Is There Material Loss at the Conical Junctions of Modular Components for Total Knee Arthroplasty?

BACKGROUND: Clinical concern exists regarding fretting corrosion and material loss from taper junctions in orthopedic devices, with previous research focusing on the modular components from total hip arthroplasty. Comparatively little has been published regarding the fretting corrosion and material loss in modular knee devices. The purpose of this study is to evaluate fretting corrosion damage and quantify material loss for conical total knee arthroplasty taper interfaces. METHODS: Stem tapers of 166 retrieved modular knee devices were evaluated for fretting corrosion using a semiquantitative scoring method. High precision profilometry was then used to determine volumetric material loss and maximum wear depth for a subset of 37 components (implanted for 0.25-18.76 years). Scanning electron microscopy and energy-dispersive X-ray spectroscopy were used to characterize the observed damage. RESULTS: Mild to severe fretting corrosion was observed on the majority of tapers, with 23% receiving a maximum visually determined damage score of 4. The median rate of volumetric material loss was 0.11 mm3/y (range 0.00-0.76) for femoral components (both cone and bore taper surfaces combined) and 0.01 mm3 (range 0.00-8.10) for tibial components. Greater rates of material loss were associated with mixed metal pairings. There was a strong correlation between visual fretting corrosion score and calculated material loss (ρ = 0.68, P < .001). Scanning electron microscopy revealed varying degrees of scratching, wear, fretting corrosion, and instances of cracking with morphology not consistent with fretting corrosion, wear, or fatigue. CONCLUSION: Although visual evidence of fretting corrosion damage was prevalent and correlated with taper material loss, the measured volumetric material loss was low compared with prior reports from total hip arthroplasty.

Do Stem Taper Microgrooves Influence Taper Corrosion in Total Hip Arthroplasty? A Matched Cohort Retrieval Study.

BACKGROUND: Previous studies identified imprinting of the stem morphology onto the interior head bore, leading researchers to hypothesize an influence of taper topography on mechanically assisted crevice corrosion. The purpose of this study was to analyze whether microgrooved stem tapers result in greater fretting corrosion damage than smooth stem tapers. METHODS: A matched cohort of 120 retrieved head-stem pairs from metal-on-polyethylene bearings was created controlling for implantation time, flexural rigidity, apparent length of engagement, and head size. There were 2 groups of 60 heads each, mated with either smooth or microgrooved stem tapers. A high-precision roundness machine was used to measure and categorize the surface morphology. Fretting corrosion damage at the head-neck junction was characterized using the Higgs-Goldberg scoring method. Fourteen of the most damaged heads were analyzed for the maximum depth of material loss and focused ion beam cross-sectioned to view oxide and base metal. RESULTS: Fretting corrosion damage was not different between the 2 cohorts at the femoral head (P = .14, Mann-Whitney) or stem tapers (P = .35). There was no difference in the maximum depths of material loss between the cohorts (P = .71). Cross-sectioning revealed contact damage, signs of micro-motion, and chromium-rich oxide layers in both cohorts. Microgroove imprinting did not appear to have a different effect on the fretting corrosion behavior. CONCLUSION: The results of this matched cohort retrieval study do not support the hypothesis that taper surfaces with microgrooved stems exhibit increased in vivo fretting corrosion damage or material release.

The Biotribology of PEEK-on-HXLPE Bearings Is Comparable to Traditional Bearings on a Multidirectional Pin-on-disk Tester.

