An in vitro simulation model to assess the severity of edge loading and wear, due to variations in component positioning in hip joint replacements.

The aim of this study was to develop a preclinical in vitro method to predict the occurrence and severity of edge loading condition associated with the dynamic separation of the centres of the head and cup (in the absence of impingement) for variations in surgical positioning of the cup. Specifically, this study investigated the effect of both the variations in the medial-lateral translational mismatch between the centres of the femoral head and acetabular cup and the variations in the cup inclination angles on the occurrence and magnitude of the dynamic separation, the severity of edge loading, and the wear rate of ceramic-on-ceramic hip replacement bearings in a multi-station hip joint simulator during a walking gait cycle. An increased mismatch between the centres of rotation of the femoral head and acetabular cup resulted in an increased level of dynamic separation and an increase in the severity of edge loading condition which led to increased wear rate in ceramic-on-ceramic bearings. Additionally for a given translational mismatch, an increase in the cup inclination angle gave rise to increased dynamic separation, worst edge loading conditions, and increased wear. To reduce the occurrence and severity of edge loading, the relative positions (the mismatch) of the centres of rotation of the head and the cup should be considered alongside the rotational position of the acetabular cup. This study has considered the combination of mechanical and tribological factors for the first time in the medial-lateral axis only, involving one rotational angle (inclination) and one translational mismatch. © 2017 The Authors Journal of Biomedical Materials Research Part B: Applied Biomaterials Published by Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1897-1906, 2018.

Metal-carbon fiber composite femoral stems in hip replacements: a randomized controlled parallel-group study with mean ten-year follow-up.

BACKGROUND: Attempts to improve proximal load transfer and minimize stress shielding have included reducing the stiffness of femoral stems and using alternative stem materials, including carbon fiber composites. An uncemented implant (SR71) composed of a carbon-fiber-composite distal section and a porous-coated titanium-alloy proximal section, designed to improve proximal load transfer and provide good fixation, was clinically evaluated in a prospective randomized study. METHODS: Sixty patients were enrolled and randomized to receive either the SR71 stem or an all-metal stem (Stability). All patients received a cemented all-polyethylene acetabular component and a 28-mm metal femoral head. All uncemented stems were implanted by the same surgeon. Patients were followed for up to ten years with repeated assessments of bone mineral density, radiographs, Harris hip scores (HHS), and visual analog scale (VAS) pain scores. RESULTS: Ten years postoperatively, nineteen patients who had been treated with the SR71 stem and not lost to follow-up showed a significantly greater increase in proximal bone mineral density (Gruen zones 1 [p = 0.003] and 7 [p = 0.0007]) from baseline than did the twenty-two who had been treated with the Stability stem and not lost to follow-up. In contrast, the Stability group showed a significantly greater increase in distal bone mineral density (Gruen zones 2 [p = 0.0004], 3 [p = 0.0001], and 5 [p = 0.0035]) compared with the SR71 group. Radiographs demonstrated one case of progressive migration of an acetabular component used with an SR71 stem and one case of bone resorption in Gruen zones 7 and 14 in a patient treated with a Stability stem. There was no significant difference between the SR71 and Stability stems in terms of changes in the total HHS, HHS for pain, HHS for range of motion, or VAS pain scores ten years postoperatively relative to preoperative levels. There was one reported revision of an SR71 femoral stem at the ten-year review. CONCLUSIONS: The investigational SR71 implant provided increased proximal bone density and reduced distal bone density. The implant showed promising results at the time of early follow-up, and the clinical outcomes were similar to those of an all-metal stem at the time of a ten-year follow-up.

Ceramic-on-metal bearings in total hip replacement: whole blood metal ion levels and analysis of retrieved components.

