Total knee arthroplasty with a rotating hinge knee with carbon-fibre-reinforced (CFR)-PEEK as an alternative bushing material with enhanced creep, wear and fatigue behaviour has been clinically established [1-4]. The objective of our study was to compare results from in vitro biotribological characterisation to ex vivo findings on a retrievals. A modified in vitro wear simulation based on ISO 14243-1 was performed for 5 million cycles on rotating hinge knee (RHK) designs (EnduRo®) out of cobalt-chromium and ZrN-multilayer ceramic coating. The rotational & flexion axles-bushings and the flanges are made of CFR-PEEK with 30% polyacrylonitrile fibre content. Analysis of 12 retrieved EnduRo® RHK systems in cobalt-chromium and ZrN-multilayer in regard to loosening torques, microscopic surface analysis, distinction between different wear modes and classification with a modified HOOD-score has been performed. For the RHK design with the polyethylene gliding surface and bushings and flanges made out of CFR-PEEK, a cumulative volumetric wear was measured to be 12.9±3.95 mm. 3. in articulation to cobalt-chromium and 1.3±0.21 mm. 3. to ZrN-multilayer coating - a significant 9.9-fold decrease (p=0.0072). For the CFR-PEEK flexion bushing and flanges the volumetric wear rates were 2.3±0.48 mm. 3. /million cycles (cobalt-chromium) and 0.21±0.02 mm. 3. /million cycles (ZrN-multilayer) (p=0.0016). The 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which is in accordance to the time in vivo of 12–60 months of the retrieved RHK components [5]. The main wear modes were comparable between retrievals and in vitro specimens, whereby the size of affected area on the retrieved components showed a higher variation. For the EnduRo® RHK design the findings on retrieved implants demonstrate the high suitability of CFR-PEEK as a biomaterial for highly loaded bearings, such as RHK bushings and flanges in articulation to cobalt-chromium and to a ZrN-multilayer coating

Introduction. The use of Additive Manufacturing (AM) to 3D print titanium implants is becoming widespread in orthopaedics, particularly in producing cementless porous acetabular components that are either custom-made or off-the-shelf; the primary design rationale for this is enhanced bony fixation by matching the porosity of bone. Analysis of these retrieved components can help us understand their performance; in this study we introduce a non-destructive method of the retrieval analysis of 3D printed implants. Material and methods. We examined 11 retrieved 3D printed acetabular cups divided into two groups: “custom-made” (n = 4) and “off-the-shelf” (n = 7). A macroscopic visual analysis was initially performed to measure the area of tissue ongrowth. High resolution imaging of each component was captured using a micro-CT scanner and 3D reconstructed models were used to assess clinically relevant morphometric features of the porous structure: porosity, porous structure thickness, pore size and strut thickness. Optical microscopy was also used as a comparison with microCT results. Surface morphology and elemental composition of the implants were investigated with a Scanning Electron Microscope (SEM) coupled with an Energy Dispersive X-ray Spectroscope (EDS). Statistical analysis was performed to evaluate possible differences between the two groups. Results. We found a spread of tissue coverage, median of 81% (23 – 95), with a trend with time in situ. Custom implants showed a higher spread of porosity, with median value of 74.11% (67.94 – 81.01), due to the presence of differently designed porous areas. Off-the-shelf cups had median porosity of 72.49% (66.67 – 73.07), but there was no significant difference between the two groups (p = 0.164). There was a significant difference in the thickness of the porous structure of the two groups, which were 3.918 mm (3.688 – 4.102) and 1.289 mm (1.235 – 1.364), respectively (p = 0.006). SEM output showed specific morphological features of 3D printed object; EDS analysis suggested that no chemical modifications occurred in vivo, with elemental ratios (Ti/Al = 14; Ti/V = 21; Al/V = 1.51) comparable to previously published results. Conclusion. This is one of the first retrieval studies of 3D printed orthopaedic implants. We introduced a method for the investigation of these components and micro-CT scanning enabled the non-destructive assessment of the porous structure. This work represents the first step in understanding the performance of 3D printed implants