BACKGROUND: All-polymer bearings involving polyetheretherketone (PEEK) have been proposed for orthopaedic applications because they may reduce stress shielding, reduce weight of the implants, reduce wear and risk of osteolysis, and prevent release of metal ions by replacing the metal articulating components. Little is known about the biotribology of all-polymer PEEK bearings, including the effects of cross-shear, which are relevant for implant longevity, especially in the hip, and increased temperature that may affect lubricant proteins and, hence, lubrication in the joint. QUESTIONS/PURPOSES: Using pin-on-disk in vitro testing, we asked: (1) Can all-polymer bearing couples involving PEEK have a comparable or lower wear rate than highly crosslinked UHMWPE (HXLPE) on CoCr bearing couples? (2) Is the wear rate of PEEK bearing couples affected by the amount of cross-shear? (3) Is there a difference in wear mechanism and surface morphology for all-polymer bearing surfaces compared with UHMWPE (HXLPE) on CoCr? METHODS: We simultaneously tested a total of 100 pin-on-disk couples (n = 10 per bearing couple) consisting of three traditional metal-on-UHMWPE and seven polymer-on-polymer bearings for 2 million cycles under physiologically relevant conditions and in accordance with ASTM F732. Using analysis of variance, we analyzed the effect of bearing surface topography and cross-shear on wear rate. The changes in surface topography were evaluated using optical microscopy. Sample size was sufficient to provide 80% power to detect a difference of 1.4 mm3/MC in average wear rates of bearing couples. RESULTS: The combined wear rates of all-polymer bearing couples were not different than traditional bearing couples. With the numbers available, the PEEK and HXLPE bearing couple had a mean wear rate (WR: mean ± SD) of 0.9 ± 1.1 mm3/MC (95% confidence interval [CI], 0.2-1.5 mm3/MC), which was not different than the wear rate of the CoCr and HXLPE bearing couple (1.6 ± 2.0 mm3/MC; 95% CI, 0.4-2.8 mm3/MC; mean difference = 0.73 mm3/MC, p = 0.36). Bearing couples with PEEK reinforced with a carbon fiber (CFR-PEEK) counterface had higher wear rates (14.5 ± 15.1 mm3/MC; 95% CI, 9.1-20.0 mm3/MC) than bearing couples with a PEEK (5.1 ± 3.7 mm3/MC; 95% CI, 3.7-6.4 mm3/MC) or CoCr (4.1 ± 2.7 mm3/MC; 95% CI, 3.2-5.1 mm3/MC) counterface (mean difference = 9.5 mm3/MC, p < 0.001; and mean difference = 10.4 mm3/MC, p < 0.001, respectively). PEEK and HXLPE were insensitive to the cross-shear scenario in the contact mechanics (WR: 0.3 ± 0.1 mm3/MC for PEEK pins [95% CI, 0.2-0.3 mm3/MC] [representing full cross-shear condition] and 0.0 ± 1.0 mm3/MC for PEEK disks [95% CI, -0.5 to 0.5 mm3/MC] [representing limited cross-shear condition], mean difference = 0.3 mm3/MC, p = 0.23; WR: 1.3 ± 1.0 mm3/MC for HXLPE pins [95% CI, 0.7-1.9 mm3/MC] [full cross-shear] and 2.1 ± 2.2 mm3/MC for HXLPE disks [95% CI, 0.8-3.3 mm3/MC] [limited cross-shear], mean difference = 0.8 mm3/MC, p = 0.24). Qualitatively, the surface morphology of UHMWPE appeared similar with PEEK or CoCr as a counterface, although it had a rougher appearance when coupled with carbon fiber-reinforced PEEK. No transfer film was detected on the specimens. CONCLUSIONS: Our in vitro pin-on-disk data suggest that all-polymer bearings, especially PEEK-on-HXLPE bearing couples, may represent a viable alternative to traditional bearings with respect to their wear performance. Our results warrant further testing of all-polymer bearing couples in physiologically relevant joint simulator tests. CLINICAL RELEVANCE: The in vitro pin-on-disk wear resistance of all-polymer bearings incorporating PEEK-on-HXLPE warrants further investigation using joint simulator testing for their validation as useful, metal-free alternatives to traditional CoCr-on-HXLPE bearings for use in orthopaedic applications.

Ceramic Heads Decrease Metal Release Caused by Head-taper Fretting and Corrosion.

