Introduction. Patients suffering from finger joint pain or dysfunction due to arthritis and traumatic injury may require arthroplasty and joint replacement. Single-part silicone-based implants remain the material of choice and most widely used option, although reports on their long-term clinical performance are variable. For trauma indications, patients have a high expectation of functionality necessitating the use of materials with high wear resistance and mechanical performance. A new proximal inter phalangeal (PIP) joint designed by Zrinski AG (Wurmlingen, Germany), comprising a self-mating carbon fibre reinforced polyetheretherketone (CFR-PEEK) coupling, may provide a suitable alternative. Here we describe the wear performance of the CFR-PEEK components in a PIP joint wear simulator and subsequent characterisation of the wear particles. Methods. Four proximal and distal PIP components were milled (Zrinski AG) from CFR-PEEK (Invibio Ltd, UK) and subjected to wear testing (Endo Lab ® GmbH, Germany). The test was conducted at 37°C over 5 million cycles in 25% bovine serum (refreshed every 0.5 million cycles). The load was a static force of 63N applied at a frequency of 1Hz with a flexion/extension angle of ±40°. Wear rate was determined by mass loss from each component. Pooled serum samples from the wear simulator were subjected to protein digest and the remaining particulate debris isolated by serial filtration through 10μm, 1μm and 0.1μm filters. Particle size and morphology was subsequently determined by scanning electron microscopy (SEM) (Continuum Blue, UK). Results. Both components exhibited high resistance to wear, with the proximal component resulting in a wear rate of 0.09mg/million cycles, whilst that of the distal component was 0.07mg/million cycles. Particle analysis revealed that the majority of debris generated during the wearing in phase (0.5 million cycles) was <0.5μm in diameter. During the steady state phase (0.5–3 million cycles) a large peak in particle size was observed in the 2μm diameter range, whilst in the latter stage (3–5 million cycles) peaks in particle size were seen at 0.4μm and 2μm. During each stage, both the particle count and aspect ratio remained relatively unchanged. Conclusion. Under these test conditions the CFR-PEEK coupling demonstrated a linear and consistently low wear rate over the 5 million cycle test period, with the majority of particles generated being <2μm in diameter. The low wear rate and biocompatibility demonstrated by CFR-PEEK suggests it is a suitable alternative to silicone in PIP joint prostheses. Acknowledgements. The authors would like to thank Zrinski AG, Christian Kaddick at EndoLab GmbH for the wear simulator work and Mark Yeoman at Continuum Blue Ltd. for particle analysis

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

Introduction. Minimally invasive implanted unicompartmental knee arthroplasty (UKA) leads to excellent functional results. Due to the reduced intraoperative visibility it is difficult to remove extruded bone cement particles, as well as bone particles generated through the sawing. These loose third body particles are frequently found in minimally invasive implanted UKA. The aim of this study was to analyse the influence of bone and cement particles on the wear rate of unicompartmental knee prostheses in vitro. Material & Methods. Fixed- bearing unicompartmental knee prostheses (n = 3; Univation F®, Aesculap, Tuttlingen) were tested with a customized four-station servo-hydraulic knee wear simulator (EndoLab GmbH, Thansau, Germany) reproducing exactly the walking cycle as specified in ISO 14243-1:2002. After 5.0 million cycles crushed cortical bone chips were added to the test fluid for 1.5 million cycles to simulate bone particles, followed by 1.5 million cycles blended with PMMA- particles (concentration of the third-body particles: 5g/l; particle diameter: 0.5- 0.7 mm). Every 500 000 cycles the volumetric wear rate was measured (ISO 14243-2) and the knee kinematics were recorded. For the interpretation of the test results we considered four different phases: breaking in- (during the first 2.0 million cycles), the steady state- (from 2.0 million to 5 million cycles), bone particle- and cement particle phase. Finally, a statistical analysis was carried out to verify the normal distribution (Kolmogorov-Smirnov test), followed by direct comparisons to differentiate the volumetric wear amount between the gliding surfaces (paired Student's t-test, p<0.05). Results. The wear rate was 12.5±0.99 mm. 3. /mio. cycles in the breaking-in phase and decreased during the steady state phase to 4.4±0.91 mm. 3. /mio cycles (not significant, p = 0,3). The bone particles did not have any influence on the wear rate (3.0±1.27 mm. 3. /mio cycles; p = 0,83) compared to the steady state phase. The cement particles, however, lead to a significantly higher wear rate compared to the steady state phase (25.0±16.93 mm. 3. /mio cycles; p<0.05). Discussion. To our knowledge this is the first study demonstrating that free cement debris which can be found after minimally invasive implanted UKA increases significantly the wear- rate. Bone particles generated for instance through sawing during implantation, however, had no influence on the prostheses wear rate. Our Data suggests, that it is extremely important to remove all the extruded cement debris accurately during implantation in order to avoid a higher wear rate which could result in an early loosening of the prostheses