Introduction. During revision surgery with a well-fixed stem, a titanium sleeve can be used in conjunction with a ceramic head to achieve better stress distribution across the taper surface. Previous studies have observed that the use of a ceramic head can mitigate the extent of corrosion damage at the taper. Moreover, in vitro testing suggests that corrosion is not a concern in sleeved ceramic heads [1]; 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. Materials and Methods. Thirty sleeved ceramic heads (Biolox Option: CeramTec) were collected during revision surgery as part of a multi-center retrieval program. The sleeves were used in conjunction with a zirconia-toughened alumina femoral head. The femoral heads and sleeves were implanted between 0.0 and 3.25 years (0.8±0.9, Figure 1). The implants were revised predominantly for instability (n=14), infection (n=7), and loosening (n=5). Fifty percent of the retrievals were implanted during a primary surgery, while 50% had a history of a prior revision surgery. Fretting corrosion was scored using a previously described 4-point, semi-quantitative scoring system proposed by Higgs [2]. Results. Among the sleeved ceramic heads, mild-to-moderate fretting corrosion scores (Score = 2–3) were observed in 96% of internal tapers, 26% of external tapers, and 82% of the stems. On the internal taper surface, 5 sleeves had moderate fretting corrosion data (Score = 3, Figure 2). None of sleeves had severe (Score = 4) at any taper surface. Fretting corrosion scores were higher at the internal taper surface than the external taper. Implantation time was the main predictor of increased fretting-corrosion of the external sleeve tapers. Discussion. For the sleeved ceramic heads, we found that fretting corrosion can occur in these components, particularly on the internal surface of the sleeve. However, the fretting corrosion scores were predominantly mild, and lower than fretting scores of CoCr heads in metal on polyethylene bearings. Because the sleeves are Ti alloy, the corrosion products are considered to be less cytotoxic than Co and Cr. The primary limitation to this study is the short-term follow-up of these retrievals. As the fretting corrosion process is often associated with in vivo duration, future studies with longer-term implants are necessary to elucidate the long-term performance of these devices

Introduction. In an effort to provide a TKA bearing material that balances resistance to wear, mechanical failure and oxidation, manufacturers introduced antioxidant polyethylene. In many designs, this is accomplished through pre-blending the polymer with the antioxidant before consolidation and radiation crosslinking. This study reports the wear performance (in terms of thickness change) of a hindered phenol (PBHP) UHMWPE from analysis of an early series of knee retrievals and explores these questions: 1) What is early-time performance of this new bearing material? 2) Is there a difference in performance between fixed and mobile bearings in this design? 3) How does quantitative surface analysis help understand performance at the insert-tray modular interface?. Methods. A series of 100 consecutive Attune™ knee inserts (DePuy Synthes, Warsaw, IN) received at revision by an IRB approved retrieval laboratory between September 2014 and March 2019 were investigated. In vivo duration was 0–52 months. Both the fixed bearing design (n=74) and the rotating platform mobile bearing design (n=26) were included. Dimensional change was determined by measurement of each insert and compared to the as-manufactured dimensions, provided by the manufacturer. The insert-tray interfaces under the loaded bearing zones were analyzed with light interferometry using an optical surface profiler (NewView™ 7300, Zygo, Middlefield, CT). Statistical analyses to explore relationships between measured variables were conducted using SPSS. Results. Mean total through-thickness change of the inserts was 0.052 mm. Mean rate of thickness change for all inserts having in vivo duration > 12 months was 0.038 mm/year (fixed bearing 0.042, mobile bearing 0.029 mm/year). The rate of thickness change for all inserts showed a decreasing trend with duration that was not statistically significant, (rho -.244, p=.094); however, the mobile bearing cohort alone showed a significant decrease in thickness change rate with duration (rho= −.659; p=.014). Surface roughness (Sa) of the distal surface of the UHMWPE inserts under the bearing areas averaged 1.24 µm (range 0.12 – 8.53) and peak-to-valley height (PV) averaged 27.1 µm (range 4 – 95). Sa and PV both showed a decreasing trend with duration in vivo in the mobile bearing inserts, but that trend did not reach statistical significance (p= 0.05 criterion). Neither Sa nor PV showed correlation with measured thickness change. Discussion. This study indicates that the rate of thickness change of a relatively new antioxidant cross-linked bearing material is very similar to other reported wear rates of crosslinked knee inserts. Lower wear rate of mobile bearing inserts compared to fixed bearings also is consistent with earlier published studies. Direct comparison between quantitative thickness change and objective, quantitative surface metrology on the same series brings new information to the arena of measuring and reporting “wear” of UHMWPE and underscores the importance of the distinction between visual damage and actual thinning of the bearing. The systematic surface analysis of the modular interfaces showing that surface roughness (Sa) and total damage feature topography (PV) trend downward with in vivo duration of mobile bearings supports the hypothesis that relative motion at that interface may ‘polish out’ the surface topography over time. For any figures or tables, please contact authors directly