This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole blood metal ion levels were measured. The median increase in chromium and cobalt at 12 months was 0.08 microg/1 and 0.22 microg/1, respectively, in CoM bearings. Comparable values for metal-on-metal (MoM) were 0.48 microg/1 and 0.32 microg/1. The chromium levels were significantly lower in CoM than in MoM bearings (p = 0.02). The cobalt levels were lower, but the difference was not significant. Examination of two explanted ceramic heads revealed areas of thin metal transfer. CoM bearings (one explanted head and acetabular component, one explanted head and new acetabular component, and three new heads and acetabular components) were tested in a hip joint simulator. The explanted head and acetabular component had higher bedding-in. However, after one million cycles all the wear rates were the same and an order of magnitude less than that reported for MoM bearings. There were four outliers in each clinical group, primarily related to component malposition.

The cemented custom femoral stem--a 10 year review.

We report a series of 706 patients (759 hip implants) with an average follow up of 10.5 years (range, 10-11 years) following total hip replacement (THR) using a cemented custom-made femoral stem and a cemented HDP acetabular component. The fate of every implant is known. One hundred and seventy-four patients (23%) were deceased at the time of their 10-year review all died with a functioning THR in situ. Four hundred and sixty-two patients (61%) were subsequently reviewed. One hundred and twenty three patients (16%) were assessed by telephone review, as they were too ill or unwilling to attend. Kaplan-Meier survival analysis (all components) demonstrated a median survival at 10 years of 96.05% or 95% Confidence Intervals (CI) for median survival of (94.41% to 97.22%). Revision surgery occurred in 30 cases (3.9%). Seventeen had full revisions (2.2%) and 13 (1.7%) socket revisions only. Twenty-one out of 30 revisions were for infection or dislocation. There were 2 cases (0.3%) of revision for aseptic loosening of the stem. The 10-year results of the custom femoral titanium stem are encouraging and compare well with other cemented systems.

Metal-on-metal bearings surfaces: materials, manufacture, design, optimization, and alternatives.

When first introduced, total hip replacements offered pain relief and improved mobility in elderly patients. The success of this procedure in terms of long-term durability and restoration of function has led to its use in younger, more active patients. This has resulted in a commensurate increase in patient expectation regarding longevity and the degree to which function and lifestyle is restored. The bearing surface is a key feature of the performance of replacement joints. It is generally accepted that excessive amounts of wear debris preclude their long-term survivorship and hence there is an ongoing requirement for bearing surfaces which minimize debris generation. The purpose of this paper is to review the factors which affect the performance of so-called metal-on-metal bearings, to compare their performance with that of the other commonly used contemporary alternatives, metal and ceramic articulating against highly cross-linked polyethylene, and ceramic-on-ceramic, and finally to consider the potential solutions offered by new developments such as ceramic-on-metal and coatings applied to metal-on-metal bearings.

Head replacement, head rotation, and surface damage effects on metal-on-metal total hip replacements: a hip simulator study.

The possibility of replacing the femoral head alone, in either solid or articular surface replacement form, during revision operations on metal-on-metal total hip replacements remains an attractive feature of such implants. In the present investigation, laboratory simulator studies of the influence upon volumetric wear of inserting a new femoral head, of introducing some head rotation, and of damaging the femoral head by scratches have all been explored. New and rotated heads both involve an additional running-in period, but the experimental studies show that the volumetric wear associated with this process is less than the initial running-in wear. The beneficial effects upon volumetric wear of small clearances have been confirmed, while the processing of high-carbon Co-Cr-Mo materials appears to be much less influential. Scratches did not affect wear as much as head replacement or head rotation, but the ongoing wear rates were somewhat higher.

Development rationale for an articular surface replacement: a science-based evolution.

