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Metrology to quantify wear and creep of polyethylene tibial knee inserts.

Assessment of damage on articular surfaces of ultrahigh molecular weight polyethylene tibial knee inserts primarily has been limited to qualitative methods, such as visual observation and classification of features such as pitting, delamination, and subsurface cracking. Semiquantitative methods also have been proposed to determine the linear penetration and volume of the scar that forms on articular surfaces of tibial knee inserts. The current authors report a new metrologic method that uses a coordinate measuring machine to quantify the dimensions of this scar. The articular surface of the insert is digitized with the coordinate measuring machine before and after regular intervals of testing on a knee simulator. The volume and linear penetration of the scar are calculated by mathematically taking the difference between the digitized surface maps of the worn and unworn articular surfaces. Three conventional polyethylene tibial knee inserts of a posterior cruciate-sparing design were subjected to five million cycles of normal gait on a displacement-driven knee wear simulator in bovine serum. A metrologic method was used to calculate creep and wear contributions to the scar formation on each tibial plateau. Weight loss of the inserts was determined gravimetrically with the appropriate correction for fluid absorption. The total average wear volume was 43 +/- 9 and 41 +/- 4 mm3 measured by the metrologic and gravimetric methods, respectively. The wear rate averaged 8.3 +/- 0.9 and 8.5 +/- 1.6 mm3 per million cycles measured by the metrologic and gravimetric methods, respectively. These comparisons reflected strong agreement between the metrologic and gravimetric methods.

Equipment Failure Analysis↗

Wear, debris, and biologic activity of cross-linked polyethylene in the knee: benefits and potential concerns.

Cross-linked polyethylene currently is being introduced in knee prostheses. The wear rates, wear debris, and biologic reactivity of non cross-linked, moderately cross-linked, and highly cross-linked polyethylene have been compared in multidirectional wear tests and knee simulators. Multidirectional pin-on-plate wear studies of noncross-linked, moderately cross-linked (5 Mrad), and highly cross-linked (10 Mrad) polyethylene showed a 75% reduction in wear with the highly cross-linked material under kinematics found in the hip, but only a 33% reduction under wear in kinematics representative of the knee. In knee simulator studies, with the fixed-bearing press-fit, condylar Sigma cruciate-retaining knee under high kinematic input conditions, the wear of 5 Mrad moderately cross-linked polyethylene was 13 +/- 4 mm per 1 million cycles, which was lower (p < 0.05) than the wear of clinically used, gamma vacuum foil GUR 1020 polyethylene (23 +/- 6 mm/1 million cycles). For the low-contact stress mobile-bearing knee, the wear of moderately cross-linked polyethylene was 2 +/- 1 mm per 1 million cycles, which was lower (p < 0.05) than GVF GUR 1020 polyethylene (5 +/- 2 mm/1 million cycles). The wear debris isolated from the fixed-bearing knees showed the moderately cross-linked material had a larger percentage volume of particles smaller than 1 mum in size, compared with GVF GUR 1020 polyethylene. Direct cell culture studies of wear debris generated in sterile wear simulators using multidirectional motion showed a increase (p < 0.05) in tumor necrosis factor-alpha levels and reactivity for GUR 1050 cross-linked polyethylene debris compared with an equivalent volume of noncross-linked GUR 1050 polyethylene. The use of cross-linked polyethylene in the knee reduces the volumetric wear rate. However, the clinical significance of reduced fracture toughness, elevated wear in abrasive conditions, and the elevated tumor necrosis factor-alpha release from smaller more reactive particles warrant further investigation.

Analysis of Variance↗

Fixation of revision implants is improved by a surgical technique to crack the sclerotic bone rim.