Periprosthetic osteolysis depends on the biological activity of wear particles, but there is little known about the distribution of polyethylene wear particles (PE) in the surrounding joint tissue. The purpose of this study was to examine the localisation of wear particles of six different PEs, including four crosslinked polyethylenes (XPE), as well as their biological activity in the murine knee. Material and Methods. Wear particles of 4 XPE- and 2 UHMWPE-inserts were isolated (knee joint simulator). For all groups the particles were similar in size and shape (mean diameter 0.3–05μm; 20nm-nucleopore-filter; ISO; n = 100.000).56 female Balb/c mice were randomly assigned to six treatment groups and one control group: control (PBS), XPE1 (3×30 kGy Gamma, annealed/sequential irradiated), XPE2 (95 kGy E-beam, remelted), XPE3 (65 kGy E-beam, remelted), XPE 4 (50 kGy Gamma, remelted), UHMWPE 1, UHMWPE 2. 50 μl of each particle suspension [(0.1% vol/vol (particle volume/PBS volume) after removal of endotoxin] were injected into the left knee joint. After 1 week the mice were killed and a histological and immunhistochemical analysis of the knee joints was done (IL-1, TNF-, ICAM-1). For the immunhistochemistry the articular cartilage, the bone marrow and the synovial membrane were evaluated semiquantitatively (Kruskal-Wallis test; all pairwise multiple comparison procedure; Bonferoni correction; significance level: p<0.05). Results. All groups showed a thickened synovial layer with an increased cellular infiltration. The particles of XPE 1 and 2 were localised in the bone marrow as well as in the joint space. In contrast, the particles of XPE 3 and 4 were distributed in the synovial layer and in the bone marrow as well, but not in the joint space. The UHMWPE1 particles were mainly located in the bone marrow and joint space while the UHMWPE2 particles were mainly found in the bone marrow and the synovial layer. For all PE groups there was a higher cytokine expression compaired to control (p<0.0024) without any differences between the groups (bone marrow/synovial layer). The chondrocytes in the groups with XPE 1- and XPE 2-particles expressed more TNF- than in the control group and the other treatment groups (p = 0.000). Conclusion. XPEs lead to a similar inflammatory reaction in vivo compared to conventional polyethylenes. The high TNF- expression in the articular cartilage (groups XPE 1 and 2) might be explained by the localisation of the wear particles in the joint space in direct contact with the chondrocytes. Long-term studies are necessary to analyse the effects of different wear particle distributions in the joint surrounding tissue after knee and hip replacement. Furthermore it has to be investigated, whether their distribution in the joint space or their transport into the bone marrow is responsible for the level of the chronic inflammatory reaction