Hip resurfacing has an enduring appeal because of the advantages of bone conservation and maximal joint stability. However, a far from satisfactory experience with earlier resurfacing designs led to its virtual disappearance in the 1980s. The concept was reintroduced in the late 1990s. The current generation of resurfacing devices generally consisted of a large-diameter metal-on-metal articulation, the femoral components being cemented and the acetabular components utilizing various forms of cementless fixation. The encouraging medium-term results, with a follow-up of up to 8 years using the current generation of surface replacement joints, combined with favourable reports related to long-term performance of some metal bearings have led to a rapid increase in the use of such components with these devices. This trend is most marked in younger, more active patients who have expectations of restoration of lifestyle in addition to improved mobility and pain relief and in whom failure with conventional total hip replacement is much higher than previously reported with more sedentary patients. The aim of this paper is, firstly, to highlight a number of areas of improvement and, secondly, to explain how these may be addressed by making modifications to the design of both implants and instrumentation and to the surgical technique. The areas identified for improvement were tissue preservation (thinner components, and reduced steps between sizes), acetabular cup issues (fixation, insertion, and positioning), femoral component issues (design, loading, and cementation), improved bearing surface characteristics, and simplified precise instrumentation with a low-trauma surgical technique.

Wear of surface engineered metal-on-metal hip prostheses.

The wear of existing metal-on-metal (MOM) hip prostheses (1 mm3/million cycles) is much lower than the more widely used polyethylene-on-metal bearings (30-100 mm3/million cycles). However, there remain some potential concerns about the toxicity of metal wear particles and elevated metal ion levels, both locally and systemically in the human body. The aim of this study was to investigate the wear, wear debris and ion release of fully coated surface engineered MOM bearings for hip prostheses. Using a physiological anatomical hip joint simulator, five different bearing systems involving three thick (8-12 microm) coatings, TiN, CrN and CrCN, and one thin (2 microm) coating diamond like carbon (DLC) were evaluated and compared to a clinically used MOM cobalt chrome alloy bearing couple. The overall wear rates of the surface engineered prostheses were at least 18-fold lower than the traditional MOM prostheses after 2 million cycles and 36-fold lower after 5 million cycles. Consequently, the volume of wear debris and the ion levels in the lubricants were substantially lower. These parameters were also much lower than in half coated (femoral heads only) systems that have been reported previously. The extremely low volume of wear debris and concentration of metal ions released by these surface engineered systems, especially with CrN and CrCN coatings, have considerable potential for the clinical application of this technology.

Changes in the contact area during the bedding-in wear of different sizes of metal on metal hip prostheses.

In metal on metal hip prostheses, the contact mechanics can influence the lubrication and wear rate. In particular, during the bedding-in wear, the contact area gradually increases to an optimal value, and the wear rate reduces as the contact stress reduces and the lubrication conditions improve. Geometrical designs that reduce the volume of bedding-in wear as the optimal contact area develops are preferable. The objective of this study was to analyse the wear volume as a function of contact area during the bedding-in period, with the aim of identifying geometrical design configurations that give lower bedding-in wear. As the radial clearance was reduced, the bedding-in wear volume to reach an optimal contact area also reduced. For a fixed radial clearance, increasing the head diameter also reduced the bedding-in wear volume.

An in vitro study of the reduction in wear of metal-on-metal hip prostheses using surface-engineered femoral heads.

Although the wear of existing metal-on-metal (MOM) hip prostheses (1 mm3/10(6) cycles) is much lower than the more widely used polyethylene-on-metal bearings, there are concerns about the toxicity of metal wear particles and elevated metal ion levels, both locally and systemically, in the human body. The aim of this study was to investigate the possibility of reducing the volume of wear, the concentration of metal debris and the level of metal ion release through using surface-engineered femoral heads. Three thick (8-12 microm) coatings (TiN, CrN and CrCN) and one thin (2 microm) coating (diamond-like carbon, DLC), were evaluated on the femoral heads when articulating against high carbon content cobalt-chromium alloy acetabular inserts (HC CoCrMo) and compared with a clinically used MOM cobalt-chromium alloy bearing couple using a physiological anatomical hip joint simulator (Leeds Mark II). This study showed that CrN, CrCN and DLC coatings produced substantially lower wear volumes for both the coated femoral heads and the HC CoCrMo inserts. The TiN coating itself had little wear, but it caused relatively high wear of the HC CoCrMo inserts compared with the other coatings. The majority of the wear debris for all half-coated couples comprised small, 30 nm or less, CoCrMo metal particles. The Co, Cr and Mo ion concentrations released from the bearing couples of CrN-, CrCN- and DLC-coated heads articulating against HC CoCrMo inserts were at least 7 times lower than those released from the clinical MOM prostheses. These surface-engineered femoral heads articulating on HC CoCrMo acetabular inserts produced significantly lower wear volumes and rates, and hence lower volumetric concentrations of wear particles, compared with the clinical MOM prosthesis. The substantially lower ion concentration released by these surface-engineered components provides important evidence to support the clinical application of this technology.

