Corrosion at modular junctions of total hip replacements has been identified as a potential threat to implant longevity, resulting in efforts to determine appropriate countermeasures. Visual scoring and volumetric material loss measurements have been useful tools to elucidate various clinical and design factors associated with corrosion damage. However, corrosion involves electron exchange that results in chemical changes to biomedical alloys, and electrochemical assessment may therefore be a more appropriate approach to understand the phenomenon. The purpose of this pilot study was to electrochemically distinguish the severity of corrosion in retrieved femoral heads. A secondary goal was to identify the potential of electrochemical impedance spectroscopy (EIS) as a method to identify different forms of corrosion damage. Twenty femoral heads were identified from a larger study of total hip replacements, obtained as part of an ongoing multi- center IRB-approved retrieval program. Using a previously established 4-point scoring method, components were binned by taper damage: 10 components were identified as having severe damage, 7 with moderate damage and 2 with mild damage. One (1) unimplanted control was included to represent minimal corrosion damage. All components were then characterized using electrochemical impedance spectroscopy under the frequency domain: a 10 mV sinusoidal voltage, ranging from 20 kHz to 2 mHz, was applied to the taper of a femoral head (working electrode) filled with a 1M solution of PBS, a platinum counter electrode and a chlorided silver reference electrode. Absolute impedance at 2 mHz (|Z0.002|), and max phase angle (θ) were assessed relative to taper damage severity. After least-squares fitting of the EIS data to a Randles circuit with a constant phase element, circuit elements: polarization resistance (Rp), CPE-capacitance, and CPE-exponent were also evaluated. The seven (7) most severely corroded components were further examined with scanning electron microscopy to identify corrosion modes. For all statistical analyses, significance was determined at alpha=0.05.Introduction
Methods
Fretting crevice-corrosion (tribocorrosion) of metallic biomaterials is a major concern in orthopedic, spinal, dental and cardiovascular devices1. Stainless steel (i.e., 316L SS) is one alloy that sees extensive use in applications where fretting, crevices and corrosion may be present. While fretting-corrosion of this alloy has been somewhat studied, the concept of fretting-initiating crevice corrosion (FICC), where an initial fretting corrosion process leads to ongoing crevice-corrosion without continued fretting, is less understood. This study investigated the susceptibility of 316L SS to FICC and the role of applied potential on the process. The hypothesis is crevice-corrosion can be induced in 316L SS at potentials well below the pitting potential. A pin-on-disk fretting test system similar to that of Swaminathan et al.2 was employed. Disks were ∼35 mm in diameter and the pin area was ∼500 mm. Samples were polished to 600 mm finish, cleaned with ethanol and distilled water. An Ag/AgCl wire as the reference, a carbon counter electrode and phosphate buffered saline (PBS, pH 7.4, Room T) were used for electrochemical testing. Load was controlled with a dead-weight system, monitored with a six-axis load cell (ATI Inc.). Interfacial motion was captured with a non-contact eddy current sensor (0.5 mm accuracy). Motion and load data acquisition was performed with Labview (National Instruments). Samples were loaded to ∼2 N. The potential per tests was increased from −250 to 250 mV (50 mV increments) with new locations and pins used in each repeat (n=3). Testing incorporated a 1 min rest before fretting (5 min, 1.25 Hz, 60 mm displacement saw tooth pattern). Fretting ceased and the load was held while currents were captured for another 5 min to assess ongoing crevice corrosion.Introduction
Materials and Methods
Mechanically assisted crevice corrosion of modular tapers continues to be a concern in total joint replacements as studies have reported increases in local tissue reactions1. Two surgical factors that may effect taper seating mechanics are seating load magnitude and orientation. In this study 12/14 modular taper junctions were seated over a range of loads and loading orientations. The goals of this study were to assess the effects of load magnitude and orientation on seating load-displacement mechanics and to correlate these to the pull-off load. Ti6Al4V 12/14 tapers and CoCrMo heads were tested axially at four seating load levels (n=5): 1-, 2-, 4- and 8- kN. Three orientation groups were tested at 4 kN (n=5), 0°, 10° and 20°. The load-displacement behavior during testing was captured using data acquisition methods and two non-contact eddy current sensors fixed to the neck, targeting head-neck relative motion (Micro-Epsilon). Loads were ramped (200 N/s) with a servohydraulic system from 0 N to peak load and held for 5s (Instron). Off-axis test samples were oriented in an angled fixture. Displacement and load data were recorded in LabView. Seating displacement was the distance traveled between 50 N and thepeak load. Axial tensile pull-off loads (5 mm/min) were applied until the locking ability of taper junctions failed. Statistical analysis was performed using ANOVA test (P<0.05).Statement of Purpose
Methods
