Is the synovial fluid cobalt-to-chromium ratio related to the serum partitioning of metal debris following metal-on-metal hip arthroplasty?

OBJECTIVES: We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr. METHODS: For part A, we included all revision surgeries carried out at our unit with the relevant data, including volumetric wear analysis, joint fluid (JF) Co and Cr concentrations, and ALVAL grade (n = 315). Receiver operating characteristic curves were constructed to assess the reliability of the CoCr JFR in identifying severe ALVAL and/or SOTP. For part B, we included only patients with unilateral prostheses who had given matched serum and whole blood samples for Co and Cr analysis (n = 155). Multiple regression was used to examine the influence of JF concentrations on the serum partitioning of Co and Cr in the blood. RESULTS: A CoCr JFR > 1 showed a specificity of 83% (77% to 88%) and sensitivity of 63% (55% to 70%) for the detection of severe ALVAL and/or SOTP. In patients with CoCr JFRs > 1, the median blood Cr to serum Cr ratio was 0.99, compared with 0.71 in patients with CoCr JFRs < 1 (p < 0.001). Regression analysis demonstrated that the blood Cr to serum Cr value was positively associated with the JF Co concentration (p = 0.011) and inversely related to the JF Cr concentration (p < 0.001). CONCLUSION: Elevations in CoCr JFRs are associated with adverse biological (severe ALVAL) or tribocorrosive processes (SOTP). Comparison of serum Cr with blood Cr concentrations may be a useful additional clinical tool to help to identify these conditions.Cite this article: D. J. Langton, S. Natu, C. F. Harrington, J. G. Bowsher, A. V. F. Nargol. Is the synovial fluid cobalt-to-chromium ratio related to the serum partitioning of metal debris following metal-on-metal hip arthroplasty? Bone Joint Res 2019;8:146-155. DOI: 10.1302/2046-3758.83.BJR-2018-0049.R1.

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.

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.

A simulator study of adverse wear with metal and cement debris contamination in metal-on-metal hip bearings.

OBJECTIVES: Third-body wear is believed to be one trigger for adverse results with metal-on-metal (MOM) bearings. Impingement and subluxation may release metal particles from MOM replacements. We therefore challenged MOM bearings with relevant debris types of cobalt-chrome alloy (CoCr), titanium alloy (Ti6Al4V) and polymethylmethacrylate bone cement (PMMA). METHODS: Cement flakes (PMMA), CoCr and Ti6Al4V particles (size range 5 µm to 400 µm) were run in a MOM wear simulation. Debris allotments (5 mg) were inserted at ten intervals during the five million cycle (5 Mc) test. RESULTS: In a clean test phase (0 Mc to 0.8 Mc), lubricants retained their yellow colour. Addition of metal particles at 0.8 Mc turned lubricants black within the first hour of the test and remained so for the duration, while PMMA particles did not change the colour of the lubricant. Rates of wear with PMMA, CoCr and Ti6Al4V debris averaged 0.3 mm(3)/Mc, 4.1 mm(3)/Mc and 6.4 mm(3)/Mc, respectively. CONCLUSIONS: Metal particles turned simulator lubricants black with rates of wear of MOM bearings an order of magnitude higher than with control PMMA particles. This appeared to model the findings of black, periarticular joint tissues and high CoCr wear in failed MOM replacements. The amount of wear debris produced during a 500 000-cycle interval of gait was 30 to 50 times greater than the weight of triggering particle allotment, indicating that MOM bearings were extremely sensitive to third-body wear. Cite this article: Bone Joint Res 2015;4:29-37.

What is a "normal" wear pattern for metal-on-metal hip bearings?

