Mid-term results of ReCap/Magnum/Taperloc metal-on-metal total hip arthroplasty with mean follow-up of 7.1 years.

INTRODUCTION: Despite enthusiasm for metal-on-metal bearings, disappointing short- to mid-term outcomes has all but halted the use of this bearing articulation. This review presents mid-term results for the ReCap Magnum total hip replacement. PATIENTS AND METHODS: This prospective study evaluated 79 ReCap/Magnum/Taperloc total hip replacements with mean follow-up of 7.1 (range 3.7-9.2) years. 43 were female and 36 male. Metal ions were measured and radiographic measurement included a 'margin of safety' angle to quantify risk of edge loading. When a clinical suspicion of adverse reaction to metal debris was present, patients had metal artefact reduction sequence MRI. Harris Hip Score and Oxford Hip Score evaluated functional outcome and SF-12 and EQ-5L-5D assessed quality of life at final follow-up. RESULTS: 7 hips were revised indicating 91.1% survivorship at 7.1 years. Postoperative Harris Hip Score and Oxford Hip Score significantly improved. Females and symptomatic patients predicted increased metal ions. Margin of safety correlated with postoperative Oxford Hip Score. Symptomatic hips and positive MRI showed reduced survivorship. CONCLUSIONS: Compared to more traditional bearings like metal or ceramic on polyethylene the overall outcome of this ReCap/Magnum/Taperloc study cohort is modest. It is felt that further failures will occur in this group therefore cautious interpretation of the results is justified given the potential for reduced survival outcomes.

Profiling the third-body wear damage produced in CoCr surfaces by bone cement, CoCr, and Ti6Al4V debris: a 10-cycle metal-on-metal simulator test.

Particles of bone cement (polymethyl methacrylate), CoCr and Ti6Al4V were compared for their abrasion potential against CoCr substrates. This appears to be the first study utilizing CoCr and Ti6Al4V particulates to abrade CoCr bearings and the first study profiling the morphology of third-body abrasive wear scratches in a hip simulator. The 5 mg debris allotments (median size range 140-300 µm) were added to cups mounted both inverted and anatomically with metal-on-metal (MOM) bearings in a 10-cycle, hip simulator test. Surface abrasion was characterized by roughness indices and scratch profiles. Compared to third-body abrasion with metal debris, polymethyl methacrylate debris had minimal effect on the CoCr surfaces. In all, 10 cycles of abrasion with metal debris demonstrated that roughness indices (Ra, PV) increased approximately 20-fold from the unworn condition. The scratch profiles ranged 20-108 µm wide and 0.5-2.8 µm deep. The scratch aspect ratio (W/PV) averaged 0.03, and this very low ratio indicated that the 140 µm CoCr beads had plastically deformed to create wide but shallow scratches. There was no evidence of transfer of CoCr beads to CoCr bearings. The Ti64 particles produced similar scratch morphology with the same aspect ratio as the CoCr particulates. However, the titanium particulates also showed a unique ability to flatten and adhere to the CoCr, forming smears and islands of contaminating metal on the CoCr bearings. The morphology of scratches and metal transfer produced by these large metal particulates in the simulator appeared identical to those reported on retrieved metal-on-metal bearings.

Risk of impingement and third-body abrasion with 28-mm metal-on-metal bearings.