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

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

Introduction. Infection of endoprostheses is a serious complication in orthopedic surgery. As silver is known for its antibactierial effects, silver-coated endoprostheses have gained increased attention to decrease infection rates. However, cytotoxic effects of silver on bone cells have not been investigated in detail. We aimed to investigate whether silver nano-/microparticles and ionic silver exert cytotoxic effects on osteoblasts and osteoclasts in vitro and to correlate potential effects with the antibacterial effect on Staph. epidermidis. Methods. Murine osteoclasts (OC) and murine osteoblasts (OB) were treated with silver particles (avg. sizes: 50nm, 3μm, 30μm, 8μg/ml–500μg/ml) and Ag+NO3- (0.5μg/ml–500μg/ml). Silver treatment started on day 3 to prevent interference with cell adhesion. XTT assays were performed to assess cell viability. Tartrate resistant acidic phosphatase (TRAP) activity and alkaline phosphatase (ALP) activity served as measures for OC and OB differentiation, respectively. The release of silver ions from silver particles was quantified with atomic emission spectometry (AES). Titanium particles (avg. sizes: 50nm and 30μm) were used as controls to investigate whether potential silver effects were particle- or ion-mediated. The antimicrobial activity of silver ions and particles was tested with Staph. epidermidis agar inhibition assays. Results. Ionic silver had the strongest impact on cell differentiation and viability of OC and OB (OC differentiation: mean IC50 = 5 μg/ml, OC viability: mean IC50 = 14 μg/ml, OB differentiation: mean IC50 = 1 μg/ml, OB viability: mean IC50 = 1 μg/ml). Silver nanoparticles decreased cell differentiation and viability in a dose dependent manner (OC differentiation: mean IC50 = 5μg/ml, OC viability: mean IC50 = 14μg/ml, OB differentiation: mean IC50 = 1μg/ml, OB viability: mean IC50 = 1μg/ml). Silver microparticles as well as titanium nano- and microparticles had no effect on cell differentiation and viability. AES showed a size and dose dependent release of silver ions from silver nano- and microparticles. Agar inhibition assays showed a dose correlation of the antibacterial effect of silver with the cytotoxic effects on OB and OC. Conclusion. Silver nanoparticles and silver ions exert dose-dependent cytotoxic effects on OB and OC in vitro resulting in a severe alteration of cell differentiation and viability. The effect of silver on OB and OC seems to be mediated primarily by silver ions and correlates with the substance's antibacterial effects. The cytotoxicity of silver nanoparticles is mediated primarily by the size-dependent liberation of silver ions. Disturbance of OB and OC survival may have deleterious effects on the osseointegration of orthopedic implants. Further in vivo studies are needed to investigate the osseointegration of silver coated implants prior to their widespread clinical application

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

INTRODUCTION. The lifetime of UHMWPE implants may be limited by wear and oxidative degeneration. Wear produced particles are in general biologically active, and may induce osteolysis. As threshold of PE wear rate below which osteolysis is rarely observed is postulated to be less tahn 0.1 mm per year. Moreover, PE delamination and breakage are consequences of the embrittlement of the PE due to oxidation. Both demonstrate, that improving the clinical behaviour of UHMWPE means reduction of wear particles. The first can be achieved by cross-linking the second by the anti-oxidative stabiliser vitamin E. The highly cross-linked PE vitamys ® used for the isoelastic monobloc cup RM Pressfit (Mathys AG Bettlach, Bettlach, Switzerland) is mixed with 0.1% of synthetic vitamin E and is the first and only highly cross-linked PE used in total hip replacement that meets all requirements for the best grade UHMWPE in yield strength, ultimate tensile strength and elongation at break. METHODS AND MATERIAL. With the first implantation of RM Pressfit vitamys® a prospective multicentre study was started. So far 256 cases in 7 clinics from Europe and New Zealand are included. This report presents the first clinical experiences of one Swiss clinic from the multicentre study. Prospective data collection includes Harris Hip score (HHS), patient satisfaction and radiographic analysis. Clinical and radiographic follow-up is done after 6 weeks, 6, 12 and 24 months, and thereafter for long-term results. Standardized documentation of surgery and postoperative course is performed. RESULTS. 81 patients were included in the study. Mean age at implantation is 69 years. The indication was primary OA in 57% and secondary OA in 36%, the others were treated either for necrosis, fracture or hip dysplasia. 68% of the patients received a 36mm femoral head, 31% a 32mm and 1% a 28mm. Intraoperatively two minor complications occurred, one femur and one trochanter fissure. No complications occurred during implantation of the cup. Most of the cups (59%) were implanted with an inclination of 40°-50°, 30% with 35°-40°. There were no signs of early loosening and a good Harris Hip Score was achieved. DISCUSSION. The principals of this monobloc cup with its isoelastic property and the thin titanium coating is a proven concept. Ihle et al. (JBJS 2008) reported 91% survival rate with revision for aseptic loosening as endpoint after 20 years. They found an increase of cup revisions after 14 to 16 years after implantation due to osteolysis probably due to PE wear. At short term, we haven't encountered any problems related to the implantation of this cup. So far one patient in the entire multicentre study needed a stem revision after periprosthetic femur fracture. To prove the durability of this novel material a follow-up of 14 years and more will be required

