Polyethylene Wear Testing of a Non-Mechanically Linked Total Elbow Replacement.

BACKGROUND: The objective of this study was to perform a polyethylene wear test on a non-mechanically linked total elbow arthroplasty implant using a clinically relevant in-vitro elbow wear test methodology that simulated ten years of use in the light to moderate activity of daily living range. MATERIALS AND METHODS: The test protocol applied an 80° arc of ulnohumeral motion beginning at 30° shy of full extension and progressing to 110° of flexion. Force was applied at 7° to recreate a valgus load on the elbow. A variable joint load profile at a frequency of 0.5 Hz was employed. The implants were tested for 5 million cycles (Mc) in a bovine serum lubricant. Implant component failure was characterized and polyethylene wear was determined gravimetrically. RESULTS: After 5 Mc the small polyethylene bushing wear rate was 0.56 mg/Mc. The medium size wear rate was 0.28 mg/Mc. Three large sizes were tested and the average wear rate was 0.39 ± 0.07 mg/Mc. No implant failure was identified. CONCLUSION: The test recreated an in vivo loading environment and measured polyethylene wear rates at specified cycle counts. The test demonstrated less wear than other joint replacements. Further clinical evaluation is necessary to determine if this translates into reduced complications of total elbow replacement associated with wear.

Numerical Analysis for Appropriate Positioning of Ferrous Wear Debris Sensors with Permanent Magnet in Gearbox Systems.

In order to improve the measurement sensitivity of ferrous wear debris sensors with a permanent magnet, a new numerical approach to the appropriate position of the sensor is presented. Moreover, a flow guide wall is proposed as a way to concentrate flow around the ferrous particle sensors. The flow guide wall is intended to further improve measurement sensitivity by allowing the flow containing ferrous particles to flow around the sensor. Numerical analysis was performed using the multi-physics analysis method for the most representative gearbox of the sump-tank type. In condition diagnosis using ferrous wear debris sensors, the position of the sensor has a great influence. In other words, there are cases where no measurements occur, despite the presence of abnormal wear and damage due to the wrong sensor position. To determine the optimal sensor position, this study used flow analysis for the flow caused by the movement of the gear, electric and magnetic field analysis to implement the sensor, and a particle tracing technique to track particle trajectory. The new analysis method and results of this study will provide important information for selecting the optimal sensor location and for the effective application of ferrous wear debris sensors, and will contribute to the oil sensor-based condition diagnosis technology.

A review of wear debris in thumb base joint implants.

AIM: Polymers and metals, such as polyethylene (PE) and cobalt chrome (CoCr), are common materials used in thumb-based joint implants, also known as CMC (Carpometacarpal) arthroplasty. The purpose of this review was to investigate the reported failure modes related to wear debris from these type of materials in CMC implants. The impact of wear debris on clinical outcomes of CMC implants was also examined. Potential adverse wear conditions and inflammatory particle characteristics were also considered. METHOD: A literature search was performed using PRISMA guidelines and 55 studies were reviewed including 49 cohort studies and 6 case studies. Of the 55 studies, 38/55 (69%) focused on metal-on-polyethylene devices, followed by metal-on-metal (35%), and metal-on-bone (4%). RESULTS: The summarized data was used to determine the frequency of failure modes potentially related to wear debris from metals and/or polymers. The most commonly reported incidents potentially relating to debris were implant loosening (7.1%), osteolysis (1.2%) and metallosis (0.6%). Interestingly the reported mechanisms behind osteolysis and loosening greatly varied. Inflammatory reactions, while rare, were generally attributed to metallic debris from metal-on-metal devices. Mechanisms of adverse wear conditions included implant malpositioning, over-tensioning, high loading for active patients, third-body debris, and polyethylene wear-through. No specific examination of debris particle characterization was found, pointing to a gap in the literature. CONCLUSION: This review underscores the types of failure modes associated with wear debris in CMC implants. It was found that failure rates and adverse wear conditions of CMC implants of any design are low and the exact relationship between wear debris and implant incidences, such as osteolysis and loosening remains uncertain. The authors note that further research and specific characterization is required to understand the relationship between debris and implant failure.

Ceramic Wear Particles: Can They Be Retrieved In Vivo and Duplicated In Vitro?