BACKGROUND: Concerns have been raised about the sequelae of metal-on-metal (MoM) bearings in total hip arthroplasty (THA). However, retrieval studies, which offer the best insight into the clinically relevant mechanisms of MoM wear, have followed predictable trends to date such as indicting cobalt-chromium (CoCr) metallurgy, cup design, high conformity between the head and cup, "steep cups," "microseparation," and "edge wear." QUESTIONS/PURPOSES: We wished to evaluate a set of retrieved 28-mm MoM THA for signs of (1) cup-to-stem impingement; (2) normal wear pattern and concomitant stripe damage on femoral heads that would signify adverse wear mechanics; and (3) well-defined evidence of third-body scratches on bearings that would indicate large abrasive particles had circulated the joint space. METHODS: Ten 28-mm MOM retrievals were selected on the basis that femoral stems were included. Revision surgeries at 3 to 8 years were for pain, osteolysis, and cup loosening. CoCr stems and the MoM bearings were produced by one vendor and Ti6Al4V stems by a second vendor. All but two cases had been fixed with bone cement. We looked for patterns of normal wear and impingement signs on femoral necks and cup rims. We looked for adverse wear defined as stripe damage that was visually apparent on each bearing. Wear patterns were examined microscopically to determine the nature of abrasions and signs of metal transfer. Graphical models recreated femoral neck and cup designs to precisely correlate impingement sites on femoral necks to cup positions and head stripe patterns. RESULTS: The evidence revealed that all CoCr cup liners had impinged on either anterior or posterior facets of femoral necks. Liner impingement at the most proximal neck notch occurred with the head well located and impingement at the distal notch occurred with the head rotated 5 mm out of the cup. The hip gained 20° motion by such a subluxation maneuver with this THA design. All heads had stripe wear, the basal and polar stripes coinciding with cup impingement sites. Analysis of stripe damage revealed 40 to 100-µm wide scratches created by large particles ploughing across bearing surfaces. The association of stripe wear with evidence of neck notching implicated impingement as the root cause, the outcome being the aggressive third-body wear. CONCLUSIONS: We found consistent evidence of impingement, abnormal stripe damage, and evidence of third-body abrasive wear in a small sample of one type of 28-mm MoM design. Impingement models demonstrated that 28-mm heads could lever 20° out of the liners. Although other studies continue to show good success with 28-mm MoM bearings, their use has been discontinued at La Pitie Hospital.

Validation of a 3D CT method for measurement of linear wear of acetabular cups.

BACKGROUND: We evaluated the accuracy and repeatability of a 3D method for polyethylene acetabular cup wear measurements using computed tomography (CT). We propose that the method be used for clinical in vivo assessment of wear in acetabular cups. MATERIAL AND METHODS: Ultra-high molecular weight polyethylene cups with a titanium mesh molded on the outside were subjected to wear using a hip simulator. Before and after wear, they were (1) imaged with a CT scanner using a phantom model device, (2) measured using a coordinate measurement machine (CMM), and (3) weighed. CMM was used as the reference method for measurement of femoral head penetration into the cup and for comparison with CT, and gravimetric measurements were used as a reference for both CT and CMM. Femoral head penetration and wear vector angle were studied. The head diameters were also measured with both CMM and CT. The repeatability of the method proposed was evaluated with two repeated measurements using different positions of the phantom in the CT scanner. RESULTS: The accuracy of the 3D CT method for evaluation of linear wear was 0.51 mm and the repeatability was 0.39 mm. Repeatability for wear vector angle was 17°. INTERPRETATION: This study of metal-meshed hip-simulated acetabular cups shows that CT has the capacity for reliable measurement of linear wear of acetabular cups at a clinically relevant level of accuracy.

Characterization of protein degradation in serum-based lubricants during simulation wear testing of metal-on-metal hip prostheses.

A size exclusion high performance liquid chromatography (SEC-HPLC) method has been developed which is capable of separation and quantitation of bovine serum albumin (BSA) and bovine serum globulin (BSG) components of serum-based lubricant (SBL) solutions. This allowed characterization of the stability profiles of these proteins when acting as lubricants during hip wear simulation, and identification of wear-specific mechanisms of degradation. Using cobalt-chromium metal-on-metal (MOM) hip joints, it was observed that BSA remained stable for up to 3 days (215K cycles) of wear testing after which the protein degraded in a fairly linear fashion. BSG on the other hand, began to degrade immediately and in a linear fashion with a rate constant of 5% per day. Loss of both proteins occurred via the formation of high molecular weight aggregates which precipitated out of solution. No fragmentation of the polypeptide backbone of either protein was observed. Data obtained suggest that protein degradation was not due to microbial contamination, denaturation at the air-water interface, or frictional heating of articulating joint surfaces in these studies. We conclude that the primary source of protein degradation during MOM simulation testing occurs via high shear rates experienced by SBL solutions at articulating surfaces, possibly coupled with metal-protein interactions occurring as new and reactive metal surfaces are generated during wear testing. The development of this analytical methodology will allow new studies to clarify the role of SBL solutions in wear simulation studies and the interactions and lubricating properties of serum proteins with prosthetic surfaces other than MOM.