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

Background. An increasing number of hip prostheses are inserted without bone cement. Experimental research has shown that hydroxyapatite (HA) coated implants are strongly fixated in the bone, which is believed to reduce the likelihood of prosthetic loosening. However, in recent years, there has been much debate about the role of HA particles in third-body polyethylene (PE) wear and formerly we have shown the revision rate to be high among older-design HA coated cups. Purpose. We hypothesized increased PE wear-rate using HA coated acetabular components in comparison with non-HA coated components (control group). Materials and Methods. We performed a retrospective comparative clinical study based on two patient populations identified in the Danish Hip Arthroplasty Registry (October 2006). All patients had primary total hip arthroplasty (THA) between 1997 and 2001 with cementless Mallory-Head acetabular components. One group received HA coated acetabular components (75 patients, 77 hips). The other group received identical components without HA (70 patients, 73 hips). In all cases the liner was similar and 28 mm metal femoral heads were used. All patients were invited for a radiographic follow-up in 2007. The AP radiographs were analysed for two-dimensional (2D) polyethylene wear using the semi-automated PolyWare software. All cases of non-responders, stem revisions, hip dislocations and patients with less than 5 years of follow-up were excluded from the analysis. Findings/Results. The 2D linear PE wear-rate of 0.18 mm/year (SD 0.09) was higher (P<0.001) in the group with HA coated cups (n = 54) compared with 0.12 mm/year (SD 0.07) in the group of non-HA coated cups (n = 35). The Effect size of the difference in linear PE wear-rate, established as Cohen's d, was large (0.9). The time of follow-up was similar (p = 0.11) in the HA group (7.2 years) versus the non-HA group (7.6 years). There was no case-mix concerning distribution of gender and operated side in the groups; however, the mean age was lower (P = 0.001) in the HA group (57 years) compared with the non-HA group (63 years). Conclusions. We found a significantly increased PE wear rate in HA coated acetabular components at midterm follow-up. The patients with HA coated cups were younger on average, and this might partly explain the findings because the activity level expectedly is higher in younger patients. Still an effect size of 0.9 is large and should raise concern and supplement considerations in future clinical decisions on component selection. A randomized (RSA) study on newer type crosslinked polyethylene liners is recommended to bring about more information on the clinical performance and longevity of HA coated acetabular components

