Third-body abrasive wear challenge of 32 mm conventional and 44 mm highly crosslinked polyethylene liners in a hip simulator model.

Hip simulator studies have shown that wear in the polyethylene liners used for total hip replacements increased with the larger-diameter femoral balls and could also be exacerbated by third-body abrasion. However, they also indicated that the more highly cross-linked polyethylene (HXPE) bearings were more wear resistant than conventional polyethylene (CXPE) bearings. Unfortunately the HXPE bearings appeared to be particularly sensitive to adverse wear conditions. One simulator study in particular indicated that poly(methyl methacrylate) (PMMA) debris increased wear sixfold by means of two-body abrasive interactions rather than the supposed third-body abrasion or roughening effects of the Co-Cr surfaces. There has been no confirmation of such novel theories. Therefore the goal of this study was to investigate the sensitivity of large-diameter HXPE bearings to the third-body PMMA wear challenge in a hip simulator model. An orbital hip simulator was used in standard test mode with a physiological load profile. The 32 mm control liners were machined from moulded GUR1050 and gamma irradiated to 35 kGy under nitrogen (CXPE). The 44 mm liners were also from moulded blanks, gamma irradiated to 75 kGy, machined to shape, given a proprietary heat treatment, and sterilized by gas plasma (HXPE). As in the published simulator model, the study was conducted in three phases. In phase 1, all cups were run in standard ('clean') lubricant for 1.5 x 10(6) cycles duration. In phase 2, three CXPE cups and six HXPE cups were run for 2 x 10(6) cycles with a slurry of PMMA particles added to the lubricant. In phase 3, the implants were again run in 'clean' lubricant for 2 x 10(6) cycles duration. In addition, three HXPE cups were run as wear controls for 5.5 x 10(6) cycles duration in clean lubricant. In phase-1, the HXPE liners demonstrated twelvefold reduced wear compared with the CXPE controls. The 32 mm and 44 mm Co-Cr balls were judged of comparable roughnesses. However, the surface finish of HXPE liners was superior to that of CXPE liners. In phase-2 abrasion, wear rates increased sixfold and eighty-fold for CXPE and HXPE bearings respectively. These data confirmed that HXPE bearings were particularly sensitive to 'severe' test modes. The Co-Cr balls revealed numerous surface patches representing transferred PMMA with average transient roughness increased to 25 nm and 212 nm for the 32 mm and 44 mm balls respectively. These PMMA patches produced an aggressive two-body abrasion wear of the polyethylene. After cleaning, the ball roughness returned to near normal. Therefore the Co-Cr roughness was not an issue in this severe test mode. In phase 3, the wear decreased to near the index values of phase 1, while liner roughness dropped by more than 90 per cent. The control CXPE liners now demonstrated twice the wear of the HXPE, as would be predicted comparing the diameter and cross-linking algorithms. No previous study has correlated polyethylene roughness profiles to wear performance. In phase 2, PMMA abrasion created significant damage to the polyethylene surfaces. The average roughness Sa of CXPE liners increased to 3.6 microm, a twenty-four-fold increase with some scratches up to 40 microm deep. The HXPE roughness also increased but only to 1.5 microm, a ninefold increase. The scratch indices Sz and Sp for HXPE surfaces were also 50 per cent less severe than on CXPE surfaces. However, within 2 x 10(6) cycles duration of phase 3, all liners had recovered to virtually their original surface finish in phase 1. In all test phases, the surface finish of the HXPE liners remained superior to control liners. These experimental data confirmed many of the results from the previous simulator study with the PMMA abrasion models. Thus the 44 mm liners appeared an excellent clinical alternative to the smaller ball designs used in total hip replacements.

Pseudotumor and Subsequent Implant Loosening as a Complication of Revision Total Hip Arthroplasty with Ceramic-on-Metal Bearing: A Case Report.