Polyethylene wear debris produced in a knee simulator model: effect of crosslinking and counterface material.

Polyethylene (PE) debris has been well studied in clinical retrievals and laboratory wear simulations of total hip replacements. However, little is known about PE debris from total knee replacements. In this study, we investigated the effects of crosslinking PE bearings and alternate counterface material. Mildly (35 kGy) and highly (70 kGy) crosslinked PE were studied in combination with CoCr and zirconia femoral counterfaces. Wear debris was isolated and its morphology characterized. Except for changes in PE debris size with the zirconia bearings, there were no morphological changes greater than 10%. The average submicron volume fraction decreased from about 65% to 45% with both increased crosslinking and changing counterface material from CoCr to zirconia. The averaged number of generated particles decreased by approximately fourfold with increased crosslinking and threefold with changing counterface material from CoCr to zirconia. This showed that the degree of PE crosslinking and the choice of counterface material were important factors in the PE wear debris production in total knee simulator replacements.

Delta ceramic-on-alumina ceramic articulation in primary THA: prospective, randomized FDA-IDE study and retrieval analysis.

UNLABELLED: Wear and osteolysis continue to be major reasons for revision surgery in THA. Ceramic-on-ceramic bearings eliminate polyethylene wear debris. The newest generation of these bearings incorporate nanosized, yttria-stabilized tetragonal zirconia particles producing an alumina matrix composite. We asked whether this new material would perform as well as a conventional bearing in terms of functional hip scores, radiographic migration and osteolysis, complications and survival. As part of a US FDA investigational device exemption study (G000075), we conducted an initial prospective safety study of 21 alumina matrix composite femoral heads articulating on alumina liners followed by a prospective, randomized study with 44 more of these articulations and 45 zirconia femoral heads on polyethylene liners. The minimum followup for all patients was 26 months (mean, 73 months; range, 26-108 months). Harris hip scores and radiographic findings were similar in the two groups as was survivorship (trial 95% versus control 93%). There were three reoperations in the trial group and three in the control group. A fractured head retrieval showed a 33% monoclinic transformation with an increase in surface roughness from 3 to 5 nm at the main wear zone. While our numbers were insufficient to compare device-related complications, the trial device performed as well as the control device in terms of reoperation, and clinical and radiographic outcome. The alumina matrix composite femoral head on an alumina liner provided high survivorship. LEVEL OF EVIDENCE: Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Comparing ceramic-metal to metal-metal total hip replacements--a simulator study of metal wear and ion release in 32- and 38-mm bearings.

Our 32 and 38 mm alumina ceramic-on-metal (COM) bearings were run in a hip simulator study for comparison with 32 mm metal-on-metal (MOM) controls. The 32 mm MOM bearings demonstrated an overall wear rate of 1.58 mm(3)/million cycles (Mc) that was comparable to previous simulator studies. The peak run-in MOM wear-rates (10, 15.7 mm(3)/Mc) were higher than in previous simulator studies. There was a noticeable graying in color of serum lubricants with MOM wear rates of 2-3 mm(3)/Mc and with wear rates of 10-15 mm(3)/Mc the serum became much darker. The COM lubricants darkened during two "break-away" wear events with wear-rates 5.8-6.7 mm(3)/Mc. The 32 and 38 mm COM bearings demonstrated overall wear-rates of 0.38 and 0.29 mm(3)/Mc, approximately four-fold reduced compared to MOM controls. The COM wear-rates were also much higher than in the one previous COM study. There may be methodological reasons that could explain this discrepancy. Our ion concentrations assessed from serum lubricants had Cobalt (Co) 68% and Chromium (Cr) 32% for average ratio of metal ion composition (i.e. averaging Co/Cr ratios: 2.26) in the parent alloy. Comparing Co ion concentrations during run-in, the COM bearings represented a 35-fold reduction compared to MOM. At 3.0 Mc, the COM represented a 33-fold reduction compared to MOM. Overall, our simulator study confirmed previously published advantages of low wear and reduced metal ions with the ceramic-metal coupling compared to standard metal-metal bearings.

