Surface and form alterations in retrieved shoulder hemiarthroplasty.

BACKGROUND: Shoulder hemiarthroplasty is a viable treatment for shoulder arthritis, particularly if the natural glenoid is still intact. One of the most common reasons for revision surgery is glenoid erosion, where the cartilage or bone is worn. The aim of the current study was to analyze whether the metallic articular surface of retrieved shoulder hemiarthroplasty is different from new implants. We hypothesized that the surface roughness would increase as a result of the articulation and that metallic wear would be detectable on the implants. METHODS: Included were 13 retrieved and 3 new shoulder hemiarthroplasties. The surface roughness was measured on different sites of the surface (dome of the head and the rim). The implants were further measured using a coordinate measuring machine to gain information on volumetric wear and geometric alterations. The surface was analyzed with a scanning electron microscope to see marks of wear. RESULTS: Compared with new implants, the surface roughness on the retrievals was significantly increased. The roughness parameters within the retrieval group were generally higher at the dome of the head than at the rim; however, this difference was not significant. Apart from shape deviations caused by deformation of the retrievals, no volumetric wear was detectable on the heads. CONCLUSIONS: The current results indicate that the roughness of the surface of the implant and the shape changes occur in vivo and that the material incurs damaged caused by the articulation against the softer cartilage or bone. Increasing roughness of the humeral component may be one cause for glenoid erosion over time.

On the inflammatory response in metal-on-metal implants.

BACKGROUND: Metal-on-metal implants are a special form of hip endoprostheses that despite many advantages can entail serious complications due to release of wear particles from the implanted material. Metal wear particles presumably activate local host defence mechanisms, which causes a persistent inflammatory response with destruction of bone followed by a loosening of the implant. To better characterize this inflammatory response and to link inflammation to bone degradation, the local generation of proinflammatory and osteoclast-inducing cytokines was analysed, as was systemic T cell activation. METHODS: By quantitative RT-PCR, gene expression of cytokines and markers for T lymphocytes, monocytes/macrophages and osteoclasts, respectively, was analysed in tissue samples obtained intraoperatively during exchange surgery of the loosened implant. Peripheral T cells were characterized by cytofluorometry before surgery and 7 to 10 days thereafter. RESULTS: At sites of osteolysis, gene expression of cathepsin K, CD14 and CD3 was seen, indicating the generation of osteoclasts, and the presence of monocytes and of T cells, respectively. Also cytokines were highly expressed, including CXCL8, IL-1ß, CXCL2, MRP-14 and CXCL-10. The latter suggest T cell activation, a notion that could be confirmed by detecting a small, though conspicuous population of activated CD4+ cells in the peripheral blood T cells prior to surgery. CONCLUSION: Our data support the concept that metallosis is the result of a local inflammatory response, which according to histomorphology and the composition of the cellular infiltrate classifies as an acute phase of a chronic inflammatory disease. The proinflammatory environment, particularly the generation of the osteoclast-inducing cytokines CXCL8 and IL1-ß, promotes bone resorption. Loss of bone results in implant loosening, which then causes the major symptoms of metallosis, pain and reduced range of motion.

How do gait frequency and serum-replacement interval affect polyethylene wear in knee-wear simulator tests?

Polyethylene wear (PE) is known to be a limiting factor in total joint replacements. However, a standardized wear test (e.g. ISO standard) can only replicate the complex in vivo loading condition in a simplified form. In this study, two different parameters were analyzed: (a) Bovine serum, as a substitute for synovial fluid, is typically replaced every 500,000 cycles. However, a continuous regeneration takes place in vivo. How does serum-replacement interval affect the wear rate of total knee replacements? (b) Patients with an artificial joint show reduced gait frequencies compared to standardized testing. What is the influence of a reduced frequency? Three knee wear tests were run: (a) reference test (ISO), (b) testing with a shortened lubricant replacement interval, (c) testing with reduced frequency. The wear behavior was determined based on gravimetric measurements and wear particle analysis. The results showed that the reduced test frequency only had a small effect on wear behavior. Testing with 1 Hz frequency is therefore a valid method for wear testing. However, testing with a shortened replacement interval nearly doubled the wear rate. Wear particle analysis revealed only small differences in wear particle size between the different tests. Wear particles were not linearly released within one replacement interval. The ISO standard should be revised to address the marked effects of lubricant replacement interval on wear rate.