Pseudotumors are not uncommon complications after total hip arthroplasty (THA) and may occur due to differences in bearing surfaces of the head and the liner ranging from soft to hard articulation. The most common causes of pseudotumors are foreign-body reaction, hypersensitivity and wear debris. The spectrum of pseudotumor presentation following THA varies greatly-from completely asymptomatic to clear implant failure. We report a case of pseudo-tumor formation with acetabular cup aseptic loosening after revision ceramic-on-metal hip arthroplasty. The patient described herein underwent pseudotumor excision and re-revision complex arthroplasty using a trabecular metal shell and buttress with ceramic-on-polyethylene THA. Surgeons should be aware of the possibility of a pseudotumor when dealing with revisions to help prevent rapid progression of cup loosening and implant failure, and should intervene early to avoid complex arthroplasty procedures.

Chemically driven tetragonal-to-monoclinic polymorphic transformation in retrieved ZTA femoral heads from dual mobility hip implants.

Two short-term (two and nine months) retrieved zirconia-toughened alumina (ZTA) femoral heads and nine pristine femoral heads from the same manufacturer have been investigated with respect to their surface stability by means of confocal Raman spectroscopy. Quantitative estimations of monoclinic volume fraction have been carried out in both non-wear and main wear zones of the retrieved heads, which invariantly showed high volume fractions of monoclinic polymorph. In-depth (sub-surface) profiles, non-destructively collected in the main wear zones with the Raman probe in confocal configuration, indeed confirmed that polymorphic transformation was extended down to 100µm below the bearing surface of the femoral heads. Acceleration of tetragonal-to-monoclinic transformation rate leads to unexpectedly high fractions of monoclinic phase within very short-term in-vivo exposures. Phase transformation in-vivo is much more marked than what one could actually predict according to simply simulating a hydrothermal environment in-vitro and could not be simply ascribed to the mechanical stress fields generated during normal service at the bearing surface. Instead, the chemical consequences of metal contamination on the ZTA femoral head surface are shown to play the most detrimental role in phase destabilization.

Discerning alumina ball wear from confounding metal transfer artifact.

On dismounting a ceramic femoral ball from its metal trunnion, there is usually a range of gray metallic bands transferred to the trunnion bore inside the ball. This creates an artifact that may compromise detection by weight of the exceedingly low wear rates of ceramic balls. The objective of this study was to compare the weight trending of the metal trunnions and their ceramic balls during conditioning studies. Our hypothesis was that a pretest conditioning protocol would eliminate or greatly reduce the metal transfer artifact. The balls and tapers were placed on a hip simulator under 300-600 load cycles but with no articulation. The balls were then dismounted from the trunnions, and both were cleaned and weighed. This was repeated 6-23 times. We developed a novel hydraulic method for dismounting balls from trunnions that proved to be safe and efficient. There was significant weight loss in the trunnions after the ball removal, but there was no corresponding weight gain in the alumina balls. The weight effect of the metal transfer appeared to have been removed from the balls with our standard cleaning procedures. Therefore, wear rates for alumina balls may be gravimetrically determined without compensating for the metal transfer from trunnion to ball.

Precision and accuracy in ceramic-on-ceramic wear analyses: influence of simulator test duration.

In this, the first report of precision and accuracy in simulator studies, ceramic-ceramic implants with ultra-low wear trends represented a relevant wear model. The effect of test durations was examined in a standard simulator test mode on the quality of the linear regression trends, the average wear estimates, and the amount of noise in the data. Three sets of diametral tolerances were compared in 28 mm diameter alumina implants. The authors' hypothesis was that wear data would be significantly improved with increased test durations. The average wear rates varied little with test duration, the biggest change amounting to only 30 and 15 per cent decreases in the wear estimate by 10 and 14 million cycles respectively. The most satisfactory improvement in the study was the decrease in variance (noise) with increasing duration, +/- 200 per cent at 5 million cycles reduced to +/- 55 per cent at 14 million cycles. The quality of the linear regression coefficients improved 150 per cent by 10 million cycles and 250 per cent by 14 million cycles. Overall the ceramic implants with highest diametral tolerances showed the least wear (15 per cent less, but not statistically significant). However, given such low wear rates for alumina liners, it was unlikely that any differences owing to diametral tolerances would be clinically significant in the typical patient.