How do alternative bearing surfaces influence wear behavior?

Metal, ceramic, and polyethylene liners represent contemporary bearing choices for total joint replacement. Each has limitations in terms of design, sensitivity to manufacturing, and surgical placement. With polyethylene, larger femoral heads represent a design restriction and a potential wear issue. One side benefit is that polyethylene does not click, squeak, or create stripe wear. The attraction of hard-on-hard bearings (metal-on-metal, ceramic-on-ceramic) is that their typically ultra-low wear alleviates concerns with large femoral head designs. However, hard-on-hard bearings produce stripe wear due to the effects of the rigid liner edge. Slight subluxation (microseparation) during swing phase of gait can result in stripe wear on the ball and liner rim. In addition, high levels of implant wear with vertically placed cups can be anticipated. Currently, only alumina-on-alumina bearings can claim virtually no biologic risk. Thus, the role of laboratory studies is to isolate relevant aspects of performance by cup design and to predict the risk-benefit ratios in patients requiring total hip replacement.

Surface damage after multiple dislocations of a 38-mm-diameter, metal-on-metal hip prosthesis.

We present, for the first time, a detailed damage assessment of a large-diameter metal-on-metal (L-MOM) hip prosthesis to show the extent of surface damage that can occur in a patient after multiple dislocations. The patient was a man (51 years old) who dislocated 8 times and was finally revised at 27 months. Radiographically, the cup was malpositioned with 65 degrees lateral opening and 15 degrees retroversion. The retrieved cup was a 1-piece, 38-mm Co-Cr-Mo (M2a; Biomet, Warsaw, Ind) with a titanium-alloy backing. The retrieved components demonstrated all known modes of wear, including a polished wear scar, multidirectional scratching, "stripe" wear, surface contamination of titanium-alloy, front face wear, and backside wear. The clinical significance is that cup positioning remains critical regardless of whether a large diameter head is used or not.

Ceramic total hip arthroplasty in the United States: safety and risk issues revisited.

The advantages of all-alumina bearings are superb wear resistance, stability, and inertness demonstrated over 3 decades. The disadvantage is a small risk for brittle fracture, as described in this paper. Surveying the latest ceramic hip series reported in recent journal articles or presented at the 6th World Biomaterials Congress, we found 11 studies representing more than 35,000 cases followed for 3 to 25 years. There were 24 reported fractures. A unique survey of hip complications in the 1990s found a fracture risk of approximately 1.4 per 1000 ceramic balls used in the United States. A company database holding more than 2.5 million records described the overall fracture risk as 1 per 10,000 cases. Initial use of ceramic cup inserts indicated a 2% to 3% incidence of chipping during surgery. Beginning in 1997, the number of ceramic-metal cup-locking cases entered into a US Food and Drug Administration ceramics database was more than 2400, with no fractures reported by the FDA in July 2003.

Y-TZP zirconia run against highly crosslinked UHMWPE tibial inserts: knee simulator wear and phase-transformation studies.

BACKGROUND: Zirconia (ZrO(2)) ceramics combined with highly cross-linked polyethylene appears to be a promising approach to minimize wear in artificial knee joints. The wear performance of yttria-stabilized zirconia (YZr) femoral condyles on 7-Mrad tibial inserts was compared in a knee simulator to CoCr bearing on 3.5-Mrad inserts. METHODS: The knee design was the Bi-Surface type with a 9-year clinical history in Japan (JMM, Japan). A displacement-controlled knee simulator was used with kinematics that included 20 degrees flexion, +/-5 degrees rotation, and 6 mm anterior/posterior translation. Lubricant was alpha-calf serum, test duration was 10 million cycles (10 Mc), and wear was measured by weight-loss techniques. The wear zones were studied by laser interferometry, scanning electron microscopy, and Raman microprobe spectroscopy. RESULTS: At 10 Mc the wear rates of the CoCr controls averaged 4.5 mm(3)/Mc. This was within 7% of the prior estimate at 5-Mc duration and comparable to Bi-Surface wear data from another laboratory. The CoCr condyles increased in roughness (R(a)) from <50 nm to average R(a) = 250 nm due to linear scratching. The ceramic condyles remained pristine throughout the wear study (R(a) <7 nm). With the YZr/7-Mrad combination, the weight change had a positive slope over at 10 Mc, which meant that the actual polyethylene wear was unmeasurable. Microscopic examinations at 10 Mc showed that the zirconia surfaces were intact and there was no detectable change from tetragonal to monoclinic phase. INTERPRETATION: Our laboratory knee wear simulation appeared very supportive of the 9-year YZr/PE clinical results with Bi-Surface total knee replacements in Japan.