BACKGROUND: Little is known about retrieved zirconia platelet toughened alumina (ZPTA) wear particles from ceramic-on-ceramic (COC) total hip arthroplasty. Our objectives were to evaluate clinically retrieved wear particles from explanted periprosthetic hip tissues and to analyze the characteristics of in vitro-generated ZPTA wear particles. METHODS: Periprosthetic tissue and explants were received for 3 patients who underwent a total hip replacement of ZPTA COC head and liner. Wear particles were isolated and characterized via scanning electron microscopy and energy dispersive spectroscopy. The ZPTA and control (highly cross-linked polyethylene and cobalt chromium alloy) were then generated in vitro using a hip simulator and pin-on-disc testing, respectively. Particles were assessed in accordance with American Society for Testing and Materials F1877. RESULTS: Minimal ceramic particles were identified in the retrieved tissue, consistent with the retrieved components demonstrating minimal abrasive wear with material transfer. Average particle diameter from in vitro studies was 292 nm for ZPTA, 190 nm for highly cross-linked polyethylene, and 201 nm for cobalt chromium alloy. CONCLUSION: The minimal number of in vivo ZPTA wear particles observed is consistent with the successful tribological history of COC total hip arthroplasties. Due to the relatively few ceramic particles located in the retrieved tissue, in part due to implantation times of 3 to 6 years, a statistical comparison was unable to be made between the in vivo particles and the in vitro-generated ZPTA particles. However, the study provided further insight into the size and morphological characteristics of ZPTA particles generated from clinically relevant in vitro test setups.

Correlative Method for Diagnosing Gas-Turbine Tribological Systems.

Lubricated tribosystems such as main-shaft bearings in gas turbines have been successfully diagnosed by oil sampling for many years. In practice, the interpretation of wear debris analysis results can pose a challenge due to the intricate structure of power transmission systems and the varying degrees of sensitivity among test methods. In this work, oil samples acquired from the fleet of M601T turboprop engines were tested with optical emission spectrometry and analyzed with a correlative model. Customized alarm limits were determined for iron by binning aluminum and zinc concentration into four levels. Two-way analysis of variance (ANOVA) with interaction analysis and post hoc tests was carried out to study the impact of aluminum and zinc concentration on iron concentration. A strong correlation between iron and aluminum, as well as a weaker but still statistically significant correlation between iron and zinc, was observed. When the model was applied to evaluate a selected engine, deviations of iron concentration from the established limits indicated accelerated wear long before the occurrence of critical damage. Thanks to ANOVA, the assessment of engine health was based on a statistically proven correlation between the values of the dependent variable and the classifying factors.

CoNiCrMo Particles, but Not TiAlV Particles, Activate the NLRP3 Inflammasome in Periprosthetic Cells.

Aseptic loosening is the main reason for arthroplasty failure. The wear particles generated at the tribological bearings are thought to induce an inflammatory tissue response, leading to bone loss and the subsequent loosening of the implant. Different wear particles have been shown to activate the inflammasome, thereby contributing to an inflammatory milieu in the direct vicinity of the implant. The aim of this study was to investigate whether the NLRP3 inflammasome is activated by different metal particles in vitro and in vivo. Three different cell lines representing periprosthetic cell subsets (MM6, MG63 and Jurkat) were incubated with different amounts of TiAlV or CoNiCrMo particles. The activation of the NLRP3 inflammasome was determined through the detection of the caspase 1 cleavage product p20 in a Western blot. The formation of the inflammasome was also investigated in vivo using immunohistological staining for ASC in primary synovial tissues as well as tissues containing TiAlV and CoCrMo particles and in vitro after the stimulation of the cells. The results show that the CoCrMo particles induced ASC more markedly, as a readout for inflammasome formation in vivo, compared to TiAlV particular wear. The CoNiCrMo particles also induced ASC-speck formation in all the tested cell lines, which was not induced by the TiAlV particles. The Western blot shows that NRLP3 inflammasome activation, measured through caspase 1 cleavage, was increased only by the CoNiCrMo particles in the MG63 cells. We conclude from our data that the activation of the inflammasome is mainly driven by CoNiCrMo particles and less by TiAlV particles, indicating that different inflammatory pathways are activated by the different alloys.

Osteocytic cells exposed to titanium particles increase sclerostin expression and inhibit osteoblastic cell differentiation mostly via direct cell-to-cell contact.