Fluid-sorption phenomena in sterilized polyethylene acetabular prostheses.

The weight changes due to fluid-sorption were measured in 62 radiation-sterilized acetabular sockets and 10 unsterilized discs. The materials included two types of ultra-high molecular weight (UHMW) polyethylene (RCH 1000; Hi-Fax 1900) and a carbon-fibre-reinforced polyethylene (CFPE). The fluid absorption curve was consistently biphasic. In the first 30 d soak-period (Phase 1), the initial rate of fluid absorption averaged 153 micrograms/d for conventional UHMW polyethylene and 278 micrograms/d for carbon-fibre-reinforced polyethylene. In Phase 2, beyond 30 d and up to 400 d, fluid absorption reduced to linear rates of 27 micrograms/d for UHMW polyethylene and 43 micrograms/d for CFPE. The latter soak-weight-gain values corresponded to only 0.00016%/d and 0.00034%/d respectively. There was little difference in absorption rates between sterilized and unsterilized samples. However soak rates were generally higher in water compared to serum.

Wear-screening and joint simulation studies vs. materials selection and prosthesis design.

Satisfactory friction and wear performance of orthomedic biomaterials is an essential criterion for both hemiarthroplasty and total joint replacements. This report will chart the clinical historical experience of candidate biomaterials with their wear resistance and compare/contrast these data to experimental test predictions. The latter review will encompass publications dealing with both joint simulators and the more basic friction and wear screening devices. Special consideration will be given to the adequacy of the test protocol, the design of the experimental machines, and the accuracy of the measurement techniques. The discussion will then center on clinical reality vs. experimental adequacy and summarize current developments.

Clinical and simulator wear study of alumina ceramic THR to 17 years and beyond.

Three THAs with cementless monolithic alumina ceramic sockets and cementless Co-alloy stems were retrieved because of aseptic loosening after 17 and 24 years. At revision heads and cups were marked for orientation. Maps were drawn of wear patterns with the use of light microscopy and surveyed by SEM. In a simulator experiment 28-mm-diameter alumina heads and liners were used. The cups were mounted inverted in a hip simulator and run with calf serum as the lubricant. The hip loads were 2 kN maximum and a 1-Hz frequency for 20 million cycles. Wear severity was classified into five grades. In retrieved implants, SEM analysis showed that the main wear zones (MWZ) had Grade 4 wear. The peripheral wear zones (PWZ) showed grain pull-out regions (Grade 5 wear). These corresponded to neck-socket impingement and head-acetabular cup separation. Gray was due to transferred CoCr particles from the stem. In the simulator study, the MWZ had only localized areas of grain pull out surrounded by polished surface regions (Grade 4 wear) at 20 million cycles; stripe wear was not seen. The alumina ceramic bearings proved excellent up to 22 years in simulator studies and clinical studies. However, microseparation kinematics would be necessary in the simulator to duplicate the more peripheral wear zones.

Symposium on Surface Replacement Arthroplasty of the Hip. Biomechanics: mutifactorial design choices--an essential compromise?