BACKGROUND: Metal release resulting from taper fretting and corrosion is a clinical concern, because wear and corrosion products may stimulate adverse local tissue reactions. Unimodular hip arthroplasties have a conical taper between the femoral head (head bore taper) and the femoral stem (stem cone taper). The use of ceramic heads has been suggested as a way of reducing the generation of wear and corrosion products from the head bore/stem cone taper junction. A previous semiquantitative study found that ceramic heads had less visual evidence of fretting-corrosion damage compared with CoCr heads; but, to our knowledge, no studies have quantified the volumetric material loss from the head bore and stem cone tapers of a matched cohort of ceramic and metal heads. QUESTIONS/PURPOSES: We asked: (1) Do ceramic heads result in less volume of material loss at the head-stem junction compared with CoCr heads; (2) do stem cone tapers have less volumetric material loss compared with CoCr head bore tapers; (3) do visual fretting-corrosion scores correlate with volumetric material loss; and (4) are device, patient, or intraoperative factors associated with volumetric material loss? METHODS: A quantitative method was developed to estimate volumetric material loss from the head and stem taper in previously matched cohorts of 50 ceramic and 50 CoCr head-stem pairs retrieved during revision surgery for causes not related to adverse reactions to metal particles. The cohorts were matched according to (1) implantation time, (2) stem flexural rigidity, and (3) lateral offset. Fretting corrosion was assessed visually using a previously published four-point, semiquantitative scoring system. The volumetric loss was measured using a precision roundness machine. Using 24 equally spaced axial traces, the volumetric loss was estimated using a linear least squares fit to interpolate the as-manufactured surfaces. The results of this analysis were considered in the context of device (taper angle clearance, head size, head offset, lateral offset, stem material, and stem surface finish) and patient factors that were obtained from the patients' operative records (implantation time, age at insertion, activity level, and BMI). RESULTS: The cumulative volumetric material losses estimated for the ceramic cohort had a median of 0.0 mm(3) per year (range, 0.0-0.4 mm(3)). The cumulative volumetric material losses estimated for the CoCr cohort had a median of 0.1 mm(3) per year (range, 0.0-8.8 mm(3)). An order of magnitude reduction in volumetric material loss was found when a ceramic head was used instead of a CoCr head (p < 0.0001). In the CoCr cohort, the femoral head bore tapers had a median material loss of 0.02 mm(3) (range, 0.0-8.7 mm(3)) and the stem cone tapers had a median material loss of 0.0 mm(3) (range, 0.0-0.32 mm(3)/year). There was greater material loss from femoral head bore tapers compared with stem cone tapers in the CoCr cohort (p < 0.001). There was a positive correlation between visual scoring and volumetric material loss (Spearman's ρ = 0.67, p < 0.01). Although visual scoring was effective for preliminary screening to separate tapers with no or mild damage from tapers with moderate to severe damage, it was not capable of discriminating in the large range of material loss observed at the taper surfaces with moderate to severe fretting-corrosion damage, indicated with a score of 3 or 4. We observed no correlations between volumetric material loss and device and patient factors. CONCLUSIONS: The majority of estimated material loss from the head bore-stem cone junctions resulting from taper fretting and corrosion was from the CoCr head bore tapers as opposed to the stem cone tapers. Additionally, the total material loss from the ceramic cohort showed a reduction in the amount of metal released by an order of magnitude compared with the CoCr cohort. CLINICAL RELEVANCE: We found that ceramic femoral heads may be an effective means by which to reduce metal release caused by taper fretting and corrosion at the head bore-stem cone modular interface in THAs.

Does Metal Transfer Differ on Retrieved Ceramic and CoCr Femoral Heads?

Metal transfer has been observed on retrieved THA femoral heads for both CoCr and ceramic bearing materials. In vitro wear testing has shown increased wear to polyethylene acetabular liners with the presence of metal transfer. This study sought to investigate the extent of metal transfer on the bearing surface of CoCr and ceramic femoral heads and identify prevalent morphologies. Three bearing couple cohorts: M-PE (n = 50), C-PE (n = 35), and C-C (n = 15), were derived from two previously matched collections (n = 50/group) of CoCr and ceramic femoral heads. From the three cohorts, 75% of the femoral heads showed visual evidence of metal transfer. These femoral heads were analyzed using direct measurement, digital photogrammetry, and white light interferometry. Surface area coverage and curved median surface area were similar among the three cohorts. The most prevalent metal transfer patterns observed were random stripes (n = 21/75), longitudinal stripes (n = 17/75), and random patches (n = 13/75). Metal transfer arc length was shorter in the M-PE cohort. Understanding the morphology of metal transfer may be useful for more realistic recreation of metal transfer in in vitro pin-on-disk and joint simulators studies.

Is there material loss at the backside taper in modular CoCr acetabular liners?

BACKGROUND: Metal wear and corrosion products generated by hip replacements have been linked to adverse local tissue reactions. Recent investigations of the stem/head taper junction have identified this modular interface as another possible source of metal debris; however, little is known regarding other modular metallic interfaces, their ability to produce metal debris, and possibly to provide insight in the mechanisms that produce metal debris. QUESTIONS/PURPOSES: We asked three questions: (1) can we develop a reliable method to estimate volumetric material loss from the backside taper of modular metal-on-metal liners, (2) do backside tapers of modular metal-on-metal liners show a quantifiable volumetric material loss, and, if so, (3) how do regions of quantitatively identified material loss correspond to visual and microscopic investigations of surface damage? METHODS: Twenty-one cobalt-chromium (CoCr) liners of one design and manufacturer were collected through an institutional review board-approved retrieval program. All liners were collected during revision surgeries, where the primary revision reason was loosening (n=11). A roundness machine measured 144 axial profiles equally spaced about the circumference of the taper region near the rim to estimate volume and depth of material loss. Sensitivity and repeatability analyses were performed. Additionally, visual and scanning electron microscopy investigations were done for three liners. RESULTS: Our measurement method was found to be reproducible. The sensitivity (how dependent measurement results are on experimental parameters) and repeatability (how consistent results are between measurements) analyses confirmed that component alignment had no apparent effect (weak correlation, R2=0.04) on estimated volumetric material loss calculations. Liners were shown to have a quantifiable material loss (maximum=1.7 mm3). Visual investigations of the liner surface could identify pristine surfaces as as-manufactured regions, but could misidentify discoloration as a possible region of material loss. Scanning electron microscopy more accurately distinguished between as-manufactured and damaged regions of the taper. CONCLUSIONS: The roundness machine has been used to develop a repeatable method for characterizing material loss; future work comparing a gravimetric standard with estimations of material loss determined from the roundness machine may show the accuracy and effectiveness of this method. Liners show rates of material loss that compare with those reported for other taper junctions. Visual inspection alone may misidentify as-manufactured regions as regions of material loss. CLINICAL RELEVANCE: This study identifies the acetabular liner/shell interface in modular metal-on-metal devices as a potential source of metal wear or corrosion products. The relation between metal debris and clinical performance, regardless of the type of bearing couple, is a concern for clinicians. Therefore, it is important to characterize every type of modular junction to understand the quantity, location, and mechanism(s) of material loss.

Do ceramic femoral heads reduce taper fretting corrosion in hip arthroplasty? A retrieval study.

BACKGROUND: Previous studies regarding modular head-neck taper corrosion were largely based on cobalt chrome (CoCr) alloy femoral heads. Less is known about head-neck taper corrosion with ceramic femoral heads. QUESTIONS/PURPOSES: We asked (1) whether ceramic heads resulted in less taper corrosion than CoCr heads; (2) what device and patient factors influence taper fretting corrosion; and (3) whether the mechanism of taper fretting corrosion in ceramic heads differs from that in CoCr heads. METHODS: One hundred femoral head-stem pairs were analyzed for evidence of fretting and corrosion using a visual scoring technique based on the severity and extent of fretting and corrosion damage observed at the taper. A matched cohort design was used in which 50 ceramic head-stem pairs were matched with 50 CoCr head-stem pairs based on implantation time, lateral offset, stem design, and flexural rigidity. RESULTS: Fretting and corrosion scores were lower for the stems in the ceramic head cohort (p=0.03). Stem alloy (p=0.004) and lower stem flexural rigidity (Spearman's rho=-0.32, p=0.02) predicted stem fretting and corrosion damage in the ceramic head cohort but not in the metal head cohort. The mechanism of mechanically assisted crevice corrosion was similar in both cohorts although in the case of ceramic femoral heads, only one of the two surfaces (the male metal taper) engaged in the oxide abrasion and repassivation process. CONCLUSIONS: The results suggest that by using a ceramic femoral head, CoCr fretting and corrosion from the modular head-neck taper may be mitigated but not eliminated. CLINICAL RELEVANCE: The findings of this study support further study of the role of ceramic heads in potentially reducing femoral taper corrosion.

Does Taper Angle Clearance Influence Fretting and Corrosion Damage at the Head-Stem Interface? A Matched Cohort Retrieval Study.

Previous studies have speculated that modular taper design may have an effect on the corrosion and material loss at the taper surfaces. We present a novel method to measure taper angle for retrieved head taper and stem trunnions using a roundness machine (Talyrond 585, Taylor Hobson, UK). We also investigated the relationship between taper angle clearance and visual fretting-corrosion score at the taper-trunnion junction using a matched cohort study of 50 ceramic and 50 metal head-stem pairs. In this study, no correlation was observed between the taper angle clearance and the visual fretting-corrosion scores in either the ceramic or the metal cohorts.

Edge loading in metal-on-metal hips: low clearance is a new risk factor.

The revision rate of large head metal-on-metal and resurfacing hips are significantly higher than conventional total hip replacements. The revision of these components has been linked to high wear caused by edge loading; which occurs when the head-cup contact patch extends over the cup rim. There are two current explanations for this; first, there is loss of entrainment of synovial fluid resulting in breakdown of the lubricating film and second, edge loading results in a large local increase in contact pressure and consequent film thickness reduction at the cup rim, which causes an increase in wear. This paper develops a method to calculate the distance between the joint reaction force vector and the cup rim--the contact patch centre to rim (CPCR) distance. However, the critical distance for the risk of edge loading is the distance from the contact patch edge to rim (CPER) distance. An analysis of explanted hip components, divided into edge worn and non-edge-worn components showed that there was no statistical difference in CPCR values, but the CPER value was significantly lower for edge worn hips. Low clearance hips, which have a more conformal contact, have a larger diameter contact patch and thus are more at risk of edge loading for similarly positioned hips.