shoulder prosthesis.

The influence of the strength of bone on the deformation of acetabular shells: a laboratory experiment in cadavers.

Concerns have been raised that deformation of acetabular shells may disrupt the assembly process of modular prostheses. In this study we aimed to examine the effect that the strength of bone has on the amount of deformation of the acetabular shell. The hypothesis was that stronger bone would result in greater deformation. A total of 17 acetabular shells were inserted into the acetabula of eight cadavers, and deformation was measured using an optical measuring system. Cores of bone from the femoral head were taken from each cadaver and compressed using a materials testing machine. The highest peak modulus and yield stress for each cadaver were used to represent the strength of the bone and compared with the values for the deformation and the surgeon's subjective assessment of the hardness of the bone. The mean deformation of the shell was 129 µm (3 to 340). No correlation was found between deformation and either the maximum peak modulus (r² = 0.011, t = 0.426, p = 0.676) or the yield stress (r² = 0.024, t = 0.614, p = 0.549) of the bone. Although no correlation was found between the strength of the bone and deformation, the values for the deformation observed could be sufficient to disrupt the assembly process of modular acetabular components.

Practical considerations for volumetric wear analysis of explanted hip arthroplasties.

OBJECTIVES: Wear debris released from bearing surfaces has been shown to provoke negative immune responses in the recipient. Excessive wear has been linked to early failure of prostheses. Analysis using coordinate measuring machines (CMMs) can provide estimates of total volumetric material loss of explanted prostheses and can help to understand device failure. The accuracy of volumetric testing has been debated, with some investigators stating that only protocols involving hundreds of thousands of measurement points are sufficient. We looked to examine this assumption and to apply the findings to the clinical arena. METHODS: We examined the effects on the calculated material loss from a ceramic femoral head when different CMM scanning parameters were used. Calculated wear volumes were compared with gold standard gravimetric tests in a blinded study. RESULTS: Various scanning parameters including point pitch, maximum point to point distance, the number of scanning contours or the total number of points had no clinically relevant effect on volumetric wear calculations. Gravimetric testing showed that material loss can be calculated to provide clinically relevant degrees of accuracy. CONCLUSIONS: Prosthetic surfaces can be analysed accurately and rapidly with currently available technologies. Given these results, we believe that routine analysis of explanted hip components would be a feasible and logical extension to National Joint Registries. Cite this article: Bone Joint Res 2014;3:60-8.

Blood metal ion testing is an effectivescreening tool to identify poorly performing metal-on-metal bearingsurfaces.

OBJECTIVES: The aims of this piece of work were to: 1) record the background concentrations of blood chromium (Cr) and cobalt (Co) concentrations in a large group of subjects; 2) to compare blood/serum Cr and Co concentrations with retrieved metal-on-metal (MoM) hip resurfacings; 3) to examine the distribution of Co and Cr in the serum and whole blood of patients with MoM hip arthroplasties; and 4) to further understand the partitioning of metal ions between the serum and whole blood fractions. METHODS: A total of 3042 blood samples donated to the local transfusion centre were analysed to record Co and Cr concentrations. Also, 91 hip resurfacing devices from patients who had given pre-revision blood/serum samples for metal ion analysis underwent volumetric wear assessment using a coordinate measuring machine. Linear regression analysis was carried out and receiver operating characteristic curves were constructed to assess the reliability of metal ions to identify abnormally wearing implants. The relationship between serum and whole blood concentrations of Cr and Co in 1048 patients was analysed using Bland-Altman charts. This relationship was further investigated in an in vitro study during which human blood was spiked with trivalent and hexavalent Cr, the serum then separated and the fractions analysed. RESULTS: Only one patient in the transfusion group was found to have a blood Co > 2 µg/l. Blood/Serum Cr and Co concentrations were reliable indicators of abnormal wear. Blood Co appeared to be the most useful clinical test, with a concentration of 4.5 µg/l showing sensitivity and specificity for the detection of abnormal wear of 94% and 95%, respectively. Generated metal ions tended to fill the serum compartment preferentially in vivo and this was replicated in the in vitro study when blood was spiked with trivalent Cr and bivalent Co. CONCLUSIONS: Blood/serum metal ion concentrations are reliable indicators of abnormal wear processes. Important differences exist however between elements and the blood fraction under study. Future guidelines must take these differences into account.

Surface finish of the Exeter Trauma Stem: a cause for concern?