The main flaws to be overcome in realizing the potential success of the double-cup arthroplasty procedure are failures due to femoral cup loosening, acetabular cup loosening, and femoral-neck fractures. The clinical uncertainties include the selection of a suitable patient with adequate bone stock and the technical difficulties associated with (I) reaming the acetabulum adequately, (2) reaming down onto the neck without violating it, and (3) anchoring the components securely by interdigitation of acrylic cement. The higher frictional torques of the double-cup arthroplasty designs are not a clinical loosening issue--the resulting acetabular cement-bone shear stresses are very low. Computer models of both the femoral and acetabular components predict significant stress shielding of the cancellous bone under metal femoral shells. At the rim of the femoral cup, the stresses are increased by a factor of 3 owing to the stress concentration effect and can rise to a factor of 10 if cystic or osteoporotic changes are present. This finding if confirmed in the three-dimensional models may explain some of the femoral neck fractures. The thin polyethylene acetabular cups may also cause a stress concentration effect on the underlying cement and bone. This may explain the higher incidence of radiographic loosening around the acetabulum in double-cup arthroplasty designs compared with total hip replacements. Metal-backed sockets may reduce cancellous bone stresses and appear advantageous. There is no clinical evidence of unusual wear or wear-related problems. However, new material formulations are now either in use or being planned for the double-cup arthroplasty designs. As yet, there have been no published data on hip simulator wear for the efficacy of any of the current or proposed changes. Biologic fixation appears to be the theme for the 1980s. However, the combination of technology, design instrumentation, and patient selection will be critical in achieving success with this technically difficult procedure.

Charnley wear model for validation of hip simulators--ball diameter versus polytetrafluoroethylene and polyethylene wear.

Wear rates of polytetrafluoroethylene (PTFE) and polyethylene cups were compared in 9-channel and 12-channel simulators, using serum lubrication and gravimetric techniques for wear assessment. Cobalt-chromium (CoCr) and alumina ceramic femoral heads in 22-42 mm diameter range were used to validate simulator wear rates against clinical data. This was also the first study of three femoral head sizes evaluated concurrently in a simulator (with three replicate specimens) and also the first report in which any wear experiments were repeated. Fluid absorption artefacts were within +/-1 per cent of wear magnitude for PTFE and +/-8 per cent for polyethylene and were corrected for. Wear rates were linear as a function of test duration. Precision within each set of three cups was within +/-6 per cent. The wear rates from experiments repeated over 15 months were reproducible to within +/-24 per cent. However, the magnitudes of the simulator wear rates were not clinically accurate, the PTFE wear rates (2843 mm3/10(6) cycles; 22 mm diameter) were over three times higher than in vivo, the polyethylene 30 to 50 per cent on the low side (23 mm3/10(6) cycles; 22 mm diameter). Volumetric wear rate increased with respect to size of femoral head and a linearly increasing relationship of 7 8 per cent/mm was evident with respect to femoral head diameter for both PTFE and polyethylene. These data compared well with the clinical data.

Ultra-low wear rates for rigid-on-rigid bearings in total hip replacements.