Hemi shoulder arthroplasty is an attractive treatment for shoulder arthritis in particular if the natural glenoid is still intact. However, comparing the clinical results of hemi and total shoulder arthroplasty clearly shows lower survival for the hemi arthroplasty. One of the most common reasons for revision surgery is gleniod erosion, where the cartilage or bone is worn of. Aim of the current study was to analyse if the metallic articular surface of retrieved hemi shoulder arthroplasty is different from new implants. We hypothesized that the surface roughness will increased due the articulation and that metallic wear is detectable on the implants. Twelve retrieved and three brand new hemi shoulder arthroplasty were included. The surface roughness (Ra, Rz, Rmax, Rsk) was measured on different sites of the surface (center of the head and at the edge). The implants were further measured using a coordinate measuring machine to gain information on volumetric wear and geometrical alterations. Compared to new implants the surface roughness on the retrievals was significantly increased (Tab. 1), except for skewness. Although the roughness parameters within the retrieval group were generally higher at the center of the head compared to the edge, this difference was not significant. Apart from form deviations no volumetric wear was detectable on the heads (Fig. 1). The current results indicate that the metallic articular implant surface changes in vivo and that the material is hurt due to the articulation against the softer cartilage or bone. Although it can't be finally clarified by that study, to what extend the higher roughness is taking part in the process of the clinically observed erosion of the gleniod, it can be assumed that an increased roughness is disadvantageous. Possibly, the observed surface alterations won't occur clinically with harder materiel (e.g. ceramic), but this even needs to be validated

Introduction. Previous studies of retrieved CoCr alloy femoral heads have identified imprinting of the stem taper surface features onto the interior head bore, leading researchers to hypothesize that stem taper microgrooves may influence taper corrosion. However, little is known about the role of stem taper surface morphology on the magnitude of in vivo corrosion damage. We designed a matched cohort retrieval study to examine this issue. Methods. From a multi-institutional retrieval collection of over 3,000 THAs, 120 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 60 CoCr head-stem pairs with a smooth stem taper were matched with 60 CoCr head-stem pairs having a micro-grooved surface, based on implantation time, flexural rigidity, apparent length of taper engagement, and head size. This study was adequately powered to detect a difference of 0.5 in corrosion scores between the two cohorts, with a power of 82% and 95% confidence. Both cohorts included CoCr and Ti-6-4 alloy femoral stems. A high precision roundness machine (Talyrond 585, Taylor Hobson, UK) was used to measure surface morphology and categorize the stem tapers into smooth vs. micro-grooved categories. Fretting and corrosion damage at the head/neck junction was characterized using a modified semi-quantitative adapted from the Goldberg method by three independent observers. This method separated corrosion damage into four visually determined categories: minimal, mild, moderate and severe damage. Results. Mild to severe damage (Fretting Corrosion Score ≥ 2) was observed in 75% of the 120 CoCr femoral heads (78% of the heads mated with micro-grooved stems (47/60), Fig. 1A) and 72% of the heads mated with smooth stems (43/60, Fig 1B). Fretting and corrosion damage was not significantly different between the two cohorts when evaluated at the CoCr femoral head bore (p =0.105, Mann Whitney test, Fig. 2A) or the male stem tapers (p =0.428, Fig. 2B). No implant or patient factors were associated with fretting corrosion; corrosion scores were not significantly associated with stem alloy in the two cohorts (p=0.669, Mann-Whitney test). Discussion. The results of this matched cohort retrieval study do not support the hypothesis that taper surfaces with micro-grooved stems exhibit increased in vivo fretting corrosion. We accounted for implant, patient, and clinical factors that may influence in vivo taper corrosion with the matched cohort design and by post hoc statistical analyses. However, this study is limited by the semi-quantitative method used for evaluating damage in these components. Therefore, additional research will be necessary to quantify the volume of metal release from these two cohorts. To view tables/figures, please contact authors directly

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion / taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in the form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from well functioning small diameter, with poorly functioning LHMOMTHR's using the above technique. Method. 3 groups of retrieval tapers were analysed (Group 1: 28 mm CoCr heads from well functioning MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs revised for failure secondary to adverse reaction to metal debris (n=5); Gp 3 (control): 28 mm heads from well functioning metal on Polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. The Redlux profiling of modular head tapers involves a non direct method whereby an imprint of the inside surface of a modular head is taken, and this is subsequently scanned by an optical non contact sensor using dedicated equipment [1]. The wear was also measured on the bearing surface [1]. RedLux profiling of the tapers produced a taper angle and 3D surface maps. The taper angles obtained with the Redlux method were compared to those obtained using CMM measurement on 3 parts. The Redlux profiling, including imprints, was also repeated 3 times to gauge potential errors. Results. There was no difference in mean 12/14 taper angles between groups. There was no difference in volumetric and linear wear at the bearing surface between groups. Only the LHMOMs showed transfer of pattern from the stem to the internal head taper, with clear demarcation of the contact and damaged area between head taper and stem trunnion (see figure 1 – interpretation of head taper surface features demonstrated using Redlux optical imaging). 3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group. These appearances were not seen in tapers from small diameter MOM and MOP THRs (see Figure 2). Discussion. Differences in appearance of the taper surface between poorly functioning LHMOMTHRs and well functioning MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure. Further work is required to fully qualify the Redlux method capabilities, and to understand the origin of the damage seen on those tapers, and the possible partial contribution of damage caused during retrieval