In addition to classical run-in and steady-state wear phases, metal-on-metal (MOM) hip bearings have encountered "runaway wear" (RAW) trends in simulator studies. This puzzling behavior has resulted in 2- to 19-fold wear increases compared with other apparently "identical" bearings. MOM bearings have shown five identifiable RAW wear patterns in joint simulators; therefore, additional descriptive terms were used here to indicate various observed patterns, for example, "breakaway wear" (BAW), which was defined as a higher wear trend that recovers to steady-state wear. As these trends commonly occur for MOM, this raises the question of what can be considered "normal" behavior or "abnormal"? In an effort to identify possible causes for this behavior, the current study investigated six Co-Cr bearings, which closely matched with respect to geometrical tolerances. Despite close control of design and test variables, BAW occurred in 30% of the MOM bearings, producing a threefold wear increase above otherwise identical MOM bearings within the same group. The majority of the BAW (85%) occurred on the cup side and was validated by growth of wear scars and concentrations of metal ions. One bearing that showed continuing BAW at 5 Mc revealed a cup that was 50% smoother than other cups whereas its mating head was 50% rougher, thus signifying that highly polished areas were sites of the highest MOM wear. The two BAW bearings with high wear showed the greatest conformity at 5 Mc, in apparent contradistinction to classical lubrication theory.

"Severe" wear challenge to 36 mm mechanically enhanced highly crosslinked polyethylene hip liners.

Our purpose was to compare the wear performance of mechanically enhanced 5Mrad highly crosslinked polyethylene (MEP, ArComXL) hip liners to (control) 3Mrad UHMWPE liners (ArCom) in 36 mm head size. As a more severe synergy of clinically relevant test models, we contrasted wear with custom roughened Co-Cr surfaces (Ra 500 nm) to the standard pristine Co-Cr heads (Ra < 20 nm) using a severe microseparation test mode in our hip simulator. We adopted a previously published model to estimate potential biological activity. On new Co-Cr heads, the MEP liners showed a 47% reduction in volumetric wear a 13% reduction in wear particle size and a 27% reduction in Functional Biological Activity (FBA) compared to our control. On rough Co-Cr heads, the MEP liners showed little advantage in terms of volumetric wear compared with the control. However, the MEP liners overall showed a 38% reduction in FBA compared to the control owing to a larger volume fraction of larger particles. Thus overall the MEP liners appeared to offer advantages in terms of reduced FBA indices.

'Severe' wear challenge to 'as-cast' and 'double heat-treated' large-diameter metal-on-metal hip bearings.

The wear generation of double-heat-treated and as-cast large-diameter metal-on-metal (MOM) hip bearings was investigated using standard- and 'severe'-gait simulations. The test hypothesis was that double heat treatment would change MOM hip wear compared with the as-cast condition. Two groups of high-carbon MOM bearings of 40 mm diameter were manufactured and subjected to either hot isostatic pressing (HIP) and solution annealing (SA) or no heat treatment (as cast). The results showed no statistical difference between the two groups under both running-in and steady state conditions. Even under the most 'severe'-gait simulation published to date, the mean volumetric wear rates were 2.9 and 3.9 mm3 per 10(6) cycles for the HIP-SA and as-cast bearings respectively, showing a ten-fold increase in wear compared with walking. These differences were not statistically different; therefore our hypothesis was negated. Changes in alloy microstructure do not appear to influence the wear behaviour of high-carbon cast MOM articulations with similar chemical compositions. This is in sharp contrast with the published significance of bearing diameter and radial clearance on the wear of MOM hip bearings.

Metal-on-metal hip simulator study of increased wear particle surface area due to 'severe' patient activity.

This study investigated changes in metal-on-metal (MOM) hip wear and wear particle characteristics arising from a more aggressive patient activity level compared with normal walking. The test hypothesis was that 'severe'-gait conditions will change wear, wear particle sizes, and morphology owing to a decline in joint lubrication. Four carbon MOM hip bearings 40 mm high were subjected to normal-walking and fast-jogging simulations in an orbital hip joint simulator with 25 per cent alpha-calf serum as a lubricant. Co-Cr-Mo wear particles were extracted using an enzymatic method, and prolate ellipsoid equations were used to estimate particle volume and surface area. Fast-jogging simulations generated a sevenfold increase in volumetric wear, a 33 per cent increase in mean wear particle size, and a threefold increase in the number of larger (needle) particles compared with walking. This resulted in a twentyfold increase in total wear particle surface area per 10(6) cycles compared with walking, thereby confirming our hypothesis. The clinical significance of this result suggests that highly active MOM patients may exhibit greater ion release than less active patients.