A comparison of the wear and physical properties of silane cross-linked polyethylene and ultra-high molecular weight polyethylene.

Cross-linked polyethylenes are being introduced widely in acetabular cups in hip prostheses as a strategy to reduce the incidence of wear debris-induced osteolysis. It will be many years before substantial clinical data can be collected on the wear of these new materials. Silane cross-linked polyethylene (XLPE) was introduced into clinical practice in a limited series of acetabular cups in 1986 articulating against 22.225-mm alumina ceramic femoral heads and showed reduced wear rates compared with conventionally sterilized (gamma irradiation in air) ultra-high molecular weight polyethylene (UHMWPE). We compared the wear of XLPE manufactured in 1986 with the wear of UHMWPE manufactured in 1986 in nonirradiated and irradiated forms. In the nonirradiated forms, the wear of XLPE was 3 times less than UHWMPE when articulating against smooth counterfaces. The nonirradiated materials did not show signs of oxidation. In the irradiated forms, only UHMWPE showed high levels of oxidation, and this caused a substantial increase in wear. Antioxidants added to XLPE during processing gave resistance to oxidative degradation. When sliding against scratched counterfaces, the wear of UHMWPE increased by a factor of 2 to 3 times. Against the same scratched counterfaces, the wear of XLPE increased dramatically by 30 to 200 times. This difference may be attributed to the reduction in toughness of XLPE. Clinically, XLPE has been articulated against damage-resistant ceramic heads, and this probably has been an important factor in contributing to reduced wear. New cross-linked polyethylenes differ considerably from XLPE. This study indicates that it is prudent to examine the wear of new polyethylenes under a range of conditions that may occur in vivo.

Radiographic assessment of the cement mantle thickness of the femoral stem in total hip replacement: a case study of 112 consecutive implants.

The results are reported of a radiographic study of cement mantle thickness in 112 consecutive primary hip replacements. Measurements were made by three observers of the apparent cement thickness medially and laterally using standard anterior-posterior radiographs. The average cement thickness was 3.2 mm, which is 1.2 mm greater than the size difference between the broach and the prosthesis, and was in the range 2-5 mm in 67 per cent of all measurement points. This has significance for the design of instrumentation to prepare the femoral cavity to give a defined cement mantle thickness. There was a greater cement mantle thickness proximally than distally. In 95 cases it was possible to determine the orientation of the stem within the cement mantle, which showed an even distribution between varus and valgus orientation; 49 per cent were within 1 degree of neutral and only one case was more than 5 degrees from neutral.

A comparative joint simulator study of the wear of metal-on-metal and alternative material combinations in hip replacements.