Revision joint replacement has poorer outcomes compared with primary joint replacement, and these poor outcomes have been associated with poorer fixation. We investigated a surgical technique done during the revision operation to improve access from the marrow space to the implant interface by locally cracking the sclerotic bone rim that forms during aseptic loosening. Sixteen implants were inserted bilaterally by distal femur articulation of the knee joint of eight dogs, using our controlled experimental model that replicates the revision setting (sclerotic bone rim, dense fibrous tissue, macrophages, elevated cytokines) by pistoning a loaded 6.0-mm implant 500 microm into the distal femur with particulate PE. At 8 weeks, one of two revision procedures was done. Both revision procedures included complete removal of the membrane, scraping, lavaging, and inserting a revision plasma-spray Ti implant. The crack revision procedure also used a splined tool to circumferentially locally perforate the sclerotic bone rim before insertion of an identical revision implant. Superior fixation was achieved with the cracking procedure in this experimental model. Revision implants inserted with the rim cracking procedure had a significantly higher pushout strength (fivefold median increase) and energy to failure (sixfold median increase), compared with the control revision procedure. Additional evaluation is needed of local perforation of sclerotic bone rim as a simple bone-sparing means to improve revision implant fixation and thereby increase revision implant longevity.

Animals↗

Highly cross-linked, electron-beam-irradiated, melted polyethylene: some pros.

Extensive new evidence generated within the past the year provides strong support for the use of electron-beam highly cross-linked, subsequently melted ultra-high molecular weight polyethylene in total hip replacement arthroplasty. In terms of wear reduction, three studies involving three different demographic groups and two different measurement techniques have found that the femoral head penetration with this type of polyethylene after bedding in has finished taking place is less than 10 micra per year. This wear rate is similar to the wear rate of metal-on-metal and ceramic-on-ceramic articulations. Retrieval specimens up to 3 years after insertion confirmed the minimal wear by exhibiting persisting machine marks throughout the inside diameter of the liner. Extensive studies show no evidence of oxidation, confirming the absence of residual free radicals. No evidence of fatigue failure exists except three known cases out of 150,000, in which malposition of the acetabular component produced abnormally high contact stresses on unsupported polyethylene. The in vivo wear, oxidation resistance, and mechanical properties of this alternative bearing material are excellent, with in vivo durations now exceeding five years. The other major advantages over hard-on-hard bearings including familiarity, adaptability, forgiveness, and cost seem to be compelling.

Adult↗

A new method for evaluation of cavitation near mechanical heart valves.

Evaluation of cavitation in vivo is often based on recordings of high-pass filtered random high-frequency pressure fluctuations. We hypothesized that cavitation signal components are more appropriately assessed by a new method for extraction of random signal components of the pressure signals. We investigated three different valve types and found a high correlation between the two methods (r2: 0.8806-0.9887). The new method showed that the cavitation signal could be extracted without a priori knowledge needed for setting the high-pass filter cut off frequency, nor did it introduce bandwidth limitation of the cavitation signal.

Algorithms↗

Transhepatic removal of obstructed Carey-Coons biliary endoprosthesis.

A criticism of the use of an endoprosthesis for relief of biliary obstruction has been the difficulty of removing or exchanging the endoprosthesis if it becomes obstructed. We present a simple method of removal that has been successful in four of five patients who presented with an obstructed endoprosthesis 3-7 months after placement.

Aged↗

Spinal fixation device: a 6-year postimplantation study.

Long-term tissue response to a metal device is described here. The components of a spinal fixation device were removed 6 years after implantation, following the need for revision surgery after a fall. Scanning electron microscopy (SEM) revealed changes in surface topography of the metal. Examination of the adjacent tissue showed a chronic inflammatory response with occasional metal debris. Immunohistochemistry identified the predominant macrophages and abundant neovascularization. The presence of macrophages in tissues adjacent to the implants, in an otherwise asymptomatic person, is noteworthy.

Bone Plates↗

Is there a role of statins in the prevention of aortic biological prostheses degeneration.

It has been recently observed that statins might slow the progression of aortic stenosis or sclerosis. Preliminary reports suggested a similar positive effect in reducing the degeneration of aortic valve bioprostheses even though this hypothesis should be further proven and supported by new data. In this review the present evidences of the possible effects of statins in this field are discussed.