Previous studies of CoCr alloy femoral components for total knee arthroplasty (TKA) have identified 3rd body abrasive wear, and apparent inflammatory cell induced corrosion (ICIC) [1] as potential damage mechanisms. The association between observed surface damage on the femoral condyle and metal ion release into the surrounding tissues is currently unclear. The purpose of this study was to investigate the damage on the bearing surface in TKA femoral components recovered at autopsy and compare the damage to the metal ion concentrations in the synovial fluid. 12 autopsy TKA CoCr femoral components were collected as part of a multi-institutional orthopedic implant retrieval program. The autopsy components included Depuy Synthes Sigma Mobile Bearing (n=1) and PFC (n=1), Stryker Triathlon (n=1) and Scorpio (n=3), and Zimmer Nexgen (n=4) and Natural Knee (n=2). Fluoro scans of all specimens prior to removal was carried out to assure no signs of osteolysis or aseptic loosening were present. Third-body abrasive wear of CoCr was evaluated using a semi-quantitative scoring method similar to the Hood method [2]. ICIC damage was reported as location of affected area and confirmed using a digital optical microscope with 4000X magnification. Synovial fluid was aspirated from the joint capsule prior to removal of the TKA device. The synovial fluid was spun at 1600 rpm for 20 minutes in a centrifuge with the cell pellet removed. The supernatant was analyzed in 1 mL quantities for ICP-MS (inductively coupled plasma mass spectrometry) by Huffman Hazen Laboratories. Data was expressed as ppb.Introduction
Methods
Mechanically assisted crevice corrosion (MACC) of head-neck modular taper junctions is prevalent in virtually all head neck tapers in use today. To date, no clear in vitro tests of design, material or surgical elements of the modular taper system have been reported that show which factors principally affect MACC in these tapers. Possible elements include seating load, head-neck offset, surface roughness, taper engagement length, material combination, angular mismatch, and taper diameter. The goals of this study were to use an incremental fretting corrosion test method1 to assess the above 7 elements using a design of experiments approach. The hypothesis is that only one or two principal factors affect fretting corrosion. A 27-2 design of experiment test (7 factors, ¼ factorial, n=32 total runs, 16 samples per condition per factor) was conducted. Factors included: Assembly Force (100, 4000N), Head Offset (1.5, 12 mm), Taper Locking Position (Mouth, Throat), Stem Taper Length (0.44, 0.54 in), Stem Taper Roughness (Ground, Ridged), Taper Diameter (9/10, 12/14), and Stem Material (CoCrMo, Ti-6Al-4V). The heads were CoCrMo coupled with taper coupons (DePuy Synthes, Warsaw, IN). Test components were assembled wet and seated axially with 100 or 4000N assembly force. The assemblies were immersed in PBS and potentiostatically held at −50mV vs. Ag/AgCl. Incremental cyclic loads were applied vertically to the head at 3Hz until a 4000N maximum load was reached (See Fig. 1). Fretting currents at 4000 N cyclic load were used for comparisons while other parameters, including onset load, subsidence, micromotion and pull off load were also captured. Statistical analysis was performed using Pareto charts and Student's T-tests for single factor comparisons (P < 0.05 was statistically significant).Introduction
Methods
There is considerable interest in the orthopaedic community in understanding the multifactorial process of taper fretting corrosion in total hip arthroplasty (THA). Previous studies have identified some patient and device factors associated with taper damage, including length of implantation, stem flexural rigidity, and head offset. Due to the complexity of this phenomenon, we approached the topic by developing a series of matched cohort studies, each attempting to isolate a single implant design variable, while controlling for confounding factors to the extent possible. We also developed a validated method for measuring material loss in retrieved orthopaedic tapers, which contributed to the creation of a new international standard (ASTM F3129-16). Based on our implant retrieval collection of over 3,000 THAs, we developed independent matched cohort studies to examine (1) the effect of femoral head material (metal vs. ceramic, n=50 per cohort) and (2) stem taper surface finish (smooth vs. microgrooved, n=60 per cohort). Within each individual study, we adjusted for confounding factors by balancing implantation time, stem taper flexural rigidity, offset, and, when possible, head size. We evaluated fretting and corrosion using a four-point semiquantitative score. We also used an out-of-roundness machine (Talyrond 585) to quantify the material loss from the tapers. This method was validated in a series of experiments of controlled material removal on never-implanted components.Introduction
Methods