While total hip replacement represents the major success story in orthopaedic surgery in the twentieth century, there is much interest in extending even further, early in the twenty first century, the life of implants. Osteolysis has been identified as a major factor limiting the life of prostheses, with indications that fine polyethylene wear debris, generated primarily at the interface between the femoral head and the acetabular cup, promotes the process. There is therefore considerable interest in the introduction of alternative wear resistant systems to limit the deleterious effects of wear. These alternatives include ceramic-on-ceramic and metal-on-metal configurations and the present paper is primarily concerned with the latter. Some six pairs of new metal-on-metal implants of 36 mm diameter and four pairs of existing metal-on-metal implants of 28 mm diameter were tested in a ten-station hip joint simulator in the presence of a 25 per cent bovine serum solution. The implants were tested in the anatomical position to 5 x 10(6) cycles. The new heads and cups were manufactured from CoCrMo alloy with careful attention being paid to sphericity and surface finish of both components. The wear performance of the new and existing metal-on-metal total hip replacements have been evaluated and compared. The overall wear rates have then been compared with previously reported wear rates for a zirconia-on-polyethylene prosthesis of 22 mm diameter tested on the same simulator. The comparison is taken further by recalling published penetration data for metal-on-polyethylene implants of 22 and 28 mm diameter and converting these to volumetric wear rates. It was found that the heads and cups in metal-on-metal joints wore by almost equal amounts and that the opposing surfaces converged to similar surface roughness as the testing time increased. Steady state wear rates were generally achieved after 1-2 x 10(6) cycles. The mean long-term wear rates for the metal-on-metal prostheses were very low, being 0.36 mm3/10(6) cycles and 0.45 mm3/10(6) cycles for the new implants of 36 mm diameter and established implants of 28 mm diameter respectively. These wear rates compare with 6.3 mm3/10(6) cycles for zirconia-on-ultra-high molecular weight polyethylene tested on the same simulator and representative clinical values for metal-on-polyethylene of 36 mm3/year for heads of 22 mm diameter and a reported range of 60-180 mm3/year for 28 mm heads. These values do not translate directly into numbers of particles, since the metallic debris from metal-on-metal joints is very fine. The number of metallic particles may exceed the number of polyethylene wear particles from an otherwise similar metal-on-polyethylene joint by a factor of 10(3). A detailed discussion of the size and morphology of wear debris and tissue reaction to various forms of debris is beyond the scope of this paper, but the biological response to polymeric, metallic and ceramic wear debris forms a major subject for further study. The present investigation nevertheless confirms the potential of carefully designed and manufactured metal-on-metal total replacement joints for the treatment of diseased and damaged hips.

Comparison of the wear of aged and non-aged ultrahigh molecular weight polyethylene sterilized by gamma irradiation and by gas plasma.

The wear of ultrahigh molecular weight polyethylene in artificial joints is a major cause of long-term osteolysis and loosening. The wear rate of aged and non-aged ultrahigh molecular weight polyethylene sterilized by both gamma irradiation in air and gas plasma has been studied in simple configuration wear tests. Fourier transform infrared analysis (FTIR) showed marked oxidative degradation of the irradiated and aged material compared to the gas plasma sterilized and aged material. The wear rate of the irradiated and aged material was significantly (three times) higher than the gas plasma sterilized, gas plasma sterilized and aged, and non-sterilized materials. Alternative sterilization procedures such as gas plasma, when used instead of gamma irradiation in air, are likely to reduce the incidence of long-term osteolysis.

The wear of ultra-high molecular weight polyethylene sliding on metallic and ceramic counterfaces representative of current femoral surfaces in joint replacement.

A number of studies have investigated the influence of surface roughness on the wear of ultra-high molecular weight polyethylene (UHMWPE) in total joint replacement. The results of these studies have shown that the wear factor is proportional to the counterface roughness raised to a power greater than one. In this laboratory study, the effect of surface finish of several biomaterials on the wear of UHMWPE was studied. The study was conducted using reciprocating pin-on-plate wear tests with bovine serum as a lubricant. The biomaterials investigated as the counterface material included stainless steel, cast cobalt chrome (CoCr), CoCr (ASTM F799), alumina ceramic and zirconia ceramic. The counterface topographies of the wear plates were produced using techniques representative of current manufacturing methods. The surface roughness of the wear plates was varied in the range Ra = 0.005-0.04 micron; this was representative of femoral heads and femoral knee components currently used clinically. Metals and ceramics with a similar surface roughness produced a similar wear rate of UHMWPE. For the limited range of smooth counterfaces used in this study only a moderate correlation was found between the surface roughness and the wear factors. For a change in counterface roughness Ra of 0.005 to 0.04 micron, the wear factor increased from 7.4 +/- 1.6 to 16.5 +/- 2.4 x 10(-9) mm3/N m (mean +/- standard error). This variation in counterface roughness had much less effect in wear than previously reported for rougher counterfaces. For an extended range of counterface roughness, a stronger correlation was found using an exponential function for the regression fit. The exponential function shows the benefits of decreased wear with decreased surface roughness. Although the wear rate decreased less rapidly with decreased counterface roughness for Ra values below 0.05 micron, there were significant advantages to be gained from improved femoral head roughness to below 0.01 micron Ra.