With the increased clinical interest in metal-on-metal and ceramic-on-ceramic total-hip replacements (THRs), the objective of this hip simulator study was to identify the relative wear ranking of three bearing systems, namely CoCr-polyethylene (M-PE), CoCr-CoCr (M-M) and ceramic-on-ceramic (C-C). Volumetric wear rates were used as the method of comparison. The seven THR groupings included one M-PE study, two M-M studies and four C-C studies. Special emphasis was given to defining the 'run-in' phase of accelerated wear that rigid-on-rigid bearings generally exhibit. The hypothesis was that characterization of the run-in and steady state wear phases would clarify not only the tribological performance in vitro but also help correlate these in vitro wear rates with the 'average' wear rates measured on retrieved implants. The implant systems were studied on multichannel hip simulators using the Paul gait cycle and bovine serum as the lubricant. With 28 mm CoCr heads, the PE (2.5 Mrad/N2) wear rates averaged 13 mm3/10(6) cycles duration. This was considered a low value compared with the clinical model of 74 mm3/year (for 28 mm heads). Our later studies established that this low laboratory value was a consequence of the serum parameters then in use. The mating CoCr heads (with PE cups) wore at the steady state rate of 0.028 mm3/10(6) cycles. The concurrently run Metasul M-M THRs wore at the steady state rate of 0.119 mm3/10(6) cycles with high-protein serum. In the second Metasul M-M study with low-protein serum, the THR run-in rate was 2.681 mm3/10(6) cycles and steady state was 0.977 mm3/10(6) cycles. At 10 years, these data would predict a 70-fold reduction in M-M wear debris compared with the clinical PE wear model. All M-M implants exhibited biphasic wear trends, with the transition point at 0.5 x 10(6) cycles between run-in and steady state phases, the latter averaging a 3-fold decrease in wear rate. White surface coatings on implants (coming from the serum solution) were a confounding factor but did not obscure the two orders of magnitude wear performance improvement for CoCr over PE cups. The liners in the alumina head-alumina cup combination wore at the steady state rate of 0.004 mm3/10(6) cycles over 14 x 10(6) cycles duration (high-protein serum). The zirconia head-alumina cup THR combination wore at 0.174 and 0.014 mm3/10(6) cycles for run-in and steady state rates respectively (low-protein serum). The zirconia head and cup THR combination wore slightly higher initially with 0.342 and 0.013 mm3/10(6) cycles for run-in and steady state rates respectively. Other wear studies have generally predicted catastrophic wear for such zirconia-ceramic combinations. It was noted that the zirconia wear trends were frequently masked by the effects of tenacious white surface coatings. It was possible that these coatings protected the zirconia surfaces somewhat in this simulator study. The experimental ceramic Crystaloy THR had the highest ceramic run-in wear at 0.681 mm3/10(6) cycles and typical 0.016 mm3/10(6) cycles for steady state. Since these implants represented the first Crystaloy THR sets made, it was likely that the surface conditions of this high-strength ceramic could be improved in the future. Overall, the ceramic THRs demonstrated three orders of magnitude wear performance improvement over PE cups. With zirconia implants, while the cup wear was sometimes measurable, head wear was seldom discernible. Therefore, we have to be cautious in interpreting such zirconia wear data. Identifying the run-in and steady state wear rates was a valuable step in processing the ceramic wear data and assessing its reliability. Thus, the M-M and C-C THRs have demonstrated two to three orders of reduction in volumetric wear in the laboratory compared with the PE wear standard, which helps to explain the excellent wear performance and minimal osteolysis seen with such implants at retrieval operations.

Legal liability and orthopedic surgery.

The Legal and Engineering Interfaces of Orthopedic Surgery.

A simulator study of adverse wear with metal and cement debris contamination in metal-on-metal hip bearings.

OBJECTIVES: Third-body wear is believed to be one trigger for adverse results with metal-on-metal (MOM) bearings. Impingement and subluxation may release metal particles from MOM replacements. We therefore challenged MOM bearings with relevant debris types of cobalt-chrome alloy (CoCr), titanium alloy (Ti6Al4V) and polymethylmethacrylate bone cement (PMMA). METHODS: Cement flakes (PMMA), CoCr and Ti6Al4V particles (size range 5 µm to 400 µm) were run in a MOM wear simulation. Debris allotments (5 mg) were inserted at ten intervals during the five million cycle (5 Mc) test. RESULTS: In a clean test phase (0 Mc to 0.8 Mc), lubricants retained their yellow colour. Addition of metal particles at 0.8 Mc turned lubricants black within the first hour of the test and remained so for the duration, while PMMA particles did not change the colour of the lubricant. Rates of wear with PMMA, CoCr and Ti6Al4V debris averaged 0.3 mm(3)/Mc, 4.1 mm(3)/Mc and 6.4 mm(3)/Mc, respectively. CONCLUSIONS: Metal particles turned simulator lubricants black with rates of wear of MOM bearings an order of magnitude higher than with control PMMA particles. This appeared to model the findings of black, periarticular joint tissues and high CoCr wear in failed MOM replacements. The amount of wear debris produced during a 500 000-cycle interval of gait was 30 to 50 times greater than the weight of triggering particle allotment, indicating that MOM bearings were extremely sensitive to third-body wear. Cite this article: Bone Joint Res 2015;4:29-37.

What is a "normal" wear pattern for metal-on-metal hip bearings?