Influence of Accelerated Aging on the Wear Behavior of Cross-Linked Polyethylene Liners-A Hip Simulator Study.

Sequential cross-linked and annealed ultra-high-molecular-weight polyethylene (SX-PE) is known as a low-wear articulating partner, especially for total hip endoprostheses. Aging of polymeric materials, irrespective of if induced by shelf or in vivo life, can degrade their tribological and mechanical properties. However, changes in wear behavior of aged SX-PE liners have not been not quantified so far. An accelerated aging procedure, to simulate shelf and in vivo aging, was performed on thin SX-PE liners after five million load cycles using a simulator ("worn-aged") as well as on new SX-PE liners ("new-aged"). A subsequent hip simulator test was performed with both thin SX-PE liner sets in combination with large-diameter ceramic femoral head, representing a combination known as advantageous for treatment after revision because of dislocation. Oxidation indices were measured on the liners after each step of the procedure. SX-PE liners after accelerated aging show bedding-in phases during simulator test, which was a characteristic only known from clinical investigations. Hence, the wear rates of the "new-aged" ((1.71 ± 0.49) mg/million cycles) and of the "worn-aged" ((9.32 ± 0.09) mg/million cycles) SX-PE were increased in the first period compared to new unaged SX-PE liners. Subsequently, the wear rates decreased for "new-aged" and "worn-aged" inserts to (0.44 ± 0.48) mg/million cycles and (2.72 ± 0.05) mg/million cycles, respectively. In conclusion, the results show promising effects of accelerated aging on SX-PE liners in simulator testing and for potential long-term use in clinical applications.

Synovial fluid replication in knee wear testing: an investigation of the fluid volume.

Wear testing cannot replicate the variations in wear rates and wear mechanisms seen in vivo, which may be related to differences between in vivo and in vitro conditions. A considerable difference exists between the in vivo synovial fluid volume (few milliliter) and the in vitro substituted bovine serum volume (several hundred milliliter). The aim of this study was to analyze the effects of a reduced fluid volume on the wear behavior in a knee wear simulator study. Four wear tests with decreasing fluid volumes (250, 150, 75, and 45 ml) were carried out. Using a large fluid volume of 250 ml for wear testing resulted in a wear rate of 9.7±1.2 mm3/10(6) cycles. Decreasing the fluid volume consecutively reduced the wear rate to down to 8.8±1.4 mm3/10(6) for 150 ml (p=1.00), 5.6±1.2 mm3/10(6) for 75 ml (p=0.01), and 1.0±0.2 mm3/10(6) cycles for 45 ml fluid volume (p≤0.01). Additionally, higher serum degradation and larger wear particles were observed with smaller fluid volumes used for testing. This study demonstrates the high relevance of the protein-based lubricant on the wear behavior and the technical limitation to replicate the synovial fluid in simulator tests. Wear testing should be carried out using larger fluid volumes (e.g., 250 ml) to generate physiological relevant wear masses.

Fatigue performance of medical Ti6Al4V alloy after mechanical surface treatments.

Mechanical surface treatments have a long history in traditional engineering disciplines, such as the automotive or aerospace industries. Today, they are widely applied to metal components to increase the mechanical performance of these. However, their application in the medical field is rather rare. The present study aims to compare the potential of relevant mechanical surface treatments on the high cycle fatigue (R = 0.1 for a maximum of 10 million cycles) performance of a Ti6Al4V standard alloy for orthopedic, spinal, dental and trauma surgical implants: shot peening, deep rolling, ultrasonic shot peening and laser shock peening. Hour-glass shaped Ti6Al4V specimens were treated and analyzed with regard to the material's microstructure, microhardness, residual stress depth profiles and the mechanical behavior during fatigue testing. All treatments introduced substantial compressive residual stresses and exhibited considerable potential for increasing fatigue performance from 10% to 17.2% after laser shock peening compared to non-treated samples. It is assumed that final mechanical surface treatments may also increase fretting wear resistance in the modular connection of total hip and knee replacements.

Wear testing of moderate activities of daily living using in vivo measured knee joint loading.

