In the retrieval analysis of explanted hip joints, the estimation of wear volume and visualization of wear pattern are commonly used to evaluate in-vivo performance. While many studies report wear volumes from explanted hips, it is important to understand the limitations of these estimates including the sources and magnitude of uncertainty of the reported results. This study builds on a previous uncertainty analysis by Carmignato et al. to quantify the magnitude of uncertainty caused by the assumption that the as-manufactured shape of an explanted hip component is a perfect sphere. Synthetic data sets representing idealized measurements of spheroidal explants (prolate, oblate and pinched) with a nominal diameter of 50 mm were generated. These data sets represent the shape and magnitude of form deviations observed for explanted hip components (Figure 1). Data were simulated for either unworn components or those with a known volume and magnitude of wear simulated to represent 5 µm penetration of a 49.90 mm femoral head into an acetabular cup (Table 1). The volume of wear and wear pattern were estimated using a custom Matlab script developed for analysis of metrology data from explanted hip joints. This script fits a least squares sphere to data points in unworn, as manufactured regions of the surface to estimate the as-manufactured shape of the component. The diameter of the best fit sphere, and wear volume were compared to the known wear depths and volumes from the synthetic datasets. The results showed that the Matlab script estimated a wear volume of up to 1.4 mm3 for an unworn cup with a radial deviation of 10 µm. The maximum error of 13.3 mm3 was for a pinched cup with wear at the pole. The complete results are shown in Table 2. In some cases with aspherical form deviations, the least squares sphere fitted to the synthetic data was displaced in the Z direction with respect to the origin of the spheroid and the radius of the least squares sphere was outside the range of the principal radii of the spheroid. For instance, in case 5, the center was shifted 22 µm vertically from the mathematical center. The results from this study show that the magnitude of uncertainty due to form deviations on wear volume varies depending on the shape and magnitude of the form deviations and in some cases was greater than 10 mm3. A further important finding is that in some instances, the diameter and center of the least squares sphere fitted to the unworn regions may not be consistent with the mathematical radius and center of the synthetic data. This may have important implications for the “reverse engineering” of the as-manufactured dimensions from worn explanted hip joints.
Figure 1 Graphical depiction of a) synthetic data set, b) deviation map of a hemispherical acetabular cup with simulated wear, c) deviation map of a prolate spheroid with simulated wear at rim with color bar set to ±5 microns, d) deviation map of pinched ellipsoid with simulated wear at 45 degrees from pole.
Previous registry studies of ceramic-on-polyethylene (C-PE) and ceramic-on-ceramic (COC) have focused on revision outcomes following primary surgery. Less is known about the effect of ceramic bearings on infection, dislocation, and mortality as outcomes following primary total hip arthroplasty (THA) for the Medicare population. We asked (1) does the use of C-PE bearings influence outcomes following THA as compared with metal-on-polyethylene (M-PE); and (2) does the use of COC bearings influence outcomes following THA as compared with M-PE? A total of 315,784 elderly Medicare patients (65+) who underwent primary THA between 2005 and 2014 with known bearing types were identified from the Medicare 100% inpatient sample administrative database. Outcomes of interest included relative risk of 90-day readmission, infection, dislocation, revision, or mortality at any time point after primary surgery. Propensity scores were developed to adjust for selection bias in the choice of bearing type at index primary surgery. Cox regression incorporating propensity score stratification (10 levels) was then used to evaluate the impact of bearing surface selection on outcomes, after adjusting for patient-, hospital-, and surgeon-related factors.Introduction
Methods