Objective. We explanted NeuFlex metacarpophalangeal (MP) joint prostheses to identify common features, such as position of fracture, and thus better understand the reasons for implant failure. Methods. Explanted NeuFlex MP joint prostheses were retrieved as part of an-ongoing implant retrieval programme. Following revision MP joint surgery the implants were cleaned and sent for assessment. Ethical advice was sought but not required. The explants were photographed. The position of fracture, if any, was noted. Patient demographics were recorded. Results. Thirty NeuFlex MP explants were available. Seven (23%) were not fractured. Eleven explants (37%) had fractured at the hinge; nine (30%) had fractured at the junction of the distal stem and hinge; and three (10%) had fractured at both the hinge and distal stem. NeuFlex MP joint explants ranged in size from 0 to 40. Smaller sizes were retrieved from smaller fingers; larger implants came from the middle and index fingers. The age at revision ranged from 43 to 81 (median 58) years. Time in vivo ranged from 6 to 120 (median 58.5) months. All but two implants were obtained from rheumatoid joints, the remainder had osteoarthritis. Discolouration of some explants had occurred; other explants appeared to show no colour change. Conclusions. This is the first report of the position of fracture of NeuFlex explants. It is also the largest report of silicone arthroplasty explants. The majority (77%) had fractured. Nine (30%) NeuFlex explants had fractured at the junction of the distal stem and hinge; the typical position seen with Swanson and Sutter/Avanta MP joint explants. Eleven (37%) fractured across the hinge; this has not previously been reported although has been seen in in vitro testing. The hinge is thinner than the hinge-stem junction so may be at risk of more rapid failure, however the median time in vivo for hinge fractures was 63 months as opposed to 54 months for fractures at the distal stem. Intriguingly, 3 (10%) NeuFlex explants suffered fractures both at the hinge and at the junction of the distal stem and hinge which has also never been reported previously. Fracture at the junction of the distal stem and hinge shows the importance of subluxing forces in rheumatoid MP joints and therefore suggests these need to be mitigated as much as possible. Fracture across the hinge could indicate this as a position which could be increased in thickness, to increase the time taken to fracture, although there may be a concomitant increase in stiffness of the implant. With improved designs, patients might suffer fewer or later failures. The latest Norwegian Arthroplasty Registry report shows that revision MP joint arthroplasties accounted for 42% of all MP joint replacement operations in 2015. Therefore, this is an important area where opportunities exist to reduce revision rates

Introduction. Contemporary total knee systems accommodate for differential sizing between femoral and tibial components to allow surgeons to control soft tissue balancing and optimize rotation. One method some manufacturers use to allow differential sizing involves maintaining coronal articular congruency with a single radius of curvature throughout sizes while clipping the medial-lateral width, called a single coronal geometry system. Registry data show a 20% higher revision rate when the tibial component is smaller than the femur (downsizing) in the DePuy PFC system, a single coronal system, possibly from increased stresses from edge loading or varying articular congruency. We examined a different single coronal geometry knee system, Smith & Nephew Genesis II, to determine if edge loading is present in downsized tibial components by measuring area and location of deviation of the polyethylene articular surface damage. Methods. 45 Genesis II posterior-stabilized polyethylene inserts (12 matched and 33 downsized tibial components) were CT scanned. 3D reconstructions were registered to corresponding pristine component reconstructions, and 3D deviation maps of the retrieved articular surfaces relative to the pristine surfaces were created. Each map was exported as a point cloud to a custom MATLAB code to calculate the area and weighted center of deviation of the articular surfaces. An iterative k-means clustering algorithm was used to isolate regions of deviation, and a shrink-wrap algorithm was applied to calculate their areas. The area of deviation was calculated as the sum of all regions of deviation and was normalized to the area of the articular surface. The location of deviation was described using the weighted center of deviation and the location of maximum deviation on the articular surfaces relative to the center of the post (Fig. 1). Pearson product moment correlations were conducted to examine the correlation between length of implantation (LOI) and the medial and lateral areas of deviation for all specimens, matched components, and downsized components. Results. The mean LOIs for downsized and matched tibial components were not different (36±28 months vs 46±26 months, p=0.24). Areas of deviation for the medial and lateral sides for both downsized and matched components increased with LOI (p<0.001). Medial and lateral sides of matched retrievals were not different in location of maximum deviation, maximum deviation, and weighted center of deviation (p>0.4). The matched and downsized retrievals did not have different centers of deviation in the medial-lateral direction, maximum deviations, or locations of maximum deviations (p>0.1). Discussion. Our results suggest that downsizing the tibial component in the Genesis II system, a single coronal geometry system, did not affect the area or location of deviation on the articular surface. Overall, the weighted center of deviation remained close to the dwell point and did not change as a function of tibial downsizing. However, we saw deviation patterns biased peripherally for inserts with low LOI in both matched and downsized cohorts. With increasing LOI, the deviation expanded to cover the majority of the available articular surface. Our results suggest the need to further examine this and other systems determine the effects of differential sizing. For figures/tables, please contact authors directly.