Wear of sequentially enhanced 9-Mrad polyethylene in 10 million cycle knee simulation study.

Highly crosslinked polyethylene (HXPE) has been shown to be effective in reducing wear in total hip replacements. HXPE has not found widespread use in TKR, because the crosslinking inevitably leads to reductions in critical properties such as toughness and fatigue strength. Sequentially enhanced crosslinking (SXPE) have been suggested for improved wear resistance for tibial inserts with maintenance of mechanical properties and anticipated high oxidation resistance superior to conventional polyethylene (XLPE). We compared the wear of SXPE (9Mrad) to XLPE inserts (3Mrad) to 10 million cycles. Triathlon femoral condyles were identical in both. This is the first wear study of SXPE inserts. According to the power law relating irradiation dose to wear of XLPE inserts, wear of 9 Mrad inserts should be reduced by 70% compared to 3Mrad controls. The wear rates of the SXPE inserts were reduced by 86% at 10 million cycles duration, somewhat greater than predicted. The one prior investigation by the manufacturer reported a 79% wear reduction for SXPE compared to controls in a 5 million cycle simulator study in knee design and test parameters. There were important differences between the two studies. Nevertheless there clearly appeared to be a major benefit for sequentially enhanced polyethylene in tibial inserts. This combined wear reduction of 80-85% with improved oxidation resistance and retention of mechanical properties may prove beneficial for active patients who may otherwise risk high wear rates over many years of use.

Wear in molded tibial inserts: knee simulator study of H1900 and GUR1050 polyethylenes.

Hi-fax 1900 tibial inserts were used in the IB-1 total knee replacement (TKR) beginning 1978, soon followed by the AGC design. Such direct compression molded (DCM) inserts was relatively immune to oxidation. Unfortunately the Hi-fax 1900 resin (H1900) was taken off the market in year 2004. As an alternate, GUR1050 was introduced in the Vanguard TKR. However there appeared to be little or no wear comparisons of molded inserts. Therefore the study aim was to compare wear performance of GUR1050 to the historical H1900. The hypothesis was that Hi-fax and GUR1050 would show comparable wear performance. The Vanguar was a posterior-cruciate sacrificing design (Biomet Inc.). All tibial inserts were sterilized by gamma-radiation (3.2 Mrad) under argon. A 6-channel, displacement-controlled knee simulator was used with serum lubricant (protein concentration 20 mg/mL). Wear assessments were by gravimetric methods and linear regression techniques. The gross weight-loss trends over 2.5 Mc duration demonstrated excellent linear behavior with good agreement between TKR sets (<+/-10%). Fluid sorption artifacts in control represented less than 5% of gross wear magnitudes. Thus suitable corrections could be made in determining net wear. The H1900 and GUR1050inserts demonstrated net wear-rates of 3.6 and 3.4 mm(3)/Mc, respectively. This difference was not found to be statistically significant. This wear study demonstrated that GUR1050 inserts were indistinguishable from the Hi-fax 1900 in terms of laboratory wear performance, proving our hypothesis. Given the excellent clinical history of DCM Hi-fax 1900, the GUR1050 should be an ideal candidate for TKR.

Possible triggers for phase transformation in zirconia hip balls.