Previous studies of ceramic-on-polyethylene (C-PE) and ceramic-on-ceramic (COC) hip bearings have focused on outcomes following primary surgery. Less is known about the utilization or outcomes of ceramic bearings in revision total hip arthroplasty (R-THA) for the Medicare population in the US. We asked (1) what is the utilization of ceramic bearings for R-THA in the Medicare population and how has it evolved over time; (2) does the use of C-PE bearings influence outcomes following R-THA as compared with metal-on-polyethylene (M-PE); and (3) does the use of COC bearings influence outcomes following R-THA as compared with M-PE? A total of 31,809 Medicare patients (aged > 65y) who underwent R-THA between 2005 and 2013 with known bearing types were identified from the Medicare 100% inpatient sample administrative database. Outcomes of interest included relative risk of readmission (90 days) or infection, dislocation, rerevision, or mortality at any time point after revision. Propensity scores were developed to adjust for selection bias in the choice of bearing type at revision surgery. Cox regression incorporating propensity score stratification (10 levels) was then used to evaluate the impact of bearing surface selection on outcomes, after adjusting for patient-, hospital-, and surgeon-related factors.Introduction
Methods
In total joint replacement devices, material loss from the taper junctions is a clinical concern. Previous studies of explanted orthopedic devices have relied on visual scoring methods to quantify the fretting-corrosion damage on the component interfaces. Previous research has shown that visual fretting-corrosion evaluation is correlated to the volume of material loss [1], but scoring is semi-qualitative and does not provide a quantitative measure of the amount of material removed from the surface. The purpose of this study was to develop and validate a quantitative method for measuring the volume of material lost from the surfaces of explanted devices at the taper-trunnion junction. 10 new exemplar taper adapter sleeves (Ceramtec, Plochingen, Germany) were used for method validation. By using exemplar devices we were able to create clinically realistic taper damage in a controlled and repeatable manner using machining tools. Taper surfaces were measured before and after in vitro material removal using a roundness machine (Talyrond 585, Taylor Hobson, UK). Axial traces were measured on each taper surface using a diamond stylus. The mass of artificially removed material was also measured gravimetrically using a microgram balance (Sartorius, CPA225D, accuracy = ± 0.00003g). Surface profiles were analyzed using a custom MatLab script and Talymap software was used to provide 3D visualizations of the pattern of material loss. Calculated volumetric material loss was compared to the gravimetric value. A sensitivity analysis was conducted to determine the optimum number of traces to characterize the material loss from taper junctions.Introduction
Methods
First-generation annealed HXLPE has been clinically successful at reducing both clinical wear rates and the incidence of osteolysis in total hip arthroplasty. However, studies have observed oxidative and mechanical degradation occurring in annealed HXLPE. Thus, it is unclear whether the favorable clinical performance of 1st generation HXLPE is due to the preservation of bearing surface tribological properties or, at least partially, to the reduction in patient activity. The purpose of this study was to evaluate the in vitro wear performance (assessed using multidirectional pin-on-disk (POD) testing) of 1st-generation annealed HXLPE with respect to in vivo duration, clinical wear rates, oxidation, and mechanical properties. 103 1st-generation annealed HXLPE liners were collected at revision surgery. 39 annealed HXLPE liners were selected based on their implantation time and assigned to three equally sized cohorts (n=13 per group); short-term (1.4–2.7y), intermediate term (5.2–8.0y) and long-term (8.3–12.5y). From each retrieved liner, two 9-mm cores were obtained (one from the superior region and one from the inferior region). Sixteen cores were fabricated from unimplanted HXLPE liners that were removed from their packaging and six pins from unirradiated GUR 1050 resin served as positive controls. Multidirectional POD wear testing was conducted against wrought CoCr disks in a physiologically relevant lubricant (20 g/L protein concentration) using a 100-station SuperPOD (Phoenix Tribology, UK). Each pin had its own chamber with 15mL lubricant maintained at 37±1°C. An elliptical wear pattern with a static contact stress of 2.0 MPa was employed. Testing was carried out to 1.75 million cycles at 1.0 Hz and wear was assessed gravimetrically. POD wear rates were calculated using a linear regression of volumetric losses. In vivo penetration was measured directly using a calibrated micrometer. Oxidation was assessed on thin films obtained from superior and inferior regions of the liners (ASTM 2102). Mechanical properties were assessed using the small punch test (ASTM 2183).Introduction
Materials and Methods