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion/taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from small diameter with LHMOMTHR's. 3 groups of retrieval tapers were analysed (Group 1: 28mm CoCr heads from MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs (n=5); Group 3: 28mm heads from metal on polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. Both bearing surfaces and head tapers were measured for wear using the Redlux profiling non contact measurement system. Measurements included taper angle and 3D surface maps. Taper angles obtained with the Redlux method were compared to those obtained using CMM measurement on 3 parts. The Redlux profiling, including imprints, was also repeated 3 times to gauge potential errors. There was no difference in mean 12/14 taper angles between groups. There was no difference in volumetric and linear wear at the bearing surface between groups. Only the LHMOMs showed transfer of pattern from the stem to the internal head taper, with clear demarcation of the contact and damaged area between head taper and stem trunnion. 3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group alone. Discussion: Differences in appearance of the taper surface between LHMOMTHRs and MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure. Further work is required to fully qualify the Redlux method capabilities

One of serious issues in total hip arthroplasty (THA) is the osteolysis which results in aseptic loosening caused by the wear particles from a polyethylene (PE) acetabular cup. In addition, oxidation degradation of PE cup resulting in the fracture or the severe wear caused by the reduction of mechanical properties in vivo is also the issue. The oxidation degradation is considered to be induced by residual free radicals generated by gamma-ray irradiation for cross-linking to reduce wear or for sterilization. In this study, (1) wear property, (2) oxidation degradation of retrieved PE and highly cross-linked PE (CLPE) cups against alumina ceramic femoral heads, and (3) the correlation between those properties were evaluated. The radiographic wear of six conventional PE cups with the mean follow-up of 19.1–23.3 years and 60 CLPE cups with the mean follow-up of 3.1–9.1 years were measured by a non-radiostereometric analysis method (Vectorworks. ®. 10.5 software package). As a retrieval analysis, 26 retrieved acetabular cups were evaluated; 16 cups were ethylene oxide gas-sterilized conventional PE cups with clinical use for 16.0–24.9 years and 10 cups were gamma-ray-sterilized CLPE cups with clinical use for 0.9–6.7 years. The linear and the volumetric wear were measured using a three-dimensional (3D) coordinate measurement machine. The shapes of unworn and worn surfaces with 15- and 30-point intervals, respectively, were measured. Oxidation degradation of the surface, sub-surface and inner for both worn and unworn parts of the retrieved cups was measured using a Fourier-transform infrared (FT-IR) spectroscopy. Oxidation indices were calculated using the peak at 1740 cm. −1. and 1370 cm. −1. according to ASTM F2012. In the radiographic analysis, the linear wear rate of CLPE cups was significantly lower than that of conventional PE cups [Fig. 1]. In the retrieval analysis, the linear wear rate of CLPE cups (mean: 0.07 mm/year) showed a 51% reduction (p = 0.002) compared to conventional PE cups (mean: 0.14 mm/year) [Fig. 2]. The retrieval and the radiographic analysis for both conventional PE and CLPE cups showed similar results (p = 0.7 and 0.1, respectively). Maximum oxidation indices for CLPE cups were similar to those of conventional PE cups regardless of the difference of clinical duration [Fig. 3]. This result is different from in vivo wear, which increases as the clinical duration. For both conventional PE and CLPE cups, the oxidation indices of subsurface were higher than those for surface. The worn parts showed higher oxidation indices than those for unworn parts. From the results, even when the free radicals were so few or absent, the oxidation degradation would be induced in vivo. In conclusion, the wear resistance for CLPE cups was greater than that for conventional PE cups from both radiographic and retrieval analyses. The in vivo oxidation degradation might not be caused by only residual free radicals. It was found that oxidation degradation of PE cups when used with alumina ceramic femoral heads is not correlated to their wear properties

Aseptic loosening of the glenoid after total shoulder replacement is a challenging problem to manage clinically. In the right circumstances, arthroscopic retrieval of loose polyethylene glenoids can be a valuable tool in the shoulder surgeon's repertoire for dealing with this uncommon problem. The purpose of this talk is to demonstrate the technique for arthroscopic removal of a loose glenoid and review the clinical circumstances where this procedure may play a valuable role