Animals↗

The wear of metal-on-metal total hip prostheses measured in a hip simulator.

New generation metal-on-metal prostheses have been introduced to try and overcome the problem of osteolysis often attributed to the wear particles of the polyethylene component of conventional metal-on-ultra-high molecular weight polyethylene (UHMWPE) joints. The wear rates of four metal-on-metal joints (two different clearances) were assessed along with that of a conventional metal-on-UHMWPE joint. Friction measurements of the metal-on-metal joints were taken before and after the wear test and compared. Two distinct wear phases were discernible for all the metal-on-metal joints: an initial wear phase up to 0.5 x 10(6) cycles and then a lower steady state wear phase. The steady state wear rate of the 22 microm radial clearance metal-on-metal joint was lower than that for the 40 microm radial clearance joint, although this difference was not found to be significant (p > 0.15). The wear rates for all the joints tested were consistent with other simulator studies. The friction factors produced by each joint were found to decrease significantly after wear testing (p < 0.05).

Biocompatible Materials↗

Investigations on the wear behaviour of the temporary PMMA-based hip Spacer-G.

Total hip replacement has become one of the most successful orthopaedic procedures. However, complications due to infections may give serious problems and have devastating consequences for the hip implant. The use of a temporary three-dimensional polymethylmethacrylate (PMMA) cement spacer may be an alternative to solve infections in hip implants, improving the lives of patients awaiting reimplantation. In order to evaluate their wear behaviour, five PMMA Spacer-G femoral heads were tested against five post-mortem pelves in a hip joint simulator with bovine calf serum as lubricant. The surface of the worn spacers was characterized by scanning electron microscopy (SEM) analysis; all the samples revealed a similar morphology, showing areas characterized by different degrees of wear. Particle debris was isolated from the lubricant and PMMA particles and bone fractions were quantified. The amount of debris was found to be higher than where no-temporary prostheses were used. However, this result is acceptable since wear debris is removed by lavage irrigation when the Spacer-G is explanted. On the basis of these data, it is considered that the use of the cement Spacer-G could be a promising approach to the treatment of complicated infections of the hip joint. Therefore, Spacer-G is worthy of further research.

Arthroplasty, Replacement, Hip↗

Understanding the role of corrosion in the degradation of metal-on-metal implants.

In metal-on-metal joints the primary concerns in terms of long-term durability relate to corrosion, wear, and their joint (tribocorrosion) effects. The release of ions through corrosion processes and nanoscale debris from wear processes can seriously affect joint integrity and can lead to an adverse biological reaction by the host. In this paper an integrated study of corrosion-wear interactions in serum, Dulbecco's Modified Eagle's Medium and 0.3 per cent NaCl has demonstrated that the biological nature of the fluid affects the total degradation rate and also the level of wear-corrosion interactions. The specific action of proteins in corrosion and tribocorrosion for high-carbon Co-Cr-Mo and low-carbon Co-Cr-Mo alloys is discussed.

Absorbable Implants↗

Tribological principles in metal-on-metal hip joint design.

An analysis of some 100 published and communicated findings on running-in volumetric wear and steady state wear rates from simulator tests carried out in eight laboratories in three countries has been undertaken. Powerful indications have emerged of the dominant role of mixed lubrication in current metal-on-metal hip replacements, with elastohydrodynamic film thickness controlling wear. The background to the calculation of film thickness in the elastic-isoviscous mode of lubrication has been outlined and graphs of representative film thickness and lambda ratio have been presented. For minimum wear and wear rate the diameter of the femoral component should be as large as possible, while the clearance should be as small as is practicable. The findings are valid for both monolithic and surface replacement implants. A tentative proposal is made for the prediction of lifetime wear in metal-on-metal total hip replacements.

Biocompatible Materials↗

History and modern concepts in surface replacement.

