Osteolysis induced by UHMWPE debris has historically been one of the major causes of long term failure of TJR. An increase in concentration of polyethylene particles in the peri-prostheic tissue has been linked to an increased incidence of osteolysis. The dual mobility hip bearing concept mates a femoral head into a polyethylene liner which has an unconstrained articulation into a metal shell. The wear mechanism of the dual mobility hip bearing is distinct from a constrained single articulation design, which may result in a difference in wear debris particles. The aim of this study is to evaluate wear debris generated from a dual mobility hip and compare it to a conventional single articulation design when both are manufactured from sequentially crosslinked and annealed polyethylene. The dual mobility hip (Restoration ADM) incorporated a 28mm CoCr femoral head into a polyethylene liner that articulates against a metal shell (48mm ID). The conventional hip (Trident®) mated a 28mm CoCr femoral head against a polyethylene liner. The polyethylene for all liners was sequentially crosslinked and annealed (X3). A hip joint simulator was used for testing at a rate of 1 Hz with cyclic Paul curve physiologic loading. A serum sample from each testing group was collected. Serum samples were protein digested following the published process by Scott et al. The digested serum was then filtered through a series of polycarbonate filter papers of decreasing size and sputter coated with gold for analysis using SEM. Image fields were randomized and wear debris was compared in terms of its length, width, aspect ration, and equivalent circular diameter (ECD). A total of 149 conventional hip particles and 114 dual mobility hip particles were imaged. Results show a majority of particles are of spherical nature and images do not indicate the presence of fibrillar or larger elongated polyethylene debris. Particle length between designs is not statistically different, while all other comparisons show statistical significance (p<0.05). It is hypothesized that the dual mobility hip system reduces the total amount of cross-shear motion on any one articulation, which aids in the reduction in wear. This design feature may be responsible for the slight difference in morphology of dual mobility wear debris when compared to the constrained hip design. The length of the particles was similar, simply indicating a different shape rather than a marked reduction in overall size. The debris generated is this study was from highly crosslinked polyethylene in two different designs, which produced a very significant decrease in quantity of particles when compared to the quantity of debris from conventional polyethylene. The wear debris was of similar length in both designs and so we do not expect any difference in biological response to debris from either device. The dual mobility design has also shown no effect of cup abduction angle on wear demonstrating forgiveness to implant positioning. This advantage, combined with the low wear rate and similar length wear particles, should lead to good clinical performance of dual mobility cups with sequentially irradiated and annealed polyethylene

Background. Wear particles are considered to be the major culprit for the aseptic loosening. Their characterization is thus crucial for the understanding of their bioreactivity and contribution to the development of aseptic loosening. Methods. Metal wear debris particles were analyzed directly in periprosthetic tissue resins by scanning electron microscopy (SEM) combined with back-scattered electron imaging (BSE) and energy dispersive X-ray spectroscopy (EDS). Four groups of tissue samples retrieved at revision operations of loosened hip implants with different bearing surfaces (metal-on-metal, ceramic-on-polyethylene and metal-on-polyethylene), and different material of the femoral stem (Ti alloy, CoCrMo and polymer combined with stainless steel) were investigated. Tissue samples were first analyzed histologicaly. Sections from the same paraffin blocks were then carbon coated and analyzed using SEM/BSE/EDS method. Results. Metal particles were detected in all samples. Their composition corresponded to the composition of the implant components. The gradation of metal particles ranged from +1 to +3. A considerable number of big metal particles were actually agglomerates of submicron particles visible only at higher magnification. The clustering of particles was observed primarily for CoCrMo and, to a lesser extent, for stainless steels