Introduction. This study was performed to investigate the failure mechanism of one specific hip arthroplasty cup design that has shown a high clinical failure rate. The aim of this study was to identify general design problems of this polyethylene inlay. Material and Methods. 55 consecutive retrievals of a cementless screw ring (Mecron) were collected. In any case a 32 mm ceramic head was used. All implants failed due to aseptic loosening. The follow-up of the implants was 3 to 16 years. We recorded backside wear, fatigue of the polyethylene at the flanges on the outer rim and at the cup opening (32 mm inner diameter). To assess the deformation of the inlay, the smallest and the median diameter of the cup opening were measured using a 3 dimensional coordinate measuring machine (Multisensor, Mahr, Germany). Results. 90% of the explants showed signs of wear on the backside of the inlay. Another typical and so far not described alteration was collar fatigue in 68%. 38% of the inlays showed rim creep: Examples for Backside wear, collar fatigue and rim creep are illustrated in Fig. 1. 90% had a diameter of 32.1 mm or less, and even 46% had a diameter less than 32 mm. Discussion. The investigated design is at the lower limit of the allowed machining tolerance of the cup opening (32 + 0.1 mm) and has no additional clearance (which some manufacturers add). It seems that the inlays yield at the dome because of the viscoelastic properties of polyethylene and the open dome area of the attached screw ring. This leads to excessive wear at the dome area and it triggers a “brake drum” effect at the cup opening. Thereby torsional stresses at the implant bone interface increase which lead to failure of the implant. To avoid this type of failure, PE inlays should have enough clearance at the cup opening and the inlay should have dome contact to the closed metal shell

Increased modularity of total hip arthroplasty components has occurred, with theoretical advantages and disadvantages. Recent literature indicates the potential for elevated revision rates of modular neck systems and the potential for metallosis and ALVAL (Aseptic Lymphocyte dominated Vasculitis Associated Lesion) formation at the modular neck/stem site. Retrieval analysis of one modular neck implant design including SEM (Scanning Electron Microscopy) assessment was done and correlated to FEA (Finite Element Analysis) as well as clinical features of patient demographics, implant and laboratory analysis. Correlation of the consistent corrosion locations to FEA indicates that the material and design features of this system may result in a biomechanical reason for failure. The stem aspect of the modular neck/stem junction may be at particular risk

Introduction. 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. Methods and Materials. 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). Results. Fretting and corrosion were observed on 68/76 (89%) head tapers, 21/31 (68%) stem tapers, 15/22 (68%) proximal modular neck tapers, 20/22 (91%) distal modular neck tapers, 10/10 (100%) modular liners and 5/5 (100%) modular shells. Scores were lower at proximal stem tapers than within the head tapers (p = 0.001) but were positively correlated (ρ = 0.56, p = 0.001). At the head-neck interface, significantly more damage was noted on head tapers of devices with modular necks (p<0.001). At the neck-stem interface, damage to modular necks was localized at the curved medial and lateral surfaces. A significant correlation was observed between implantation time and corrosion/fretting score at this region (ρ = 0.78, p < 0.001). Damage was noted at all shell-liner interfaces, manifested primarily as scratching with discoloration on the backside rim of liners and circular fretting patterns on shells. Discussion. These results support the inclusion of fretting and corrosion evaluation in standardized MOM retrieval inspection protocols. Adaptation of the method developed by Goldberg and colleagues is suitable for the variety of modular connections in contemporary MOM THA implants, which may incorporate modular femoral and/or acetabular components. Further quantitative assessment of wear at modular interfaces of retrieved MOM devices is therefore warranted

Introduction. Detailed analysis of retrieved total hip replacements (THRs) is valuable for assessing implant and material successes and failures. Reduction of bearing wear and corrosion and fretting of the head-neck trunnion is essential to implant durability and patient health. This research quantifies and characterizes taper and bearing surface damage on retrieved oxidized zirconium THRs. Methods. Initially, 11 retrieved oxidized zirconium femoral heads were examined along with their associated femoral stems. Relevant patient and retrieval data was collected from clinical charts and radiographs. Taper corrosion (Figure 1) and fretting damage (Figure 2) scoring was performed following the Dyrkacz [1] method. A coordinate measuring machine was used to obtain a detailed surface map of the male and female taper surfaces. Taper surface maps were best-fit with an idealized cone followed by volume subtraction to quantify the amount of material removed as a result of fretting and corrosion processes. Scanning electron microscopy was performed on select samples to identify specific damage modes. Unique surface bumps were noted on the articular surface of select femoral heads (Figure 3). Seventeen femoral heads were added to the analysis specifically for identification of these bumps. Articular surfaces were searched under SEM magnification and bumps were identified and counted. Parametric statistical correlations were performed with SAS v9.3. Results. Mean patient age was 61 years (Range: 35–95) with mean implantation period being 2.0 years (Range: 0.1–11.4) and mean body mass index of 29 kg/m. 2. (Range: 22–46). Revision for infection (n=11), peri-prosthetic fracture (n=5) and dislocation (n=5) were the main reasons for revision. Mean corrosion damage scores were 2.0 and 3.6 (head, neck) while mean fretting damage scores were 8.5 and 5.8 (head, neck). Fretting damage score was weakly correlated with implantation period (p=0.07) while corrosion damage score was not. Mean corrosion and fretting volume measured 0.40 mm. 3. and 0.87 mm. 3. (head, neck). Volume of corrosion and fretting damage did not correlate with implantation period; however neck volume correlated with inclination angle of the acetabular cup (p<0.01). Bearing diameter was not found to correlate with corrosion and fretting damage score or volume. The unique surface bumps were identified in 12 of 28 samples, with 3 samples having <10 bumps. Presence of these bumps did not appear to be related to bearing diameter, implantation period, or any damage metrics. Conclusion. Fretting damage was found to correlate with implantation period, suggesting that is a continuous in vivo process; however, this was not found for corrosion damage. Fretting damage volume correlated with acetabular cup angle; however, this may be coincidence as only 8 samples were included in the analysis. Overall, our corrosion damage scores (2.0–3.6) were lower than previously published values for 28mm & 36mm cobalt-chrome heads (4.5–13.1) [1]. However, our fretting damage scores (5.8–8.5) were higher than previously published (2.8–4.4) [1]. Greater fretting damage on the oxidized zirconium heads may be explained by the softer zirconium alloy compared to that of cobalt-chromium. Further subsurface investigation of the surface bumps is underway using a focused ion beam mill