Recent guidance recommends the use of a well-proven cemented femoral stem for hemiarthroplasty in the management of fractures of the femoral neck, and the Exeter Trauma Stem (ETS) has been suggested as an example of such an implant. The design of this stem was based on the well-proven Exeter Total Hip Replacement stem (ETHRS). This study assessed the surface finish of the ETS in comparison with the ETHRS. Two ETSs and two ETHRSs were examined using a profilometer with a precision of 1 nm and compared with an explanted Exeter Matt stem. The mean roughness average (RA) of the ETSs was approximately ten times higher than that of the ETHRSs (0.235 µm (0.095 to 0.452) versus 0.025 µm (0.011 to 0.059); p < 0.001). The historical Exeter Matt stem roughness measured a mean RA of 0.973 µm (0.658 to 1.159). The change of the polished Exeter stem to a matt surface finish in 1976 resulted in a high stem failure rate. We do not yet know whether the surface differences between ETS and ETHRS will be clinically significant. We propose the inclusion of hemiarthroplasty stems in national joint registries.

Analysis of failed Van Straten LPM proximal interphalangeal prostheses.

The two-piece Van Straten Leuwen Poeschmann Metal (LPM) prosthesis was intended for the proximal interphalangeal joints. However, revision rates of 29% after 19 months were reported, as well as massive osteolysis. Five failed LPM titanium-niobium coated cobalt chromium components were obtained, three distal and two proximal, and subjected to a forensic retrieval analysis. Components were analyzed using a Talysurf contacting profilometer, ZYGO noncontacting profilometer, and environmental-scanning electron microscope. All components were heavily worn. In some regions the titanium-niobium coating had been scratched and penetrated. Elsewhere this coating had been removed where there was minimal scratching, which may have been due to corrosion between the coating and substrate. The osteolysis reported clinically was likely to be linked to the wear debris from the failed titanium-niobium coating and substrate.

Taper junction failure in large-diameter metal-on-metal bearings.

OBJECTIVES: An ongoing prospective study to investigate failing metal-on-metal hip prostheses was commenced at our centre in 2008. We report on the results of the analysis of the first consecutive 126 failed mated total hip prostheses from a single manufacturer. METHODS: Analysis was carried out using highly accurate coordinate measuring to calculate volumetric and linear rates of the articular bearing surfaces and also the surfaces of the taper junctions. The relationship between taper wear rates and a number of variables, including bearing diameter and orientation of the acetabular component, was investigated. RESULTS: The measured rates of wear and distribution of material loss from the taper surfaces appeared to show that the primary factor leading to taper failure is the increased lever arm acting on this junction in contemporary large-diameter metal-on-metal hip replacements. CONCLUSIONS: Our analysis suggests that varus stems, laterally engaging taper systems and larger head diameters all contribute to taper failure.

Challenges associated with using bovine serum in wear testing orthopaedic biopolymers.

For appropriate in vitro wear testing of prostheses and their biomaterials, the choice of lubricant is critical. Bovine serum is the lubricant recommended by several international standards for wear testing artificial joints and their biomaterials because the wear rate and wear mechanisms closely match clinical results of polyethylene bearings. The main problem with the use of bovine serum as a lubricant is protein degradation and precipitation formation, effects that are recognized as having a direct impact on wear processes. Hence, some researchers have questioned the validity of using bovine serum in simulator testing. This paper reviews the various lubricants used in laboratory wear studies and also the properties of the synovial fluid that the lubricant is trying to replicate. It is clear from the literature survey that the composition of bovine-serum-based lubricants does not match that of synovial fluid. In view of this conclusion, it is suggested that there is a need to develop an alternative lubricant that can replace bovine serum.

Accelerating failure rate of the ASR total hip replacement.

There is widespread concern regarding the incidence of adverse soft-tissue reactions after metal-on-metal (MoM) hip replacement. Recent National Joint Registry data have shown clear differences in the rates of failure of different designs of hip resurfacing. Our aim was to update the failure rates related to metal debris for the Articular Surface Replacement (ASR). A total of 505 of these were implanted. Kaplan-Meier analysis showed a failure rate of 25% at six years for the ASR resurfacing and of 48.8% for the ASR total hip replacement (THR). Of 257 patients with a minimum follow-up of two years, 67 (26.1%) had a serum cobalt concentration which was greater than 7 µg/l. Co-ordinate measuring machine analysis of revised components showed that all patients suffering adverse tissue reactions in the resurfacing group had abnormal wear of the bearing surfaces. Six THR patients had relatively low rates of articular wear, but were found to have considerable damage at the trunion-taper interface. Our results suggest that wear at the modular junction is an important factor in the development of adverse tissue reactions after implantation of a large-diameter MoM THR.

Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear.

We sought to establish the incidence of joint failure secondary to adverse reaction to metal debris (ARMD) following metal-on-metal hip resurfacing in a large, three surgeon, multicentre study involving 4226 hips with a follow-up of 10 to 142 months. Three implants were studied: the Articular Surface Replacement; the Birmingham Hip Resurfacing; and the Conserve Plus. Retrieved implants underwent analysis using a co-ordinate measuring machine to determine volumetric wear. There were 58 failures associated with ARMD. The median chromium and cobalt concentrations in the failed group were significantly higher than in the control group (p < 0.001). Survival analysis showed a failure rate in the patients with Articular Surface Replacement of 12.8% [corrected] at five years, compared with < 1% at five years for the Conserve Plus and 1.5% at ten years for the Birmingham Hip Resurfacing. Two ARMD patients had relatively low wear of the retrieved components. Increased wear from the metal-on-metal bearing surface was associated with an increased rate of failure secondary to ARMD. However, the extent of tissue destruction at revision surgery did not appear to be dose-related to the volumetric wear.

Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A consequence of excess wear.

Early failure associated with adverse reactions to metal debris is an emerging problem after hip resurfacing but the exact mechanism is unclear. We analysed our entire series of 660 metal-on-metal resurfacings (Articular Surface Replacement (ASR) and Birmingham Hip Resurfacing (BHR)) and large-bearing ASR total hip replacements, to establish associations with metal debris-related failures. Clinical and radiological outcomes, metal ion levels, explant studies and lymphocyte transformation tests were performed. A total of 17 patients (3.4%) were identified (all ASR bearings) with adverse reactions to metal debris, for which revision was required. This group had significantly smaller components, significantly higher acetabular component anteversion, and significantly higher whole concentrations of blood and joint chromium and cobalt ions than asymptomatic patients did (all p < 0.001). Post-revision lymphocyte transformation tests on this group showed no reactivity to chromium or cobalt ions. Explants from these revisions had greater surface wear than retrievals for uncomplicated fractures. The absence of adverse reactions to metal debris in patients with well-positioned implants usually implies high component wear. Surgeons must consider implant design, expected component size and acetabular component positioning in order to reduce early failures when performing large-bearing metal-on-metal hip resurfacing and replacement.

Blood metal ion concentrations after hip resurfacing arthroplasty: a comparative study of articular surface replacement and Birmingham Hip Resurfacing arthroplasties.

There have been no large comparative studies of the blood levels of metal ions after implantation of commercially available hip resurfacing devices which have taken into account the effects of femoral size and inclination and anteversion of the acetabular component. We present the results in 90 patients with unilateral articular surface replacement (ASR) hip resurfacings (mean time to blood sampling 26 months) and 70 patients with unilateral Birmingham Hip Resurfacing (BHR) implants (mean time 47 months). The whole blood and serum chromium (Cr) and cobalt (Co) concentrations were inversely related to the size of the femoral component in both groups (p < 0.05). Cr and Co were more strongly influenced by the position of the acetabular component in the case of the ASR, with an increase in metal ions observed at inclinations > 45 degrees and anteversion angles of < 10 degrees and > 20 degrees. These levels were only increased in the BHR group when the acetabular component was implanted with an inclination > 55 degrees. A significant relationship was identified between the anteversion of the BHR acetabular component and the levels of Cr and Co (p < 0.05 for Co), with an increase observed at anteversion angles < 10 degrees and > 20 degrees. The median whole blood and serum Cr concentrations of the male ASR patients were significantly lower than those of the BHR men (p < 0.001). This indicates that reduced diametral clearance may equate to a reduction in metal ion concentrations in larger joints with satisfactory orientation of the acetabular component.

Analysis of the mechanism of fracture of silicone metacarpophalangeal prostheses.

Eleven fractured Sutter metacarpophalangeal prostheses were obtained from the hands of three patients. All of the implants had fractured at the junction of the distal stem and the hinge. After visual examination, the fracture faces were prepared and viewed using a scanning electron microscope. These images indicated that fracture was initiated by abrasion on the dorsal aspect of the distal stem of the prostheses, close to the hinge. Crack propagation was shown to be due to a fatigue process. Once a crack started, its direction of travel could be followed, using topographical features common to engineering fracture analyses. Propagation was from radial to ulnar and from dorsal to palmar.