particles. The median sizes of CoCrMo clusters in two groups of samples were 2.9 1.8 m (range, 0.5 to 7.6 m) and 3.2 1.0 m (range, 1.9 to 5.4 m). The effect of clustering was not observed for Ti particles. The median sizes of individual Ti particles determined in two groups of samples were 2.5 3.6 m (range, 0.4 to 17.3 m) and 4.3 2.8 m (range, 0.8 to 11.0 m). Conclusion. Scanning electron microscopy combined with back-scattered electron imaging is an appropriate and selective method to recognize metal particles in tissue sections, without being destructive to specimens. When the size of the particles is considered, however, it should be differed between the size of individual particles and size of clusters of particles. Besides its benefits, this study has some limitations: the detection of particles smaller than 0.4 m is difficult, and this method cannot be used to identify polyethylene particles

MHRA guidance for patients with metal on metal hip replacements (MOM) was provided in 2012 and updated in 2017 to assist in the early detection of soft tissue reactions due to metal wear debris. A large number of metal on metal hip replacements were undertaken at our trust. A program of recall for all patients with metal on metal hip replacements was undertaken and MHRA guidelines implemented. Identification and recall of all patients from 2001 with MOM hip replacements using theatre logs, patient records and consultant log books. Two consultant review of X-rays and patient records. Postal questionnaires and GP requests for cobalt & chromium blood tests. Two consultant led MOM review clinics undertaken with metal artefact reduction scans (MARS) performed following consultation in 2017. 674 patients, 297 available for review. 59 refused follow up. 87 moved out of area, 36 untraceable, 26 not MOM, 147 RIP, 22 already revised. From 297 patients 126 female, 171 male, age range 39 – 95 yrs. 126 resurfacing, 171 MOM THR. 26 patients with elevated metal ions, MARS performed of which 17 positive, 9 negative. Of 17 positive scans 10 patients asymptomatic, 7 waiting revision. A time consuming effort and additional resource was needed and supported by the trust. From 297 hips 17 positive MARs were identified (5.7%). A new database registry has been developed to track MOM patients, clinics set up for ongoing follow up with radiological protocols for imaging. An arthroplasty advanced nurse practitioner (ANP) is now trained reviewing patients independently

Osteoporosis following ovariectomy has been suggested to modulate bone response to polyethylene wear debris. In this work, we evaluate the influence of estrogen deficiency on experimental particle-induced osteolysis. Polyethylene (PE) particles were implanted onto the calvaria of wild-type (WT), sham-ovariectomized (OVX), OVX mice and OVX mice supplemented with estrogen (OVX+E2) (12 mice per group). Sham-implanted mice served as internal controls. After 14 days, seven skulls per group were analyzed with a high-resolution micro-computed tomography (CT) and by histomorphometry, and for tartrate-specific alkaline phosphatase. Five calvariae per group were cultured for the assay of IL-1, IL-6, TNF- and RANKL secretion using quantitative ELISA. The expression of RANKL and OPG mRNA were evaluated using real-time PCR. As assessed by CT and by histomorphometry, PE particles induced an extensive bone resorption and an intense inflammatory reaction in WT, sham-OVX and OVX+E2 mice. In OVX mice group, these features appeared considerably attenuated. In WT, sham-OVX and OVX+E2 mice, PE particles induced an increase in serum IL-6, in TNF-and RANKL local concentrations, and resulted in a two-fold increase in RANKL/OPG mRNA ratio. Conversely, these parameters remained unchanged in OVX mice after PE implantation. The combination of two well-known bone resorptive mechanisms ultimately attenuated osteolytic response, suggesting a protective effect of estrogen deficiency on particle-induced osteolysis. This paradoxical phenomenon was associated with a downregulation of pro-resorptive cytokines. It is hypothesized that excessive inflammatory response was controlled, illustrated by the absence of increase of serum IL-6 in OVX mice after PE implantation