INTRODUCTION. Cementless Total Hip Replacement surgery is a well established procedure for relative young patients with severe hip disease. Excellent long term clinical results have been published on the performance of the femoral component. With growing clinical experience, our concern focused on excessive wear of the Ultra High Molecular Weight Polyethylene (UHMWPE) ringloc liner of the Mallory Head cementless Total Hip Prosthesis. After its introduction in our clinic in 1997, this implant is still in use without any modification. We were concerned that due to premature liner wear, the performance of this implant would not be compliant with the international guideline on implant survival (NICE guidelines: at 10 year follow up, 90% of all implants should still be in situ). Our objective was to establish the amount of liner wear in our first 200 MH implants. METHODS. Our first 200 patients consecutively treated with Mallory Head prostheses were followed up to obtain a recent digital image. Follow up was complete for 181 (90.5%) of our 200 patients. Ten had died and nine were not able or willing to come for follow up. The mean duration of follow up was 8.3 years (range: 8–13). The 181 recent digital images were classified as either excessive wear or no excessive wear by two independent orthopedic surgeons. Next, liner wear was measured in the 2D frontal plane using PolyWare Pro/3D Digital Version Rev 5.1 software (Draftware Developers, Conway, USA). A threshold for excessive liner wear was set at 0.2mm/year, according to literature. RESULTS. Using software for measuring PE wear, 46.7% of all patients had excessive UHMWPE wear (> 0.2mm/yr). There was no relation between the amount of wear and BMI, gender, component size or the acetabular inclination angle. Thirteen patients (6.5%) were revised. Nine of these revisions were for excessive liner wear or aseptic loosening (4.5%). For now, our series of cementless Mallory Head prostheses is compliant with the NICE guideline on implant survival. However, with the measured amount of wear we expect to see a significant increase in the number of revisions for liner wear in the near future. DISCUSSION. Our clinical observation of premature UHMWPE wear proved correct. The measured amount of UHMWPE wear is consistent with the few other studies published on this subject. Although we present a retrospective study, limiting the strength of our results, we have included a large group of patients with acceptable loss to follow up. It is unclear if the observed wear will lead to a sharp increase in the number of revisions within the next few years. Possibly, future revisions will be complicated by loss of acetabular bone stock following the pathofysiological reaction to wear particles. Our results can probably be generalised for any district hospital

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

INTRODUCTION. Femoral neck narrowing (NN) following Metal-on-Metal Hip Resurfacing Arthroplasty (MoMHRA) is a well-recognised clinical phenomenon. The incidence of resurfaced hips with NN > 10% is reported to be up to 27%. Its pathogenesis is thought to be multi-factorial secondary to stress shielding, impingement, osteolysis secondary to wear/ion particles and as a result of reduced vascularity and pressure effect on cancellous bone secondary to the presence of a soft-tissue mass around the resurfaced hip. Recognised risk factors for its development include: female gender and the presence of a pseudotumour. Serum Chromium (Cr) and Cobalt (Co) are recognised surrogate markers of in-vivo wear of MoMHRA. The aims of this study were to establish whether NN is associated with increased wear. METHODS. A cohort of 214 patients with unilateral MoMHRA (139M: 75F) was included in this study. Primary osteoarthritis was the diagnosis leading to surgery for the majority of patients (208). The average age at surgery was 54.1 years old (13–73). Six different implants were used; BHR (116), Conserve plus (92), Recap (2), ASR (2), Adept (1) and Cormet (1). The average femoral component size was 49.2mm (range: 38–59). The average follow up was 4.3 years (range: 2–10). Patients were subdivided into 3 groups as per implant size. Small size component group had implants <45mm, average size group had components 45–51mm and large component size group had components >51mm. All patients had Prosthesis-Junction-Ratio (PJR) measured from postoperative (PJRpost) and at latest follow up (PJRfollow) radiographs. Measurements were made using the method described by Lilikakis1. Metal ion levels (Cr/Co) were measured at last follow-up for all patients. Cr level >5.1g/ml and Co levels >4.4 g/ml were considered high2 and patients with such levels formed the high ion group. RESULTS. For the whole cohort, mean NN was 3.2% (range: 0–32%, SD:4.3). Females (4.7%, range: 0–32%, SD: 5.8) had significantly greater NN than males (2.4%, range: 0–23%, SD: 2.9) (p=0.001). Patients in the large component group had less NN (2.1%, SD: 2.3) in comparison to the average (3.2%, SD: 3.7%) (p=0.046) and the small (5.9%, SD: 7.9) (p=0.007) component size groups. There was no difference in NN between small and average sized components (p=0.1). Patients in the high ion group (25 patients) had significantly greater NN than patients with low ions (10.1%, range: 1%–32%, SD: 8.3 Vs 2.3%, range: 0–11, SD 2.3) (p<0.0001). NN >10% was seen in 16 hips (7.5%). The odds ratio of having high ions if NN >10% was 125 (p<0.001). DISCUSSION. The findings of this study showed that greater NN occurs in females and patients with small components and in patients with high ions. Furthermore, hips with NN >10% should be investigated further as they are more likely to have increased wear

Introduction. Large wear rate reductions have been shown for crosslinked PE in simulators and short- to mid-term clinical wear studies. However, concerns persist about long-term in-vivo oxidation (especially with annealed PE), late accelerating wear and the possibly higher osteolytic potential of crosslinked PE particle debris. This is the first long-term study comparing conventional to crosslinked PE investigating whether the wear reduction is maintained in the long-term and if reduced osteolysis becomes evident. Materials & Methods. In a prospective study 48 primary THA patients (Stryker ABG-II, 28mm CoCr heads) were randomized to either receive a first generation crosslinked PE (Stryker Duration: 3MRad gamma irradiation in N2, annealed) or then conventional, now “historic” PE (3MRad gamma irradiation in air). Both groups were statistically non-different (p>0.1) regarding age (63.9 years), gender, BMI, stem and cup size, cup inclination, liner thickness or pre- and post-op HHS leaving the insert material as the only variable. Patients were followed-up annually using the Harris Hip score, AP and lateral radiographs and digital wear measurements using Roman V1.70 [1, 2]. Wear and radiographic signs of osteolysis were analysed at a mean follow-up of 12.9 years (12.0–13.3). Groups were compared using the t-test (means) or the Fisher Exact test (proportions). Results. Thirty-one patients (18 conventional, 13 Duration) were left for analysis (8 deaths, 9 lost to FU). At 13yrs the total linear head penetration was sign. lower with Duration (0.70 ±0.36mm, range: 0.3–1.2mm) than conventional PE (1.56 ±0.83, range: 0.4–3.3mm, p=0.015). Also the annual wear rate was sign. lower (p=0.005) for Duration (0.063 ±0.027mm/yr) than conventional PE (0.122 ±0.065mm/yr). This reduction (−48%) compared well to the original simulator prediction (−45%) and even increased with time (−30% at 5yrs, −38% at 8yrs, −42% at 10yrs). In the Duration group only 1 patient had a wear rate >0.1mm/yr (osteolysis threshold) compared to 10 in the Conventional group (p=0.007). Patients with radiographic signs of acetabular osteolysis (cysts) on the AP x-ray were less frequent in the Duration (4/13=31%) than in conventional group (13/18=72%, p=0.023). This difference became even more pronounced when also the lateral view was evaluated and the affected DeLee-Charnley zones were counted (7 vs 22, p=0.017). Only in the conventional group a revision was performed (cup for wear). Discussion & Conclusions. At long-term FU the absolute wear rate of Duration crosslinked PE did not increase but decrease and the wear relative reduction did not deteriorate but increased. The incidence of osteolysis was sign. less. Thus No clinical evidence of degradation or elevated osteolytic potential for this annealed first generation crosslinked PE debris was found

Aims

Demineralised bone matrix (DBM) is rarely used for the local delivery of prophylactic antibiotics. Our aim, in this study, was to show that a graft with a bioactive glass and DBM combination, which is currently available for clinical use, can be loaded with tobramycin and release levels of antibiotic greater than the minimum inhibitory concentration for Staphylococcus aureus without interfering with the bone healing properties of the graft, thus protecting the graft and surrounding tissues from infection.

Objectives

Bisphosphonates are widely used as first-line treatment for primary and secondary prevention of fragility fractures. Whilst they have proved effective in this role, there is growing concern over their long-term use, with much evidence linking bisphosphonate-related suppression of bone remodelling to an increased risk of atypical subtrochanteric fractures of the femur (AFFs). The objective of this article is to review this evidence, while presenting the current available strategies for the management of AFFs.