The clinical history of yttria-stabilized, zirconia (Zr) ceramic has been controversial. In the patient, combinations of hydrothermal and mechanical shocks may trigger detrimental changes in Zr balls that have inferior metastability. Transformations from tetragonal to monoclinic phase may be influenced by impingement, dislocation, and disassociation in certain patients. Hydrothermal stability was measured in Zr balls from four vendors by autoclave and mechanical models that included "cup-impingement," "abrasive" wear, and "3rd-body" wear. Standard simulator tests for polyethylene (PE) wear studies combined pristine and previously transformed Zr and were also used to test lubricant effects (Zr/Zr-serum, Zr/Zr-water, Zr/PE-water). For in-vivo comparisons we studied retrieved Zr balls at 1-15 years follow-up by laser interferometry, SEM, EDS, XRD, and Raman spectroscopy. We found that severe mechanical shock triggered local surface destruction but little transformation. In contrast, hydrothermal processes revealed 5-13% monoclinic by 7 h, increasing at a rate of 0.56%/h for 22-mm balls and 0.81%/h for 26-mm balls. The all-ceramic Zr/Zr bearings were very sensitive to lubrication mode, showing early catastrophic failure when run in water but surviving 20 million cycles when run with serum lubrication. Wear with Zr/PE combination did not trigger phase changes in water or serum but decreased the monoclinic content measured on previously transformed surfaces. Most retrieved Zr balls showed high transformation (30-85% monoclinic) but some showed no transformation. The ball areas with major monoclinic changes corresponded to PE contact, suggesting that tribological conditions under the cup were the trigger. This indicated that we understand little of the hydrothermal conditions operating under Zr/PE hip joints in-vivo.

Dose effects of cross-linking polyethylene for total knee arthroplasty on wear performance and mechanical properties.

Wear performance and mechanical properties of cross-linking polyethylene (XLPE) tibial inserts were investigated using a knee simulator, scanning electron microscopy (SEM), and a small punch test (SPT). Ultrahigh molecular weight PE made from GUR1050 resin was irradiated at doses ranging from 0 to 200 kGy and then machined into tibial inserts followed by annealing. The knee simulator was run for up to four million cycles. As the radiation dose increased from 0 to 100 kGy, the wear rate decreased dramatically, yielding 95% wear reduction at 100 kGy. The microwear features observed by SEM supported the dose-dependent wear reduction. The SPT for XLPE after the simulation test showed that, as the radiation dose increased from 0 to 200 kGy, the ultimate displacement decreased dose-dependently, while the ultimate load increased from 0 to 75 kGy and decreased from 75 to 200 kGy. The resulting toughness of the PE increased to its maximum at a dose of 50 kGy and then decreased with higher doses up to 200 kGy. PE cross-linked with radiation doses from 25 to 75 kGy had greater toughness than virgin, nonirradiated PE. However, PE irradiated with 100 kGy or more had lower toughness than virgin PE. These data suggest that a certain amount of irradiation enhances both wear performance and toughness of PE tibial inserts. Although a certain amount of cross-linking would be effective for clinical application of PE tibial inserts, an optimal radiation dose should be much smaller than that used in current XLPE in total hip arthroplasty.

Surface micro-analyses of long-term worn retrieved "Osteal" alumina ceramic total hip replacement.

We analyzed wear pattern of long-term retrieved alumina-alumina hip prostheses from Osteal, which were implanted for 15-19 years. A comparison was carried out with our previous study of 17-year Biolox alumina-on-alumina hip prostheses, (Shishido et al., J Biomed Mater Res B 2003;67:638-647) and all-alumina total hip replacement run under microseparation simulator tests. Of particular interest was the occurrence of stripe wear in these first generation alumina ceramic bearings. Two balls of Osteal revealed only one stripe wear as did the respective liners on their rim areas. In these latter balls, the stripes were shallower than those previously observed in Biolox implants. A microscopic analysis of the bearing surface was carried out using scanning electron microscopy and fluorescence microprobe spectroscopy. On average, the Osteal retrievals had one grade lower wear than Biolox retrievals. Fluorescence microprobe maps showed that Biolox ball surfaces had higher compressive stress than the Osteal likely due to severe impingement and microseparation promoted by the bulky implant design.

Wear and toughness of crosslinked polyethylene for total knee replacements: a study using a simulator and small-punch testing.