Background. Pseudotumours have been associated with metal-on-metal (MoM) hip replacements. We define it as a solid mass which may have cystic components that is neither neoplastic nor infectious in aetiology. The cause of a pseudotumour is not fully understood but could be due to excessive wear, metal hypersensitivity or due to an as-yet unknown cause. Aim. We present the retrieval analysis of early failure MoM hips revised for pain, loosening or a symptomatic mass. Tissues and implants were examined for the possible causes of failure and pseudotumour formation. Corrosion as a potential new cause for pseudotumour formation will be presented. Methods. A group of 16 MoM hip replacements were collected for retrieval analysis. Six of which had a pseudotumour. An Artificial Hip Profiler (Redlux Ltd) was used to measure wear. Edge loading was determined using the 3D wear data. Tissues were histologically evaluated using a 10-point ALVAL scoring system, which strongly suggests hypersensitivity (1). Cases were assigned to one of three categories: high wear (rates >5m/yr), hypersensitivity or corrosion. Results. Of the 6 pseudotumours, 3 had edge loading, 2 had high ALVAL scores and one had corrosion at the head taper junction. The high wear group, (3 cases) all demonstrated edge loading. Histology revealed more metal wear particles and macrophages, with a low ALVAL score in these cases. Two cases were found to have hypersensitivity with a high ALVAL score, more lymphocytes with less visible wear debris and macrophages. The wear rates were also lower, <4m/yr. One total hip replacement had corrosion at the junction between the head and adaptor taper for the stem. The bearings had low wear and the tissue had extensive necrosis as well as products of corrosion enclosed in fibrin (2). There was no suggestion of hypersensitivity (low ALVAL score). Conclusion. Pseudotumours can be caused by high wear, but if this is ruled out, a hypersensitivity or corrosion product reaction should be considered

Introduction. The MITCH PCR is an anatomic, flexible, horse-shoe shaped acetabular component, with 2 polar fins. The rationale of the PCR cup design is to reproduce a near-physiological stress distribution in the bone adjacent to the prosthesis. The thin composite cup is designed to fuse and flex in harmony with the surrounding bony structure. Only the pathological acetabular cartilage and underlying subchondral bone of the horseshoe-shaped, load-bearing portion of the acetabular socket is replaced, thus preserving viable bone stock. The PCR is manufactured from injection moulded carbon fibre reinforced polyetheretherketone (PEEK), with a two layer outer surface comprising hydroxyapatite and plasma sprayed commercially pure titanium. It is implanted in conjunction with a large diameter low wear femoral head, producing a bearing that will generate minimal wear debris with relatively inert particles. Pre-clinical mechanical testing, finite element analysis and biocompatibility studies have been undertaken. FEA evaluation predicts preservation of host bone density in the load bearing segments. A pilot clinical study was completed on a proto-type version of the PCR cup (the “Cambridge” cup), achieving excellent 5 and 10 year results. Subjects and Methods. We report the three-year results from a two-centre, prospective clinical evaluation study of the MITCH PCR cup. Patient outcome has been assessed using standardised clinical and radiological examinations and validated questionnaires. The change in physical level of activity and quality of life has been assessed using the Oxford Hip Score, Harris Hip score and the EuroQol-5D score, at scheduled time-points. Serial radiographs have been analysed to monitor the fixation and stability of the components. Results and Conclusions. In total 25 PCR cups were implanted by 3 surgeons. There were 12 men and 13 women. The mean patient age at time of surgery was 67 years (range 57–74). An Accolade TMZF stem was used as the femoral component in 19 patients and an Exeter stem in 6. The mean Oxford Hip score improved from 19.8 pre-operatively to 45 at the latest follow-up. The mean Euroqol-5D score improved from 62.6 to 83.6 and the Harris Hip score improved from 49.9 to 90.6. Three adverse events were noted in 2 patients (2 chest infections and 1 deep vein thrombosis). One revision of the acetabular component was performed at 21 months for squeaking. This has been investigated and modification of the articular geometry has resolved the problem on in-vitro testing

