Assessment of Head Displacement and Disassembly Force With Increasing Assembly Load at the Head/Trunnion Junction of a Total Hip Arthroplasty Prosthesis.

BACKGROUND: Most femoral components used now for total hip arthroplasty are modular, requiring a strong connection at assembly. The aim of this study was to assess the effect of assembly force on the strength of head-trunnion interface and to measure the initial displacement of the head on the trunnion with different assembly forces. METHODS: Three assembly load levels were assessed (A: 2 kN, B: 4 kN, C: 6 kN) with 4 implants in each group. The stems were mounted in a custom rig and the respective assembly loads were applied to the head at a constant rate of 0.05 kN/s (ISO7260-10:2003). Load levels were recorded during assembly. Head displacement was measured with a laser sensor. The disassembly force was determined by a standard pull-off test. RESULTS: The maximum head displacement on the trunnion was significantly different between the 2 kN group and the other 2 groups (4 kN, 6 kN, P = .029), but not between the 4 kN and 6 kN groups (P = .89). The disassembly forces between the 3 groups were significantly different (mean ± standard deviation, A: 1316 ± 223 kN; B: 2224 ± 151 kN; C: 3965 ± 344 kN; P = .007), with increasing assembly load leading to a higher pull-off force. For the 4 kN and 6 kN groups, a first peak of approximately 2.5 kN was observed on the load recordings during assembly before the required assembly load was eventually reached corresponding to sudden increase in head displacement to approximately 150 µm. CONCLUSION: An assembly force of 2 kN may be too low to overcome the frictional forces needed to engage the head and achieve maximum displacement on the trunnion and thus an assembly load of greater than 2.5 kN is recommended.

The force of Zein self-assembled nanoparticles and the application of functional materials in food preservation.

Zein self-assembled nanoparticles (Z-NPs) are an excellent delivery carrier for bioactive components. However, the poor stability of its application in the food industry is the main problem. This paper focused on the self-assembly force of Z-NPs and the factors affecting the stability of Z-NPs. Meanwhile, the modification methods of zein and its interaction with food additives were analyzed. Additionally, its application in the field of food preservation was reviewed. The main interactions between zein and polyphenols encompass hydrogen bonding, non-covalent interactions, and hydrophobic interactions. Besides, the interactions with polysaccharides involve both covalent and non-covalent interactions. Furthermore, the protein interactions entail hydrophobic interactions, electrostatic interactions, hydrogen bonds, and π-π stacking. The primary driving forces governing zein self-assembly encompass electrostatic interactions, hydrogen bonding, van der Waals forces, hydrophobic interactions, and π-π stacking. Meanwhile, functionalized Z-NPs can be used in the food preservation industry to prolong the shelf life of food.

Sensitivity and Stability Study of Test Conditions for a 1 kW Proton Exchange Membrane Fuel Cell Stack.

This study investigates the impact of compression force on stack performance and the effect of testing conditions on sensitivity of stack performance. It explores the variation of assembly force on the pressure distribution at different positions in a 1 kW proton exchange membrane fuel cell stack. Polarization curves and high-frequency resistance (HFR) changes of the stack were measured under different assembly forces, and the optimal assembly force of the stack was determined using the average single-cell voltage (HFR-free). The sensitivity of testing conditions was optimized, and the optimum test parameters at different current densities were identified within the selected range. Stack stability was tested at different current densities using the optimized test conditions, and the sensitivity of test conditions was verified by the fluctuation amplitude of single cell voltage and internal impedance.

Large deformation analysis of a backside-supported snap-fit with nonlinear behavior.

In this study, the large deformation of a backside-supported snap-fit was analyzed. The backside snap-fit pair consisted of mating part and base part. The mating part was a simple cantilever, and the base part had an opening with a supporting bar. The reaction force of the supporting bar was found to be an important parameter for the assembly and separation of the snap-fit. During our analysis, the supporting bar experienced a large deformation with nonlinear elasticity or plastic damage. Finite element analysis was performed. Stress concentration was observed at the root of the supporting bar and at the bent edge of the base part. Three types of specimens were designed and fabricated for experimental verification. The first specimen was a reference design that was fabricated according to the same design concept as the actual product. The second specimen was designed to reduce the stress concentration. The third specimen had an enriched design to increase the supporting force. The reaction force corresponding to the applied displacement was measured using a testing machine. The load exhibited a highly nonlinear behavior and reached a maximum peak value without causing any apparent damage, after which it decreased with plastic damage. Through numerical and experimental analyses, it was found out that the design of the backside-supported snap-fit could be improved by reducing the stress concentration and increasing the stiffness of the supporting bar.

The Role of the Assembly Force in the Tribocorrosion Behaviour of Hip Implant Head-Neck Junctions: An Adaptive Finite Element Approach.

The cyclic loading, in the corrosive medium of the human body, results in tribocorrosion at the interface of the head-neck taper junction of hip implants. The resulting metal ions and wear debris adversely affect the local tissues. The force applied by surgeons to assemble the junction has proven to play a major role in the mechanics of the taper junction which, in turn, can influence the tribocorrosion damage. Recently, finite element method has been used to predict the material loss at the head-neck interface. However, in most finite element studies, the contribution of electrochemical corrosion has been ignored. Therefore, a detailed study to investigate the influence of the assembly force on the tribocorrosive behaviour of the head-neck junction, which considers both the mechanical and chemical material removal, is of paramount interest. In this study, a finite-element-based algorithm was used to investigate the effect of assembly force on the tribocorrosion damage at the junction interface, for over four million cycles of simulated level gait. The patterns of the material removal in the modelling results were compared with the damage patterns observed in a group of retrieved modular hip implants. The results of this study showed that for different cases, chemical wear was in the range of 25-50% of the total material loss, after four million cycles. A minimum assembly force (4 kN for the studied cases) was needed to maintain the interlock in the junction. The computational model was able to predict the damage pattern at the retrieved head-neck interface.

Intraoperative assembly of anatomical shoulder prosthesis frequently results in malalignment of the modular taper junction.

Anatomical shoulder arthroplasties (ASA) may fail because of micromotion at the modular taper junction causing wear due to fretting. Sufficient taper strength can reduce micromotion and potential reasons for failure. However, there are no normative standards for a safe assembly process performed intraoperatively by the surgeon. The purpose of this study is to determine the effect of common intraoperative assembly strategies and to identify critical influencing factors on taper stability. ASA with standard and stemless humeral component in combination with concentric Al2 O3 heads and eccentric CoCr28Mo6 alloyed humeral heads were tested. Taper angles and surface roughness were determined. Force magnitudes and impact directions were recorded using a sensorized head impactor and a three-dimensional force measuring platform. Subsequently, the axial pull-off forces were measured and taper engagement areas were macroscopically evaluated. In comparison to standard stem tapers that were impacted with an assembly device, stemless tapers were impacted into the artificial bone with significantly lower forces. Taper strength correlates to maximum impact force and was higher for CoCr28Mo6 heads with a mean pull-off ratio of 0.56 than for Al2 O3 heads with 0.37. Interestingly, all tapers showed an asymmetric clamping behavior, due to tilting during impaction. This is caused by the variation of the resulting force vector and further promoted by humeral head eccentricity. Assembly technique markedly influences the force magnitude, impact direction, impulse, and consequently taper strength. The resulting force vector and head eccentricity were identified as potential risk factors for taper malalignment.

Quantification of assembly forces during creation of head-neck taper junction considering soft tissue bearing: a biomechanical study.

BACKGROUND: All current total hip arthroplasty (THA) systems are modular in design. Only during the operation femoral head and stem get connected by a Morse taper junction. The junction is realized by hammer blows from the surgeon. Decisive for the junction strength is the maximum force acting once in the direction of the neck axis, which is mainly influenced by the applied impulse and surrounding soft tissues. This leads to large differences in assembly forces between the surgeries. This study aimed to quantify the assembly forces of different surgeons under influence of surrounding soft tissue. METHODS: First, a measuring system, consisting of a prosthesis and a hammer, was developed. Both components are equipped with a piezoelectric force sensor. Initially, in situ experiments on human cadavers were carried out using this system in order to determine the actual assembly forces and to characterize the influence of human soft tissues. Afterwards, an in vitro model in the form of an artificial femur (Sawbones Europe AB, Malmo, Sweden) with implanted measuring stem embedded in gelatine was developed. The gelatine mixture was chosen in such a way that assembly forces applied to the model corresponded to those in situ. A study involving 31 surgeons was carried out on the aforementioned in vitro model, in which the assembly forces were determined. RESULTS: A model was developed, with the influence of human soft tissues being taken into account. The assembly forces measured on the in vitro model were, on average, 2037.2 N ± 724.9 N, ranging from 822.5 N to 3835.2 N. The comparison among the surgeons showed no significant differences in sex (P = 0.09), work experience (P = 0.71) and number of THAs performed per year (P = 0.69). CONCLUSIONS: All measured assembly forces were below 4 kN, which is recommended in the literature. This could lead to increased corrosion following fretting in the head-neck interface. In addition, there was a very wide range of assembly forces among the surgeons, although other influencing factors such as different implant sizes or materials were not taken into account. To ensure optimal assembly force, the impaction should be standardized, e.g., by using an appropriate surgical instrument.

Micromotion at the head-stem taper junction of total hip prostheses is influenced by prosthesis design-, patient- and surgeon-related factors.

Taper junctions of modular hip prostheses are susceptible to fretting and crevice corrosion. Prevalence and significance increase for cobalt-chromium heads assembled on titanium-alloy stems. Retrieval and in-vitro studies have identified micromotion between the taper components to accelerate the corrosion process. The aim of this study was to identify the most critical factors contributing to increased micromotion, which is most likely influenced by design-, patient- and surgeon-related aspects. Micromotion between head and stem taper surfaces was measured for different taper surface topographies and load orientations. Consecutive visual images were recorded through windows in the head component. By image matching analysis the local micromotions at the taper junction between head and stem tapers were determined. To extend the findings to taper regions not visible through the windows, finite element models were generated. The models were further utilized to investigate the influence of head length, taper angle difference and assembly force on micromotion. Significantly higher micromotion (+20%) was found under varus loading (7.1 µm) in comparison to valgus loading (5.9 µm). Smooth and microgrooved stem tapers exhibited equal amounts of micromotion. The numerical model revealed head tilting and recurring taper contact changes in terms of cyclic engagement/disengagement during the loading sequences. Especially long heads (+240%) and low assembly forces (+53%) were found to substantially increase micromotion (from 2.7 µm to 9.3 µm and from 4.1 µm to 8.8 µm, respectively). This study accentuates the susceptibility of taper junctions to a variety of factors, which need to be appreciated in preoperative planning and surgical procedure to reduce the amount of micromotion and such minimize the risk of critical corrosion.

Evaluation of pull-off strength and seating displacement of sleeved ceramic revision heads in modular hip arthroplasty.

Corrosion in revision total hip arthroplasty can be mitigated using a ceramic head on a well-fixed in situ stem, but concerns of their early failure because of any surface defects on in situ stem necessitates the use of a titanium sleeve, which furnishes a factory-finish surface. These sleeves are manufactured in different sizes allowing neck-length adjustment. The strength of the taper junction of non-sleeved primary heads is well-investigated, but the influence of an interposed titanium sleeve on achieving a secure taper lock is unclear. Therefore, this study aimed to investigate the pull-off strength and seating displacement of revision ceramic heads and titanium taper sleeves. Two different head diameters and two different taper adapter sleeve offset lengths were mated with trunnions at two different impaction forces. The seating displacement and pull-off force was recorded for each specimen. Profilometry of the grooved outer surfaces of the sleeve and trunnion was done before and after testing to analyze the change in surface roughness. The influence of head diameter, sleeve offset, and impaction force on seating displacement and pull-off force was analyzed using analysis of covariance. Pull-off forces for 6 kN assembly force were approximately three times those for 2 kN. The head diameter did not have a significant effect on the measured parameters. Compared with short offset length sleeves, extra-long increased seating displacement by 31% and reduced pull-off forces by 15%. While sleeves of different offset lengths permit control of neck length, surgeons must be careful of the impact of this choice on the stability of implant. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 38:1523-1528, 2020.

Determination of local micromotion at the stem-neck taper junction of a bi-modular total hip prosthesis design.

High rates of clinical complications with bi-modular hip prostheses are attributed to failure of the stem-neck taper junction. Taper wear analyses have shown extensive material loss as a result of corrosion, potentially initiated by micromotion. The purpose of the study was to determine the amount of micromotion at this junction for different loading, assembly and material conditions. Micromotion between the neck adapter (CoCr29Mo6-alloy) and the stem (TiMo12Zr6Fe2-alloy; both Rejuvenate, Stryker) within the taper junction of a bi-modular hip stem were determined by image matching analysis of consecutively recorded images through windows in the stem component. A finite element model was used to determine the micromotion in the taper regions outside the windows and validated with the measured micromotion. With the model, the influence of the load amplitude, assembly force and component materials were then investigated. Determined micromotion (14-79 µm) by far exceeded critical values (5 µm) associated with the onset of fretting corrosion. Increasing assembly forces achieved a significant reduction in micromotion. The numerical model revealed insufficient assembly to cause the neck to perform rocking motions under load, repetitively changing taper contact in combination with gap opening, which facilitates fluid ingress into the junction. Changing the stem material to a stiffer Ti-alloy achieved a reduction of the micromotion of about 30%. This study emphasises the high importance of material selection, assembly force and loading on the susceptibility of bi-modular hip stems to fretting and crevice corrosion. These findings can serve to explain the increased rate of clinically reported problems with this particular prosthesis design.

Effect of impact assembly on the interface deformation and fretting corrosion of modular hip tapers: An in vitro study.

Wear and corrosion at the modular head-neck junction has been recognised to be a potential clinical concern, with multiple reports on adverse local tissue reactions and subsequent early failure of metal-on-metal hip replacements. Furthermore, reports on head-neck taper corrosion are also being described with conventional metal-on-polyethylene bearings. Manufacturing tolerances, surgical technique, non-axial alignment, material combination, high frictional torque and high bending moment have all been implicated in the failure process. There is limited guidance on the force of impaction with which surgeons should assemble modular hip prostheses. This study aims to investigate the effect of impaction force on the deformation and corrosion of modular tapers. Short neck tapers with high surface roughness (average Rz = 16.58 µm, Ra = 4.14µm) and long neck tapers with low surface roughness (average Rz = 3.82 µm, Ra = 0.81µm), were assembled with CoCrMo alloy heads (smooth finish) under controlled conditions with 2, 4 or 8 kN of impaction force. Material combinations tested included CoCrMo-head/CoCrMo-neck and CoCrMo-head/Ti-6Al-4V-neck. Assessment of surface deformation before and after impaction was made using surface profilometry. Measurement of fretting current during sinusoidal cyclic loading evaluated mechanically assisted corrosion for each assembly load during short-term cyclic loading (1000-cycles) and long-term cyclic loading (5 million-cycles). Deformation on head and neck tapers increased with assembly load. Fretting currents during short term simulation testing showed significantly lower currents (p < 0.05), in 8 kN assemblies when compared to 2 and 4 kN, especially for the short-rough tapers. Long-term simulator testing demonstrated a progressive reduction in fretting corrosion for samples impacted with 4 and 8 kN; however, this reduction was greater for samples impacted at 8 kN even at the start of testing. Based on our results, surgeons could minimise mechanically assisted crevice corrosion by using higher impact loads when assembling the head to the stem in total hip arthroplasty. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:405-416, 2018.

Assembly force and taper angle difference influence the relative motion at the stem-neck interface of bi-modular hip prostheses.

Bi-modular hip arthroplasty prostheses allow adaptation to the individual patient anatomy and the combination of different materials but introduce an additional interface, which was related lately to current clinical issues. Relative motion at the additional taper interface might increase the overall risk of fretting, corrosion, metallic debris and early failure. The aim of this study was to investigate whether the assembly force influences the relative motion and seating behaviour at the stem-neck interface of a bi-modular hip prosthesis (Metha(®); Aesculap AG, Tuttlingen, Germany) and whether this relation is influenced by the taper angle difference between male and female taper angles. Neck adapters made of titanium (Ti6Al4V) and CoCr (CoCr29Mo) were assembled with a titanium stem using varying assembly forces and mechanically loaded. A contactless eddy current measurement system was used to record the relative motion between prosthesis stem and neck adapter. Higher relative motion was observed for Ti neck adapters compared to the CoCr ones (p < 0.001). Higher assembly forces caused increased seating distances (p < 0.001) and led to significantly reduced relative motion (p = 0.019). Independent of neck material type, prostheses with larger taper angle difference between male and female taper angles exhibited decreased relative motion (p < 0.001). Surgeons should carefully use assembly forces above 4 kN to decrease the amount of relative motion within the taper interface. Maximum assembly forces, however, should be limited to prevent periprosthetic fractures. Manufacturers should optimize taper angle differences to increase the resistance against relative motion.

Influence of geometry and materials on the axial and torsional strength of the head-neck taper junction in modular hip replacements: A finite element study.

The assembly force is important in establishing the mechanical environment at the head-neck taper junction of modular hip replacements. