What Is the Incidence of Cobalt-Chromium Damage Modes on the Bearing Surface of Contemporary Femoral Component Designs for Total Knee Arthroplasty?

BACKGROUND: The purpose of this study was to determine the incidence of metal release in contemporary total knee arthroplasty and the patient-related factors associated with this release. METHODS: In total, 256 retrieved cobalt-chromium femoral components were collected through a multi-institutional orthopedic implant retrieval program (implanted: 1-15 years). Implants were mainly revised for loosening (84/256), instability (62/256), and infection (46/256). Third-body damage was assessed using a semiquantitative scoring method. Microscale electro-corrosion damage (MECD) was evaluated using digital optical microscopy. Radii of curvature were measured from representative components to calculate anterior-posterior and medial-lateral ratios. Femoral component surface roughness was measured using a white light interferometer. Using a multivariable linear model, associations between damage score, implant, and patient factors were tested. Spearman's ρ correlation tests were performed to determine the association between roughness measurements and damage score. RESULTS: Mild to severe damage was observed in 52% (134/256) of the components. In the multivariable linear model, anterior-posterior ratio (ß = -8.07; P < .001), loosening (ß = -0.52; P = .006), and patient weight (ß = 0.01; P = .007) were associated with damage score. Suspected MECD damage was observed in 82% (209/256) of components. The Ra value (ρ = 0.196; P = .002) and Rq value (ρ = 0.157; P = .012) increased as the damage score increased. CONCLUSION: The findings of this retrieval study support that similar damage mechanisms exist in contemporary and long-term total knee arthroplasty devices. Additionally, we observed associations between loosening, anterior-posterior conformity, and patient weight with increased surface damage.

Corrosion Damage and Wear Mechanisms in Long-Term Retrieved CoCr Femoral Components for Total Knee Arthroplasty.

BACKGROUND: Metal debris and ion release has raised concerns in joint arthroplasty. The purpose of this study was to characterize the sources of metallic ions and particulate debris released from long-term (in vivo >15 years) total knee arthroplasty femoral components. METHODS: A total of 52 CoCr femoral condyles were identified as having been implanted for more than 15 years. The femoral components were examined for incidence of 5 types of damage (metal-on-metal wear due to historical polyethylene insert failure, mechanically assisted crevice corrosion at taper interfaces, cement interface corrosion, third-body abrasive wear, and inflammatory cell-induced corrosion [ICIC]). Third-body abrasive wear was evaluated using the Hood method for polyethylene components and a similar method quantifying surface damage of the femoral condyle was used. The total area damaged by ICIC was quantified using digital photogrammetry. RESULTS: Surface damage associated with corrosion and/or CoCr debris release was identified in 51 (98%) CoCr femoral components. Five types of damage were identified: 98% of femoral components exhibited third-body abrasive wear (mostly observed as scratching, n = 51/52), 29% of femoral components exhibited ICIC damage (n = 15/52), 41% exhibited cement interface damage (n = 11/27), 17% exhibited metal-on-metal wear after wear-through of the polyethylene insert (n = 9/52), and 50% of the modular femoral components exhibited mechanically assisted crevice corrosion taper damage (n = 2/4). The total ICIC-damaged area was an average of 0.11 ± 0.12 mm2 (range: 0.01-0.46 mm2). CONCLUSION: Although implant damage in total knee arthroplasty is typically reported with regard to the polyethylene insert, the results of this study demonstrate that abrasive and corrosive damage occurs on the CoCr femoral condyle in vivo.

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.

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.

Direct in vivo inflammatory cell-induced corrosion of CoCrMo alloy orthopedic implant surfaces.

Cobalt-chromium-molybdenum (CoCrMo) alloy, used for over five decades in orthopedic implants, may corrode and release wear debris into the body during use. These degradation products may stimulate immune and inflammatory responses in vivo. We report here on evidence of direct inflammatory cell-induced corrosion of human implanted and retrieved CoCrMo implant surfaces. Corrosion morphology on CoCrMo implant surfaces, in unique and characteristic patterns, and the presence of cellular remnants and biological materials intimately entwined with the corrosion indicates direct cellular attack under the cell membrane region of adhered and/or migrating inflammatory cells. Evidence supports a Fenton-like reaction mechanism driving corrosion in which reactive oxygen species are the major driver of corrosion. Using in vitro tests, large increases in corrosion susceptibility of CoCrMo were seen (40-100 fold) when immersed in phosphate buffered saline solutions modified with hydrogen peroxide and hydrochloric acid to represent the chemistry under inflammatory cells. This discovery raises significant new questions about the clinical consequences of such corrosion interactions, the role of patient inflammatory reactions, and the detailed mechanisms at play.

Can pin-on-disk testing be used to assess the wear performance of retrieved UHMWPE components for total joint arthroplasty?

The objective of this study was to assess the suitability of using multidirectional pin-on-disk (POD) testing to characterize wear behavior of retrieved ultrahigh molecular weight polyethylene (UHMWPE). The POD wear behavior of 25 UHMWPE components, retrieved after 10 years in vivo, was compared with 25 that were shelf aged for 10-15 years in their original packaging. Components were gamma sterilized (25-40 kGy) in an air or reduced oxygen (inert) package. 9 mm diameter pins were fabricated from each component and evaluated against CoCr disks using a super-CTPOD with 100 stations under physiologically relevant, multidirectional loading conditions. Bovine serum (20 g/L protein concentration) was used as lubricant. Volumetric wear rates were found to vary based on the aging environment, as well as sterilization environment. Volumetric wear rates were the lowest for the pins in the gamma inert, shelf aged cohort. These results support the utility of using modern, multidirectional POD testing with a physiologic lubricant as a novel method for evaluating wear properties of retrieved UHMWPE components. The data also supported the hypothesis that wear rates of gamma-inert liners were lower than gamma-air liners for both retrieved and shelf aging conditions. However, this difference was not statistically significant for the retrieved condition.

Advances in zirconia toughened alumina biomaterials for total joint replacement.

The objective of this article is to provide an up-to-date overview of zirconia-toughened alumina (ZTA) components used in total hip arthroplasties. The structure, mechanical properties, and available data regarding the clinical performance of ZTA are summarized. The advancements that have been made in understanding the in vivo performance of ZTA are investigated. This article concludes with a discussion of gaps in the literature related to ceramic biomaterials and avenues for future research.

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.

Evaluation of physical and mechanical properties of porous poly (ethylene glycol)-co-(L-lactic acid) hydrogels during degradation.

Porous hydrogels of poly(ethylene glycol) (PEG) have been shown to facilitate vascularized tissue formation. However, PEG hydrogels exhibit limited degradation under physiological conditions which hinders their ultimate applicability for tissue engineering therapies. Introduction of poly(L-lactic acid) (PLLA) chains into the PEG backbone results in copolymers that exhibit degradation via hydrolysis that can be controlled, in part, by the copolymer conditions. In this study, porous, PEG-PLLA hydrogels were generated by solvent casting/particulate leaching and photopolymerization. The influence of polymer conditions on hydrogel architecture, degradation and mechanical properties was investigated. Autofluorescence exhibited by the hydrogels allowed for three-dimensional, non-destructive monitoring of hydrogel structure under fully swelled conditions. The initial pore size depended on particulate size but not polymer concentration, while degradation time was dependent on polymer concentration. Compressive modulus was a function of polymer concentration and decreased as the hydrogels degraded. Interestingly, pore size did not vary during degradation contrary to what has been observed in other polymer systems. These results provide a technique for generating porous, degradable PEG-PLLA hydrogels and insight into how the degradation, structure, and mechanical properties depend on synthesis conditions.

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.