Introduction. 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). Methods. 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. Results. In the first study, the ceramic cohort exhibited a 92% reduction in cumulative volumetric loss from both the head and neck taper surfaces compared to the CoCr cohort (p < 0.001). In the CoCr cohort, there was greater material loss from femoral head tapers as compared with stem tapers (p < 0.0001). There was also a correlation between visual scoring and volumetric material loss (ρ = 0.67, p < 0.01). In the second study, taper damage was not different between the smooth and microgrooved taper cohorts when evaluated at the head bore (p=0.14) or the stem tapers (p=0.35). There was also no difference in material loss between the most damaged CoCr heads in the two cohorts (p>0.05). Conclusions. Our findings suggest that fretting and corrosion damage and material loss from the stem taper are mitigated, and on the head taper, eliminated with the use of a ceramic vs. metal femoral head. We also found that fretting and corrosion damage was insensitive to differences in stem taper surface finish and the presence of microgrooves. 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 within the large range of material loss observed at the taper surfaces with high fretting-corrosion scores. Thus, for moderate to severely damaged conical tapers, direct measurement is necessary. A drawback of a matched cohort approach is that a large retrieval collection is necessary to effectively match an investigational group of implants with an appropriate control cohort. Notwithstanding this limitation, the matched cohort approach has been an effective approach to study the complex multifactorial problem of taper fretting and corrosion

Introduction. Thermally treated 1st generation highly crosslinked polyethylenes (HXLPE) have demonstrated reduced penetration and osteolysis rates, however, concerns still remain with respect to oxidative stability and mechanical properties of these materials. To address these concerns, manufacturers have introduced the use of antioxidants to quench free radicals while maintaining the mechanical properties of the HXLPE. Two common antioxidants are α-tocopherol (Vitamin-E) and pentaerythritol tetrakis (PBHP). These may be either mixed prior to consolidation, or diffused throughout the polymer after consolidation and irradiation. In vitrostudies have shown that these materials are oxidatively stable and have improved mechanical properties compared to 1st generation HXLPEs; however, few studies have investigated the in vivo performance of anti-oxidant stabilized HXLPE. The purpose of this study was to investigate the revision reasons, oxidation, and mechanical properties of retrieved short-term anti-oxidant HXLPE. Methods. Between 2010 and 2015, 73 anti-oxidant HXLPE components were collected as a part of an IRB approved, multi-institutional retrieval analysis program during routine revision surgery. Of the seventy-three components, 30 (41%) were acetabular liners, whereas, 43 were tibial inserts. The components were fabricated from three different materials: Vitamin-E Diffused HXLPE (n=30; E1, Biomet), Vitamin-E Blended (n = 41; Vivacit-E, Zimmer) and PBHP blended (n = 2, AOX, DePuy). The hip and knee components were implanted for 0.7 ± 0.8 years (Range: 0.0–2.25 years) and 0.8 ± 1.1 years (Range: 0.0–4.5 years), respectively. Implantation time, patient weight, age, gender, and activity levels were similar between hip and knee components (Table 1). For oxidation analysis, thin slices (∼200μm) were taken from medial condyle and central eminence of the tibial inserts or the superior/inferior axis from hip components. The slices were boiled in heptane for six hours to extract lipids absorbed in vivo. 3-millimeter FTIR line scans were taken perpendicular to the surface of interest, according to the ASTM F2102. Mechanical properties were assessed using the small punch test (ASTM F2183). Forty-three explants were available for destructive testing. Results. The predominant revision reasons were loosening, instability, and infection (Figure 1). Oxidation was low in both the hip and knee components (Mean OI≤0.1; Figure 2). For both tibial inserts and acetabular liners, there was no correlation between implantation time and oxidation indices (p>0.05). In the tibial inserts, the AP face had slightly higher oxidation indices than the articulating surface (Mean difference = 0.04; p=0.03). There was no difference in ultimate load between hips and knees at the surface (p=0.14) or the subsurface (p=0.38). Discussion. This study analyzed the revision reasons, oxidative stability, and mechanical properties of short-term retrieved 2nd generation HXLPE. The observations of this study show that anti-oxidant infused HXLPE exhibited low oxidative indices (Mean OI<0.1). There was no difference observed in the mechanical properties of these materials between hip and knee applications. However, this study is limited by short implantation times. This is unavoidable because the materials have only recently become clinically available. The data presented serves as a benchmark for future studies when longer-term retrieved implants become available

Background:. Polyethylene wear in total knee arthroplasty (TKA) is influenced by patient, surgeon and implant factors. The objective of this study is to assess the effect of limb alignment, implant position and joint line position on the pattern of wear in posterior stabilized (PS) tibial inserts. Methods:. This was a retrieval analysis of 83 PS liners collected from patients who underwent revision surgery from 1999 to 2011. Inserts were divided into 16 zones and a microscopic analysis of surface damage was carried out. We determined overall damage with a scoring system. Pre-revisions radiographs were reviewed and analyzed for correlation with the wear profile. Results:. The mean age was 73 years old (range 45 to 96 years old) and the mean duration of implantation was 3.5 years (range 0.1 to 10.6 years). The most common reason for revision was infection (71%, 59 of 83 liners), followed by aseptic loosening (6%, 5 of 83 liners) and instability (6%, 5 of 83 liners). The most common mode of wear was burnishing, followed by abrasion and pitting. The total damage score was significantly higher in knees with postoperative varus alignment more than 3 degrees (p = 0.03). Postoperative varus alignment was associated with significantly more wear in the medial compartment (p = 0.03). The total damage score to the post was significantly more in knees with joint line elevation more than 5 mm (9.7 ± 3.9, compared to 6.5 ± 3.7 in knees with less joint line elevation) (p = 0.05). The most commonly affected compartment was the medial compartment. Conclusion:. Limb malalignment and implant malposition resulted in more wear in PS TKA

Introduction:. First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1. st. generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2. nd. generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2. nd. generation HLXPEs. The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA. Methods:. 251 2. nd. Generation HXLPE hip and knee components were consecutively retrieved during revision surgeries and continuously analyzed in a prospective, IRB approved, multicenter study. 123 acetabular liners (Implanted 1.2y; Range 0–5.0y) and 117 tibial inserts (Implanted 1.6y; Range 0–5.8y) were highly crosslinked and annealed in 3 sequential steps (X3). Five acetabular liners (Implanted 0.6y; Range 0–2.0y) and six tibial inserts (Implanted 1.3y; Range 0.5–1.8y) were diffused with Vitamin E (E1). Patient information was collected from medical records (Table 1). Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Surface damage of tibial components was assessed using the Hood method. Thin sections were taken from the acetabular liners (along the superior/inferior axis) and the tibial components (along the medial condyle and central spine) for oxidation analysis and analyzed according to ASTM 2102. Mechanical behavior was assessed via the small punch test (ASTM 2183). Results:. The liners and tibial components fabricated from both HXLPEs were revised predominantly for loosening, instability, and infection (Figure 1). The average penetration rate for the Sequentially Annealed group was low (PR = 0.045 mm/yr). Pitting, scratching and burnishing were the predominant damage mechanisms of the tibial inserts within both material groups, with no evidence of delamination. Oxidation indices were low (Mean OI≤0.3) and similar between liners and inserts of the Sequentially Annealed components at the bearing and backside surface (Figure 2, p ≥ 0.15). Oxidation was positively correlated with implantation time at the bearing surface of the Sequentially Annealed groups (Rho > 0.29, p < 0.005). The Ultimate Load of the Sequentially Annealed acetabular liners was statistically higher than the tibial components (p < 0.001), however the mean difference was minimal (∼6N). Discussion:. This study evaluated the properties of 2. nd. generation HXLPEs used in THA and TKA. Sequentially Annealed liners had penetration rates comparable with 1. st. generation HXLPEs. While oxidation was low for both sequentially annealed and Vitamin E HXLPEs, we were able to detect regional variations in the oxidative in the sequentially annealed cohort. Longer-term retrievals are necessary to fully assess the oxidative stability of Vitamin E diffused HXLPE used in TKA and THA