Hip resurfacing is not a modern concept. Professor Sir John Charnley attempted the first hip resurfacing procedure in the 1950s. This implant failed as a result of unsatisfactory materials and the same problem has troubled hip resurfacing developments over the subsequent forty years. Modern hip resurfacing using metal-on-metal bearings has shown good medium-term results in the most challenging subgroup--young active patients.

Biocompatible Materials↗

Metal-on-metal hip joint tribology.

The basic tribological features of metal-on-metal total hip replacements have been reviewed to facilitate an understanding of the engineering science underpinning the renaissance of these hard-on-hard joints. Metal-on-polymer hip replacements operate in the boundary lubrication regime, thus leading to the design guidance to reduce the femoral head diameter as much as is feasible to minimize frictional torque and volumetric wear. This explains why the gold-standard implant of this form from the past half-century had a diameter of only 22.225 mm (7/8 in). Metal-on-metal implants can operate in the mild mixed lubrication regime in which much of the applied load is supported by elastohydrodynamic films. Correct tribological design leads to remarkably low steady state wear rates. Promotion of the most effective elastohydrodynamic films calls for the largest possible head diameters and the smallest clearances that can reasonably be adopted, consistent with fine surface finishes, good sphericity and minimal structural elastic deformation of the cup on its foundations. This guidance, which is opposite in form to that developed for metal-on-polymer joints, is equally valid for solid (monolithic) metallic heads on metallic femoral stems and surface replacement femoral shells. Laboratory measurements of friction and wear in metal-on-metal joints have confirmed their potential to achieve a very mild form of mixed lubrication. The key lies in the generation of effective elastohydrodynamic lubricating films of adequate thickness compared with the composite roughness of the head and cup. The calculation of the film thickness is by no means easy, but the full procedure is outlined and the use of an empirical formula that displays good agreement with calculations based upon the full numerical solutions is explained. The representation of the lambda ratio, lambda, embracing both film thickness and composite roughness, is described.

Arthroplasty, Replacement, Hip↗

The effect of microstructure on the wear of cobalt-based alloys used in metal-on-metal hip implants.

The influence of microstructure on the wear of cobalt-based alloys used in metal-on-metal hip implants was investigated in a boundary lubrication regime designed to represent the conditions that occurred some of the time in vivo. These cobalt-chromium-molybdenum alloys were either wrought, with a total carbon content of 0.05 or 0.23 wt %, cast with a solution-annealing procedure or simply as-cast but not solution annealed. Bars of these different alloy grades were subjected to various heat treatments to develop different microstructures. The wear was evaluated in a linear-tracking reciprocating pin-on-plate apparatus with a 25 per cent bovine serum lubricant. The wear was found to be strongly affected by the dissolved carbon content of the alloys and mostly independent of grain size or the carbide characteristics. The increased carbon in solid solution caused reductions in volumetric wear because carbon helped to stabilize a face-centred cubic crystal structure, thus limiting the amount of strain-induced transformation to a hexagonal close-packed crystal structure. Based on the observed surface twining in and around the contact zone and the potentially detrimental effect of the hexagonal close-packed phase, it was postulated that the wear of cobalt-based alloys in the present study was controlled by a deformation mechanism.

Biocompatible Materials↗

The tribology of metal-on-metal total hip replacements.

Total hip surgery is an effective way of alleviating the pain and discomfort caused by diseased or damaged joints. However, in the majority of cases, these joints have a finite life. The main reason for failure is osteolysis (bone resorption). It is well documented that an important cause of osteolysis, and therefore the subsequent loosening and failure of conventional metal- or ceramic-on-ultra-high molecular weight polyethylene joints, is the body's immunological response to the polyethylene wear particles. To avoid this, interest has been renewed in metal-on-metal joints. The intention of this paper is to review the studies that have taken place within different laboratories to determine the tribological performance of new-generation metal-on-metal total hip replacements. These types of joint offer a potential solution to enhance the longevity of prosthetic hip systems; however, problems may arise owing to the effects of metal ion release, which are, as yet, not fully understood.

Biocompatible Materials↗