In addition to classical run-in and steady-state wear phases, metal-on-metal (MOM) hip bearings have encountered "runaway wear" (RAW) trends in simulator studies. This puzzling behavior has resulted in 2- to 19-fold wear increases compared with other apparently "identical" bearings. MOM bearings have shown five identifiable RAW wear patterns in joint simulators; therefore, additional descriptive terms were used here to indicate various observed patterns, for example, "breakaway wear" (BAW), which was defined as a higher wear trend that recovers to steady-state wear. As these trends commonly occur for MOM, this raises the question of what can be considered "normal" behavior or "abnormal"? In an effort to identify possible causes for this behavior, the current study investigated six Co-Cr bearings, which closely matched with respect to geometrical tolerances. Despite close control of design and test variables, BAW occurred in 30% of the MOM bearings, producing a threefold wear increase above otherwise identical MOM bearings within the same group. The majority of the BAW (85%) occurred on the cup side and was validated by growth of wear scars and concentrations of metal ions. One bearing that showed continuing BAW at 5 Mc revealed a cup that was 50% smoother than other cups whereas its mating head was 50% rougher, thus signifying that highly polished areas were sites of the highest MOM wear. The two BAW bearings with high wear showed the greatest conformity at 5 Mc, in apparent contradistinction to classical lubrication theory.

"Severe" wear challenge to 36 mm mechanically enhanced highly crosslinked polyethylene hip liners.

Our purpose was to compare the wear performance of mechanically enhanced 5Mrad highly crosslinked polyethylene (MEP, ArComXL) hip liners to (control) 3Mrad UHMWPE liners (ArCom) in 36 mm head size. As a more severe synergy of clinically relevant test models, we contrasted wear with custom roughened Co-Cr surfaces (Ra 500 nm) to the standard pristine Co-Cr heads (Ra < 20 nm) using a severe microseparation test mode in our hip simulator. We adopted a previously published model to estimate potential biological activity. On new Co-Cr heads, the MEP liners showed a 47% reduction in volumetric wear a 13% reduction in wear particle size and a 27% reduction in Functional Biological Activity (FBA) compared to our control. On rough Co-Cr heads, the MEP liners showed little advantage in terms of volumetric wear compared with the control. However, the MEP liners overall showed a 38% reduction in FBA compared to the control owing to a larger volume fraction of larger particles. Thus overall the MEP liners appeared to offer advantages in terms of reduced FBA indices.

Role of ceramic implants. Design and clinical success with total hip prosthetic ceramic-to-ceramic bearings.

Ceramic implants have become of great interest because of the increased awareness that wear debris from metal-polyethylene components of total hip prostheses can cause osteolysis around implants. Polyethylene wear rates with the Charnley total hip prosthesis were found to be from 0.1 to 0.2 mm/year in the elderly, which corresponded to 30 to 80 mm3 of polyethylene debris being released to the joint tissues. This in turn can be related to 40 million to 40 billion particles being released into the joint every year. This polyethylene particulate is heavily implicated in the osteolytic destruction of periarticular tissues. The ceramic ball, ceramic cup combination of total hip prostheses may have promise of wear rates that could be thousands of times smaller than polyethylene alone. Such alumina ceramic prosthetic concepts were introduced in Europe from 1970 to 1973. Under Food and Drug Administration regulations at that time, the only U.S. introductions allowed circa 1980 were the Autophor and Xenophor types of ceramic prostheses. However, this particular prosthetic design was not successful in the United States because of pain, neck-socket impingement, ceramic fracture, and component loosening. This did not therefore appear to be a successful compromise in the hands of U.S. surgeons. Ceramic innovations from Europe now include cemented ceramic cups of "matching" tolerances with the femoral ball, and press-fit Ti-alloy acetabular shells with modular ceramic inserts. In addition, alumina and zirconia ceramic balls are now in routine clinical use in Europe. The objectives of this Symposium are to highlight these ceramic ball, ceramic cup innovations with their long-term clinical results from Europe. Then one can evaluate which of these innovations in material and design selections offers the best possible alternatives in the 1990s.