Recently, our lab has made observations of metal damage patterns from retrieval studies that appeared to be cellular in nature [1]. This type of damage presented on about 74% of the retrieved implants and was attributed to inflammatory cells (termed ICI corrosion) [1]. An alternate hypothesis arose surrounding the use of electrosurgery in total joint arthroplasty (TJA). In TJA, where surgery occurs around metallic devices, the interactions of the high voltage, high frequency current created by an electrosurgical generator and the implant need to be better understood. In order to explore the effects electrosurgical currents have on metal implants, the interaction of a model system of highly polished metal disks and a standard electrosurgical generator (ConMed, Utica, NY) was evaluated in various modes and power settings. The disks were made of CoCrMo or Ti-6Al-4V alloys and were polished to a mirror finish for use and placed directly on the return electrode pad used in patients. Both coagulation and cut modes were evaluated, as well as both monopolar and bipolar configurations in wet and dry conditions using a blade-shaped tip. In wet cases, the disks were wet with phosphate buffered saline prior to the test to simulate body fluids in contact with the implant during current application. In all cases, surface damage was generated on both surfaces and was readily observed as a direct result of the current interacting with the metal (Fig. 1 and 2). Direct contact with the metal, regardless of a dry or wet surface, resulted in pitting and oxide buildup at the contact area. Non-contact activation in proximity to the surface or contact with fluid on the surface caused arcing and created damage that was more widespread over the area of fluid contact with the surface. The damage patterns created on the wetted surface by the electrosurgical unit looked very similar to the patterns we previously attributed to inflammatory cells. More specifically, it produced circular, ruffled areas with centralized pits and occasionally presented trail- and weld-like features (Fig. 2). While these results show that some of the damage previously reported to be from ICI corrosion is indeed the result of electrosurgery, there are still cases in retrievals that cannot be explained by this process and the corrosion reaction to alloys exposed to ROS-based molecules demonstrate significant acceleration of corrosion. Thus, ICI corrosion is still a viable hypothesis. Surgeons utilizing electrosurgical systems in proximity to metallic orthopedic implants need to exercise caution as the discharge of electrical energy through these implants can induce localized surface damage and may result in other adverse effects to the metal implants. Ultimately, we would like to update the community on the nature of the damage we previously reported and more importantly bring to light the possibility of surgeon-induced damage to the implant as a result of electrosurgical methods.
In THA, fretting corrosion at the head-stem taper junction has emerged as a clinical concern that may result in adverse local tissue reactions, even in patients with a metal-on-polyethylene bearing [1]. Taper junctions that employ a ceramic head have demonstrated reduced corrosion at the interface [2]. However, during revision surgery with a well-fixed stem, a titanium sleeve is used in conjunction with a ceramic head to ensure proper fit of the head onto the stem and better stress distribution. In vitro testing has suggested that corrosion is not a concern in sleeved ceramic heads [3]; however, little is known about the in vivo fretting corrosion of the sleeves. The purpose of this study was to investigate fretting corrosion in sleeved ceramic heads. Between 2001 and 2014, 35 sleeved ceramic heads were collected during revision surgery as part of a multi-center retrieval program. The sleeves were all fabricated from titanium alloy and manufactured by 4 companies (CeramTec (n=14), Smith & Nephew (Richards, n=11), Stryker (n=5), and Zimmer (n=5)). The femoral heads were made from 3 ceramics (Alumina (n=7), Zirconia (n=11), and Zirconia-toughened Alumina (n=17)). Sleeve dimensions (length and thickness) were measured using calibrated calipers. Fretting corrosion of the sleeves and available associated stems was scored using a 4-point, semi-quantitative scoring system [4], with 1 being little-to-no damage, and 4 corresponded to severe fretting corrosion. Five sleeves could not be extracted; thus the external surface was not scored.Introduction
Materials and Methods
Recent implant design trends have renewed concerns regarding metal wear debris release from modular connections in THA. Previous studies regarding modular head-neck taper corrosion were largely based on cobalt chrome (CoCr) alloy femoral heads. Comparatively little is known about head-neck taper corrosion with ceramic femoral heads or about how taper angle clearance influences taper corrosion. This study addressed the following research questions: 1) Could ceramic heads mitigate electrochemical processes of taper corrosion compared to CoCr heads? 2) Which factors influence stem taper corrosion with ceramic heads? 3) What is the influence of taper angle clearance on taper corrosion in THA? 100 femoral head-stem pairs were analyzed for evidence of fretting and corrosion. A matched cohort design was employed 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. Fretting corrosion was assessed using a semi-quantitative scoring scale where a score of 1 was given for little to no damage and a score of 4 was given for severe fretting corrosion. The head and trunnion taper angles were measured using a roundness machine (Talyrond 585, Taylor Hobson, UK). Taper angle clearance is defined as the difference between the head and trunnion taper angles.Introduction
Methods
The release of metal debris and ions has raised concerns in joint arthroplasty. In THA metal debris and ions can be generated by wear of metal-on-metal bearing surfaces and corrosion at modular taper interfaces, currently understood to be mechanically assisted crevice corrosion (MACC) [1]. More recently, inflammatory-cell induced corrosion (ICIC) has been identified as a possible source of metal debris and/or ions [2]. Although MACC has been shown to occur at modular junctions in TKA, little is known about the prevalence of other sources. The purpose of this study was to determine the sources of metallic debris and ion release in long-term implanted (in vivo > 15y) TKA femoral components. Specific attention was paid to instances of ICIC as well as damage at the implant-bone interface. 1873 retrieved TKA components were collected from 2002–2013 as part of a multi-center, IRB-approved retrieval program. Of these, 52 CoCr femoral condyles were identified as long term TKA (Average: 17.9±2.8y). These components were predominantly revised for loosening, PE wear and instability. 40/52 of the components were primary surgeries. Components were examined using optical microscopy to confirm the presence of 5 damage mechanisms (polyethylene failure, MACC corrosion of modular tapers, corrosion damage between cement and backside, third-body wear, and ICIC). Third-body wear was evaluated using a semi-quantitative scoring method based on the percentage of damaged area. A score of 1 had minimal damage and a score of 4 corresponded to severe damage. Polyethylene components were scored using the Hood method and CoCr components were scored similarly to quantify metal wear. The total area damaged by ICIC was quantified using photogrammetry. Images were taken using a digital SLR with a calibrated ruler in the same focal plane. Using known pixel dimensions, the ICIC damaged area was calculated.Introduction
Methods
Fretting and corrosion has been identified as a clinical problem in modular metal-on-metal THA, but remains poorly understood in modern THA devices with polyethylene bearings. This study investigates taper damage and if this damage is associated with polyethylene wear. Degradation of modular head-neck tapers was raised as a concern in the 1990s (Gilbert 1993). The incidence of fretting and corrosion among modern, metal-on-polyethylene and ceramic-on-polyethylene THA systems with 36+ mm femoral heads remains poorly understood. Additionally, it is unknown whether metal debris from modular tapers could increase wear rates of highly crosslinked PE (HXLPE) liners. The purpose of this study was to characterise the severity of fretting and corrosion at head-neck modular interfaces in retrieved conventional and HXLPE THA systems and its effect on penetration rates.Summary Statement
Introduction
Degradation of modular head-neck tapers was raised as a concern in the 1990s (Gilbert 1993). The incidence of fretting and corrosion among modern, metal-on-polyethylene and ceramic-on-polyethylene THA systems with 36+ mm femoral heads remains poorly understood. Additionally, it is unknown whether metal debris from modular tapers could increase wear rates of highly crosslinked PE (HXLPE) liners. The purpose of this study was to characterize the severity of fretting and corrosion at head-neck modular interfaces in retrieved conventional and HXLPE THA systems and its effect on penetration rates. 386 CoCr alloy heads from 5 manufacturers were analyzed along with 166 stems (38 with ceramic femoral heads). Metal and ceramic components were cleaned and examined at the head taper and stem taper by two investigators. Scores ranging from 1 (mild) to 4 (severe) were assigned in accordance with the semi-quantitative method adapted from a previously published technique. Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Devices implanted less than 1 year were excluded from this analysis because in the short-term, creep dominates penetration of the head into the liner.Introduction:
Patients & Methods:
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. 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.Background:
Questions/purposes:
Wear debris generation in metal-on-metal (MOM) total hip arthroplasty (THA) has emerged as a compelling issue. In the UK, clinically significant fretting corrosion was reported at head-taper junctions of MOM hip prostheses from a single manufacturer (Langton 2011). This study characterizes the prevalence of fretting and corrosion at various modular interfaces in retrieved MOM THA systems used in the United States. 106 MOM bearing systems were collected between 2003 and 2012 in an NIH-supported, multi-institutional retrieval program. From this collection, 88 modular MOM THA devices were identified, yielding 76 heads and 31 stems (22 modular necks) of 7 different bearing designs (5 manufacturers) for analysis. 10 modular CoCr acetabular liners and 5 corresponding acetabular shells were also examined. Mean age at implantation was 58 years (range, 30–85 years) and implantation time averaged 2.2 ± 1.8 years (range, 0–11.0 years). The predominant revision reason was loosening (n=52). Explants were cleaned and scored at the head taper, stem taper, proximal and distal neck tapers (for modular necks), liner, and shell interfaces in accordance with the semi-quantitative method of Goldberg et al. (2002).Introduction
Methods and Materials
Interfacial membranes collected at revision from 11 failed uncemented Ti-alloy total hip replacements were examined. Particles in the membranes were characterised by electron microscopy, microchemical spectroscopy and particle size analysis. Most were polyethylene and had a mean size of 0.53 micron +/- 0.3. They were similar to the particles seen in the base resin used in the manufacture of the acetabular implants. Relatively few titanium particles were seen. Fragments of bone, stainless steel and silicate were found in small amounts. Most of the polyethylene particles were too small to be seen by light microscopy. Electron microscopy and spectroscopic techniques are required to provide an accurate description of this debris.