Resumption of daily living activities is a basic expectation for patients provided with total knee replacements. However, there is a lack of knowledge regarding the impact of different activities on the wear performance. In this study the wear performance under application of different daily activities has been analyzed. In vivo load data for walking, walking downstairs/upstairs, sitting down/standing up, and cycling (50 W & 120 W) has been standardized for wear testing. Wear testing of each activity was carried out on a knee wear simulator. Additionally, ISO walking was tested for reasons of comparison. Wear was assessed gravimetrically and wear particles were analyzed. In vivo walking produced the highest overall wear rates, which were determined to be three times higher than ISO walking. Moderate wear rates were determined for walking upstairs and downstairs. Low wear rates were determined for standing up/sitting down and cycling at power levels of 50 W and 120 W. The largest wear particles were observed for cycling. Walking based on in vivo data has been shown to be the most wear-relevant activity. Highly demanding activities (stair climbing) produced considerably less wear. Taking into account the expected number of loads, low-impact activities like cycling may have a greater impact on articular wear than highly demanding activities.

Force-controlled dynamic wear testing of total ankle replacements.

Currently, our knowledge of wear performance in total ankle replacements is limited. The aim of this study is to develop a scenario for force-controlled testing and wear testing of total ankle replacements. A force-controlled wear test was developed: based on cadaver measurements, the passive stabilization (ligaments and soft tissue) of the ankle joint was characterized and a restraint model for ankle stabilization was developed. Kinematics and kinetics acting at the replaced ankle joint were defined based on literature data and gait analysis. Afterwards, force-controlled wear testing was carried out on a mobile, three-component, total ankle replacement design. Wear was assessed gravimetrically and wear particles were analyzed. Wear testing resulted in a mean wear rate of 18.2±1.4mm(3)/10(6) cycles. Wear particles showed a mean size of 0.23µm with an aspect ratio of 1.61±0.96 and a roundness of 0.62±0.14. Wear testing of total ankle replacement shows that a relevant wear mass is generated with wear particles in a biologically relevant size range. The developed wear test provides a basis for future wear testing of total ankle replacements.

Wear behavior of an unstable knee: stabilization via implant design?

BACKGROUND: Wear-related failures and instabilities are frequent failure mechanisms of total knee replacements. High-conforming designs may provide additional stability for the joint. This study analyzes the effects of a ligamentous insufficiency on the stability and the wear behavior of a high-conforming knee design. METHODS: Two simulator wear tests were performed on a high-conforming total knee replacement design. In the first, a ligamentous-stable knee replacement with a sacrificed anterior cruciate ligament was simulated. In the second, a ligamentous-unstable knee with additionally insufficient posterior cruciate ligament and medial collateral ligament was simulated. Wear was determined gravimetrically and wear particles were analyzed. Implant kinematics was recorded during simulation. RESULTS: Significantly higher wear rates (P ≤ 0.001) were observed for the unstable knee (14.58 ± 0.56 mg/10(6) cycles) compared to the stable knee (7.97 ± 0.87 mg/10(6) cycles). A higher number of wear particles with only small differences in wear particle characteristics were observed. Under unstable knee conditions, kinematics increased significantly for translations and rotations (P ≤ 0.01). This increase was mainly attributed to higher tibial posterior translation and internal rotations. CONCLUSION: Higher kinematics under unstable test conditions is a result of insufficient stabilization via implant design. Due to the higher kinematics, increased wear was observed in this study.

Hard-on-hard lubrication in the artificial hip under dynamic loading conditions.

The tribological performance of an artificial hip joint has a particularly strong influence on its success. The principle causes for failure are adverse short- and long-term reactions to wear debris and high frictional torque in the case of poor lubrication that may cause loosening of the implant. Therefore, using experimental and theoretical approaches models have been developed to evaluate lubrication under standardized conditions. A steady-state numerical model has been extended with dynamic experimental data for hard-on-hard bearings used in total hip replacements to verify the tribological relevance of the ISO 14242-1 gait cycle in comparison to experimental data from the Orthoload database and instrumented gait analysis for three additional loading conditions: normal walking, climbing stairs and descending stairs. Ceramic-on-ceramic bearing partners show superior lubrication potential compared to hard-on-hard bearings that work with at least one articulating metal component. Lubrication regimes during the investigated activities are shown to strongly depend on the kinematics and loading conditions. The outcome from the ISO gait is not fully confirmed by the normal walking data and more challenging conditions show evidence of inferior lubrication. These findings may help to explain the differences between the in vitro predictions using the ISO gait cycle and the clinical outcome of some hard-on-hard bearings, e.g., using metal-on-metal.

Characterization of polyethylene wear particle: The impact of methodology.

Due to the prevalence of problems caused by wear particles, the reduced durability of total joint replacements is well documented. The characterization of wear debris enables the size and morphology of these wear particles to be measured and provides an assessment of the biological response in vivo. However, the impact of different methodologies of particle analysis is not yet clear. Hence, the aim of this investigation was to analyze the influence of different particle characterization methods performed by three research centers within the scope of a "round robin test". To obtain knowledge about possible pitfalls, single steps of the particle characterization process (storage, pore size of the filter, coating durations by gold sputtering and scanning electron microscopy (SEM) magnification) were analyzed. The round robin test showed significant differences between the research groups, especially for the morphology of the particles. The SEM magnification was identified as having the greatest influence on the size and shape of the particles, followed by the storage conditions of the wear particle containing lubricant. Gold sputter coating and filter pore size also exhibit significant effects. However, even though they are statistically significant, it should be emphasized that the differences are small. In conclusion, particle characterization is a complex analytical method with a multiplicity of influencing factors. It becomes apparent that a comparison of wear particle results between different research groups is challenging.

Wear performance of ceramic-on-metal hip bearings.

Ceramic-on-metal (CoM) bearings are considered to be a promising alternative to polyethylene-based bearings or hard-on-hard bearings (Ceramic-on-Ceramic (CoC) and Metal-on-Metal (MoM)). Although, CoM shows lower wear rates than MoM, in-vitro wear testing of CoM shows widely varying results. This may be related to limitations of wear-measuring methods. Therefore, the aim of this study was to improve the gravimetric measurement technique and to test wear behaviour of CoM bearings compared to CoC bearings. Level walking according to ISO-14242 was simulated for four CoM and four CoC bearings. Prior to simulation, errors in measurement of gravimetric wear were detected and improvements in measurement technique incorporated. The results showed no differences in mean wear rates between CoM and CoC bearings. However, the CoM bearings showed wear results over a wide range of wear performance. High reliability of wear results was recorded for the CoC bearings. Material transfer was observed on the ceramic heads of the CoM bearings. Therefore, for level walking a partial mixed or boundary lubrication has to be assumed for this type of bearing. CoM is a highly sensitive wear-couple. The reasons for the observed behaviour cannot be clarified from this study. Simulator studies have to be considered as an ideal loading condition. Therefore, high variations in wear rates as seen in this study, even at low levels, may have an adverse effect on the in-vivo wear behavior. Careful clinical use may be advisable until the reasons for the variation are fully clarified and understood.

Wear analysis of unicondylar mobile bearing and fixed bearing knee systems: a knee simulator study.

Unicondylar knee arthroplasty is an attractive alternative to total knee arthroplasty for selected patients with osteoarthritis. Mobile bearing knee designs have been developed to improve knee kinematics, lower contact stresses and reduced wear of ultra-high molecular weight polyethylene compared with fixed bearing designs. This study compared in vitro wear behavior of fixed and mobile unicondylar bearing designs. Analysis was performed using a force-controlled AMTI knee simulator according to ISO 14243-1:2002(E). The wear volume of the implants was determined gravimetrically. Optical surface characterization and an estimation of wear particle size and morphology were performed. Implant kinematic data for both designs were determined. The wear rates averaged 10.7 ± 0.59 mg per 10(6) cycles for the medial and 5.38 ± 0.63 mg per 10(6) cycles for the lateral components of the mobile bearings, compared with 7.51 ± 0.29 mg per 10(6) cycles and 3.04 ± 0.35 mg per 10(6) cycles for the fixed bearings. The mobile bearings therefore exhibited higher wear rates (P<0.01) compared with the fixed bearings. The tibial polyethylene inserts of the mobile bearings showed pronounced backside wear at the inferior surface. The kinematics of both designs was similar. However, anterior-posterior translation was lower in the mobile bearings. The wear particles were mainly elongated and small in size for both designs (P=0.462). This study shows that wear may play an important role in unicondylar mobile bearing knee designs. Advantages of unicondylar mobile designs compared with fixed bearing designs, which have been proposed in terms of wear behavior and improved kinematics, could not be confirmed.