Introduction. The advantages of metal on metal (MOM) hip replacement are decreased wear rate, preservation of bone stock, anatomical restoration and enhanced stability. Large amounts of metal wear particles and metal ions are released which may induce adverse reactions including local soft tissue toxicity, hypersensitivity reactions, bone loss and risk of carcinogenesis. Aseptic loosening can be the result of a peri prosthetic osteolysis generated as a result of a biological response to particulate wear debris. Our aim in this study was to determine whether a steeply inclined acetabular component would give rise to a higher concentration of metal ions. Patients and methods. Between April 2003 and June 2006, 22 patients had MOM hip replacement for osteoarthritis by a single Surgeon. There were 12 male and 10 female patients. The average age at the time of surgery was 56 years (Range: 44–69 years). We divided the 22 patients into 2 groups, one group (A) of 11 patients with the acetabular inclination angle more than 50 degrees and the other group (B) of 11 patients with the angle less than 50 degrees. The inclination of the acetabular cup was measured using a standard AP radiograph of the pelvis. The patients had metal ion levels (blood chromium and serum cobalt) measured at an average follow up of 3.2 years (Range 2.4 to 5 years). Results. Mean blood chromium level in the group A (146 nM/L) was significantly higher (p=0.005) than in Group B (92 nM/L). Mean serum cobalt level in the group A (245 nM/L) was significantly higher (p=0.002) than in Group B (110 nM/L). Discussion. The early to mid term published results of MOM hip replacements have been encouraging. There are, however, a number of concerns about the MOM bearing. Although its wear rate is low, it still releases metal ions into the body particularly cobalt and chromium since most metal on metal bearings are made of a cobalt chromium alloy. The long-term consequences of increased levels of these ions in the body are not known. High concentrations of Co and Cr are toxic and are known to interfere with a number of biological functions. There also have been recent reports of soft tissue reactions with MOM hip replacement. In the light of these concerns, it is important to examine factors which may influence the release of metal ions after MOM hip replacement. It has been reported in the recent literature that the position of the acetabular component will influence the bearing wear inturn leading to the release of metal ions after MOM hip replacement. Our findings indicate that steeply inclined acetabular components with an inclination angle greater than 50 degrees gives rise to higher concentration of metal ions

INTRODUCTION. The advantages of large diameter metal on metal total hip arthroplasty (MoM THA) and hip resurfacing arthroplasty are decreased wear rate, preservation of bone stock, anatomical restoration and enhanced stability. Large amounts of metal wear particles and metal ions are released which may induce adverse reactions including local soft tissue toxicity, hypersensitivity reactions, bone loss and risk of carcinogenesis. Aseptic loosening can be the result of a peri-prosthetic osteolysis generated as a result of a biological response to particulate wear debris. No reports in the literature exist as to whether circulating levels of Chromium (Cr) and Cobalt (Co) decrease upon removal of a symptomatic large diameter MoM implant or whether levels remain high due to the effect of metal ions debris left behind in the soft tissues after revision surgery. PATIENTS AND METHODS. Between June 2006 and June 2009 we undertook 44 revision surgeries of both large head MoM THAs (femoral head diameter 38mm) and metal-on-metal hip resurfacings for suspected metallosis. Mean time from original implant to revision was 4 years, 8 months (1yr 4mo–7yr 9mo). The mean follow up evaluation was 2 years and 2 months (1yr 2mo–4 years). Blood samples were taken for whole blood Cr and serum Co according to a recognised protocol and compared with reference levels indicated by the Medicines and Healthcare Regulatory Agency recommendation of less than 7ppb for Cr (130nM/L) and Co (119nM/L). RESULTS. 42 patients were found to have histological evidence of either metal allergy, metal toxicity or foreign body reaction. 2 patients had evidence of infection with no features of metal reaction. 3 patients suffered early dislocation requiring closed reduction. 1 patient had infective complications necessitating Girdlestones. 11 patients were lost to follow up, 8 patients were diagnosed pre operatively on Co and Cr levels in urine or synovial fluid aspirate alone. 23 patients had pre revision blood or serum metal ion level results available for direct comparison. Median serum Co level pre revision was 176.6nM/L, falling post revision to 5.1nM/L (p=<0.001∗). The median whole blood Cr level pre revision was 117nM/L and 19nm/L post revision (p=<0.001∗). Mean Oxford Hip Score was 23.7. DISCUSSION. This study demonstrates that at greater than one year post removal of a large diameter MoM hip implant for the indication of symptomatic metallosis or metal hypersensitivity, metal ion levels fall to almost normal levels and that outcome of revision surgery in terms of patient satisfaction is not adversely affected