Severe loading and complex kinematics in total knee replacement make wear performance and toughness of the polyethylene in tibial inserts important. We investigated wear of crosslinked polyethylene using a knee simulator and measured toughness using small-punch testing. GUR1050 rods were gamma-irradiated in air at doses from 0 to 200 kGy, annealed in nitrogen, and machined into tibial inserts. The simulator was run to 4 million cycles, and wear rates determined from weight loss. Wear rate decreased by 54, 78, and 95% as radiation dose increased from 50 to 75 to 100 kGy, respectively. At every dose, toughness was significantly less after simulator testing, but the difference between control and wear-tested polyethylene, considered to be due to fatigue damage accumulation, was smallest at 50 kGy. The simulator-tested polyethylene that received 35 to 75 kGy had slightly higher toughness than equivalent material that received no irradiation. However, the toughness of simulator-tested polyethylene that received 150 and 200 kGy was lower than that of the simulator-tested polyethylene that received no irradiation. Our results suggest that an optimal irradiation dose may exist for crosslinked polyethylene for use in TKR and that the optimum dose would be less than the 100 kGy or more that are used in some current crosslinked polyethylene for hip replacement.

Improved wear performance with crosslinked UHMWPE and zirconia implants in knee simulation.

BACKGROUND: Suggestions for improved wear performance of total knee replacements have included replacement of standard CoCr femoral components with ceramic and replacement of 3.5-Mrad ultra-high molecular weight polyethylene (UHMWPE) inserts with 5- or 7-Mrad UHMWPE inserts. The ceramic materials used clinically have included alumina, zirconia ceramic and oxidized zirconium. PATIENTS AND METHOD: We compared both CoCr and zirconia versions of the Bi-Surface knee replacement in a 6-station knee simulator using alpha calf serum for lubrication (20 mg protein per mL) to evaluate the relative bearing performance. RESULTS: We studied the 4-way knee simulation of implant materials: zirconia ceramic, CoCr, 3.5-Mrad UHMWPE, and 7-Mrad UHMWPE. With CoCr femoral components, the 7-Mrad UHMWPE resulted in a 5- to 8-fold reduction in wear compared to the 3.5-Mrad insert. With the 3.5-Mrad insert, the zirconia bearing provided approximately 4-fold wear reduction compared to CoCr. These wear rates with standard UHMWPE were similar to published wear studies on entire knees. With the exception of the CoCr/7-Mrad and ZrO2/3.5-Mrad combinations, the wear differences were statistically significant. INTERPRETATION: The ZrO2/7-Mrad UHMWPE combination gave the best performance, with no measurable wear over the 5.5 million cycle test duration.

Effect of low protein concentration lubricants in hip simulators.

BACKGROUND: Proteins play an important role as boundary lubricants in vivo and in vitro. Hip simulator studies have tested various protein concentrations of lubricants. Several groups reported that nonphysiological pits were created with low protein concentrations. Our study showed details of wear findings with low protein concentrations. This may be the first mapping of the run-in wear morphology on ultra high molecular weight polyethylene (UHMWPE) cups. METHODS: The UHMWPE cups used were holding cobalt chrome (CoCr) balls. This study was run on orbital-type hip simulators at up to 1.0 million cycles (Mc). The lubricant was bovine calf serum (0, 3, 5, 7, 10, and 1 mg/ml protein concentrations). Two volumes of lubricant were used (40 and 16 ml). Volumetric wear rates were calculated and the cup surfaces were observed using reflected light microscopy (RLM) and scanning electron microscopy (SEM). RESULTS: The 40-ml volume showed a lower wear rate than the 160-ml volume. The RLM findings showed that the machine marks gradually disappeared up to 1.Mc, but there were no obvious pits on the polyethylene surface. The SEM findings showed nonphysiological wear phenomena in the 0-mg/ml protein concentration and physiological wear phenomena in the low protein concentrations. In the main bearing wear area, many nodules were observed with fibrils. In the peripheral bearing wear area, mainly ripples were observed. At the nonbearing wear area, folds were observed. CONCLUSIONS: Our study showed the microwear findings with low-protein serum: First, folds were formed, followed by ripples, and finally nodules accompanied by fibrils. During the run-in wear phase, nodules and fibrils had already appeared in the main bearing wear area. Thus, we need to investigate more details of the wear process when folds or ripples change to nodules at the main wear area in the run-in wear.