An investigation into the origins of time-dependent variation in penetration rates with Charnley acetabular cups--wear, creep or degradation?

The total penetration of femoral heads into acetabular cups is achieved by a combination of long-term wear and early non-recoverable deformation or creep. The former is important in determining the total rate of production of polyethylene wear debris, recently implicated in the development of osteolysis and loosening, while the latter contributes to the overall penetration and the possibility of neck impingement in some designs of implants. Attention is drawn to the need to evaluate and to separate out these two physical processes in the assessment of clinical penetration rates. This is particularly important with more recent designs and combinations of materials, which are capable of operating with much reduced wear rates. Measurements of the penetrations of metallic femoral heads into polyethylene acetabular cups in 87 explanted Charnley hip arthroplasties from 85 patients are reported and assessed. The vast majority of the acetabular cups had been sterilized by gamma irradiation and the established shadowgraph technique was used to determine the penetrations. The average implantation time was 8.75 years, with a range from 0.2-18.6 years and the average age was 55 years, covering the span 19-73 years. The influence of sterilization procedure, implantation time and patient age are considered. Assessments of the relative magnitudes of wear and non-recoverable deformation are made by different statistical techniques and compared with previously reported data from clinical and laboratory studies.

The influence of scratches to metallic counterfaces on the wear of ultra-high molecular weight polyethylene.

A number of studies of explanted metallic femoral heads have shown scratches or damage caused by bone cement, bone or metallic particles. This damage has been cited as a cause of increased wear of ultra-high molecular weight polyethylene (UHMWPE) acetabular cups. In this laboratory study, small scratches 2 mu m deep were made on smooth stainless steel surfaces at a spacing of 10 mm. These individual scratches were found to increase the wear rate of UHMWPE by a factor of 30 in unidirectional sliding and a factor of 70 in reciprocating motion. It is of particular concern that a single small scratch, which is not detected by the average surface roughness measurement Ra can cause such a dramatic increase in the wear of ultra-high molecular weight polyethylene.

A tribological study of retrieved hip prostheses.

One hundred Charnley cemented acetabular cups, 78 of which had the associated femoral stems, were obtained after revision surgery. Patient characteristics, which were obtained from hospital records, and roentgenographs showed that component loosening was the most common cause of failure. Examination of the acetabular cups revealed six categories of damage: socket erosion, rim wear, cement ingress, cratering, discoloration, and articulating surface scoring. Damage to the femoral stems was characterized by stem fracture and roughening of the femoral head. The latter was predominantly caused by the roentgenographic contrast medium within the acrylic cement scratching the articulating surface. The amount of wear, in terms of the penetration of the femoral head into the acetabular cup, could be measured in 87 cases. The mean penetration was 1.69 mm and the mean penetration rate was 0.21 mm per year with a range from less than 0.005 mm to 0.6 mm per year. It was shown that within this group, a high penetration rate precludes a long service life. It is therefore likely that reducing the rate of wear would improve the performance of the artificial hip joint.

Polyethylene wear from retrieved acetabular cups.

Laboratory wear testing of ultra high molecular weight polyethylene from 12 Charnley acetabular cups, removed after periods of up to 17.5 years showed that the large patient-to-patient variations in clinical penetration rate cannot be explained by batch-to-batch variation in the wear resistance of the material. Nor was there any evidence of a time-dependent degradation in wear resistance of the material.