Introduction. In total hip arthroplasty ceramic on ceramic bearing couples are used more and more frequently and on a wordwide basis. The main reason of this choice is reduction of wear debris and osteolysis. The tribological properties and the mechanical behaviour of the implanted ceramic must remain the same throughout the patient's life. The aim of this study was to evaluate the resistance of Alumina Matrix Composite to environmental degradation. Material and method. The alumina matrix composite or BIOLOX ® delta is manufactured in Germany by CeramTec. It is made up of 80 vol.% Al2O3, 17 vol.% Yttria Stabilized ZrO2 and 3vol.% strontium aluminate platelets. The zirconia grains account for 1.3 mol.% of the Yttria content. Accelerated aging tests in water steam at 142°C, 134°C, 121°C, and 105°C were performed to evaluate the aging kinetics of the composite. X-ray diffraction was used to determine the monoclinic phase content on the material surface. Phase transformation is associated with weakness and increase in roughness of zirconia ceramic implants. Results. The data below shows average monoclinic contents before and after aging in water vapour according to the ISO standard test (134°C, 2 bars water steam, 10 h) on the surface and inside the 28 mm taper(12/14 taper) femoral ball heads manufactured in alumina ceramic composite. There are precisions concerning the roughness and the load to failure before and after aging concerning 28mm diameter heads. Before Aging 13%+/-3% of Monoclinic content. After 10 H at 134°C23%+/-3% of Monoclinic content the roughness of the polished surface remain the same (5nm+/− 2). The load to failure of 28 mm heads before aging is 76 kN +/− 5kN, and 72 kN +/− 5kN after aging. The results show that although a rise in monoclinic content is predictable after long aging duration in vivo, the impact of the transformation is quite different to monolithic zirconia. A zirconia femoral head exhibits an important increase of roughness from 2 nm to more than 50 nm when submitted to the same duration of ageing. Other tests with hip simulators under severe micro separation have been done to analyse the impact of aging on wear performance. The main wear zone on femoral heads underwent a phase transformation from tetragonal to monoclinic (23% monoclinic) at 5 milion cycles duration without any change in roughness after 5Mc duration. Conclusion. This experimental testing program has enabled a prediction for the long-term in vivo environmental resistance of prostheses made out of Alumina Matrix Composite. The substantial improvement in mechanical properties and the excellent wear behaviour, even under severe microseparation conditions has been clinically confirmed. Today more than 960,000 ceramic ball heads and more than 450 000 ceramic inserts made of the alumina matrix composite have been implanted. Additionally, due to enhanced mechanical behaviour, new applications in orthopaedics are possible

The prevalent cause of implant failure after total joint replacement is aseptic loosening caused by wear debris. Improvement of the wear behaviour of the articulating bearing between the cup and femoral head is essential for increased survival rate of artificial hip joints. Cross-linking of the polyethylene (PE) material is one attempt to reduce wear particle release at the articulating surface. Various cross-linked polyethylenes (X-PE) are used in orthopaedics since several years. In total hip arthroplasty (THA) the use of larger femoral head sizes has specific reasons. Larger heads lead to a decreased risk of total hip dislocation and impingement as well as an improved range of motion in comparison to smaller head sizes like 28mm or less. However, the increasing diameter of femoral head can be associated with lower thickness of the PE liner and increased wear rate. Cross-linking of PE can improve the wear rate of the liner and hence supports the use of larger femoral heads. The aim of this experimental study was to evaluate the wear of standard vs. sequential X-PE (X3-PE) liner in combination with different ceramic femoral head