The mechanism underlying induction of periprosthetic osteolysis by wear particles remains unclear. In this study, cultured MLO-Y4 osteocytic cells were exposed to different concentrations of titanium (Ti) particles. The results showed that Ti particles increased expression of the osteocytic marker SOST/sclerostin in a dose-dependent manner, accelerated apoptosis of MLO-Y4 cells, increased the expression of IL-6, TNF-α and connexin 43. SOST silence alleviated the increase of MLO-Y4 cells apoptosis, decreased the expression of IL-6, TNF-α and connexin 43 caused by Ti particles. The different co-culture systems of MLO-Y4 cells with MC3T3-E1 osteoblastic cells were further used to observe the effects of osteocytic cells' changes induced by Ti particles on osteoblastic cells. MLO-Y4 cells treated with Ti particles inhibited dramatically differentiation of MC3T3-E1 cells mostly through direct cell-to-cell contact. SOST silence attenuated the inhibition effects of Ti-induced MLO-Y4 on MC3T3-E1 osteoblastic differentiation, which ALP level and mineralization of MC3T3-E1 cells increased and the expression of ALP, OCN and Runx2 increased compared to the Ti-treated group. Taken together, Ti particles had negative effects on MLO-Y4 cells and the impact of Ti particles on osteocytic cells was extensive, which may further inhibit osteoblastic differentiation mostly through intercellular contact directly. SOST/sclerostin plays an important role in the process of mutual cell interaction. These findings may help to understand the effect of osteocytes in wear particle-induced osteolysis.

A comparison of the inflammatory host response to particulate debris adjacent to unlocked and locked screws of a growth guidance system for early onset scoliosis.

PURPOSE: The SHILLA™ Growth Guidance system is a stainless-steel rod and screw system used for Early Onset Scoliosis which incorporates a unique flanged set screw designed to capture the rod, while allowing it to slide as the patient grows. Concomitant with this design is the potential for generation of wear debris and for an inflammatory host response. We hypothesized that the magnitude of the host response adjacent to the unlocked screws and rods would be greater than the host response to the locked rod/screws. METHODS: Seven tissue samples adjacent to locked (3) and unlocked screws (4) from three SHILLA patients (mean implantation time of 19 post-operative months) with infantile idiopathic scoliosis were obtained as part of an explant analysis protocol during a PMDA-approved clinical trial in Japan. Gross appearance, high-resolution radiographs, and histology were assessed. ISO Standard 10993 Part 6 was used to assess the host response. RESULTS: All three locked screw had no metallosis. In contrast, metallosis for unlocked screw tissue samples were rated as "ubiquitous" (2/4), "focal" (1/4), or "absent" (1/4). Microscopic metallic debris was found intracellularly and within interstices of fibrous connective tissues more frequently adjacent to unlocked screws compared to locked screws. Cell type and population scoring consistently showed a modestly larger inflammatory response (macrophages) in the unlocked tissue samples. CONCLUSIONS: The peri-prosthetic tissue response to the unlocked rods/screws had a higher reactivity grade (slight reaction, Δ = 4.0) per ISO 10993 Part 6 compared to the locked screws in three patients with the SHILLA™ Growth Guidance scoliosis system.

A Novel Method for Detecting Ferromagnetic Wear Debris with High Flow Velocity.

Inductance detection is an important method for detecting wear debris in ship lubricating oil. Presently, an LCR (inductance, resistance, capacitance) meter is generally used to detect wear debris by measuring the inductance change of the sensing coil. When ferromagnetic debris passes through the sensing coil, a pulse will appear in the inductance signal. Previous studies have shown that the amplitude of the inductance pulse decreases significantly with the increase in the particles' velocity. Therefore, it is difficult to detect ferromagnetic debris with a high flow velocity using an LCR meter. In this paper, a novel method, high-frequency voltage acquisition (HFVA), is proposed to detect ferromagnetic debris. Different from previous methods, the wear debris was detected directly by measuring the voltage change of the sensing coil, while the synchronized sampling method was utilized to ensure the higher-frequency acquisition of the sensor output signal. The experimental results show that when the velocity of particles increased from 6 mm/s to 62 mm/s, the amplitude of the signal pulse obtained by HFVA decreased by only 13%, which was much lower than the 85% obtained by utilizing the LCR method.

A New In Situ Coaxial Capacitive Sensor Network for Debris Monitoring of Lubricating Oil.

Wear debris monitoring of lubricant oil is an important method to determine the health and failure mode of key components such as bearings and gears in rotatory machines. The permittivity of lubricant oil can be changed when the wear debris enters the oil. Capacitive sensing methods showed potential in monitoring debris in lubricant due to the simple structure and good response. In order to improve the detection sensitivity and reliability, this study proposes a new coaxial capacitive sensor network featured with parallel curved electrodes and non-parallel plane electrodes. As a kind of through-flow sensor, the proposed capacitive sensor network can be in situ integrated into the oil pipeline. The theoretical models of sensing mechanisms were established to figure out the relationship between the two types of capacitive sensors in the sensor network. The intensity distributions of the electric field in the coaxial capacitive sensor network are simulated to verify the theoretical analysis, and the effects of different debris sizes and debris numbers on the capacitance values were also simulated. Finally, the theoretical model and simulation results were experimentally validated to verify the feasibility of the proposed sensor network.