sizes. Wear testing was performed for 5 million load cycles using standard UHMW-PE liners (N2Vac) and X3-PE liners (each Stryker GmbH & Co. KG, Duisburg, Germany) combined with 28mm ceramic ball heads and the Trident PSL acetabular cup (Stryker). Furthermore, X3-PE liners with an internal diameter of 36mm and 44mm and decreased wall thickness (5.9mm and 3.8mm) were combined with corresponding ceramic heads. An eight station hip wear simulator according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany) was used to carry out the standard wear tests. The tests were realised in temperature-controlled chambers at 37°C containing calf serum (protein content 20g/l). The average gravimetrical wear rates of the standard UHMW-PE (N2Vac) liners combined with 28mm ceramic heads amounted to 12.6 ± 0.8mg/million cycles. Wear of X3-PE liners in combination with 28 mm ceramic heads was not detectable. The average gravimetrical wear rates of the X3-PE liners in combination with 36mm and 44mm ceramic heads amounted to 2.0 ± 0.5mg and 3.1 ± 0.3mg/million cycles, respectively. The purpose of this study was to evaluate the effect of femoral head size at THA on standard and sequential X-PE liner. The wear simulator tests showed that the wear rate of PE liners with small heads (28mm) decreased by cross-linking of the PE significantly. The amount of wear at X-PE increased slightly with larger head size (36mm and 44mm). However, by sequential cross-linking, the wear rate using thinner liners and larger femoral heads is reduced to a fractional amount of wear at conventional UHMW-PE. Hence, the above-mentioned advantages of larger femoral head diameters can be realised by improved wear behaviour of sequential X-PE

Due to increased life expectancy of human population, the amount of total knee replacements (TKR) is expected to increase. TKR reached a high grade of quality and safety, but most often it fail because of aseptic implant loosening caused by polyethylene (PE) wear debris. Wear is generated at the articulating surfaces, e.g. caused by three body particles, like bone fragments or bone cement particles. The aim of this experimental study was to compare the wear of tibial PE inserts combined with metallic and ceramic femoral components at three body wear situation induced by polymethylmethacrylate (PMMA) and zirconia (ZrO2) particles from the bone cement. Wear testing was performed for 5 Mio load cycles, using tibial standard PE inserts combined with the same CR femoral component, in two different materials, Cobalt Chromium (CoCrMo) and Biolox delta ® ceramic (Multigen Plus Knee System, Lima Corporate, Italy). A knee wear simulator, according to ISO 14243 (EndoLab GmbH, Rosenheim, Germany), was used to carry out the tests. The tests were performed in temperature-controlled test chambers at 37 °C, containing calf serum with a protein content of 30 g/l. Polymethylmethacrylate (PMMA) and zirconia (ZrO2) bone cement particles (Palacos R ®) were manufactured to a size of 30 μm. The three body particles were added at all stations onto the articulating surface of the tibial PE insert (7mg per condyle) at every 500,000 cycles. Wear was determined gravimetrically and the surfaces of tibial inserts were analysed by scanning electron microscope (SEM) after finishing the 5 million cycles. Furthermore, roughness of the PE insert surfaces and the articulating surfaces of the different femoral components were detected and the PE wear particles were analysed by SEM. The average gravimetrical wear rates of the tibial PE inserts in combination with CoCr and Biolox delta ® ceramic femoral components amounted to 6.4 ± 0.9 mg and 2.6 ± 0.4 mg per million cycles, respectively. Beside bone cement particles on the articulating surface of the PE inserts, polished surfaces and scratches were detected by SEM. In comparison to the untreated surfaces of the PE inserts at both material pairings the surface roughness at the articulating areas showed deep scratches and polished regions. Analyses of the metallic femoral components showed scratches at the articulating surfaces, none on ceramics. The present study pointed out the effect of femoral component material in an abrasive three body wear situation on the wear properties of TKR. The wear simulator tests showed that wear of PE inserts under three body wear conditions, in combination with ceramic femoral components, was significantly lower than with metallic femoral components. With regard to anti-allergic properties, ceramic femoral components are promising products for TKR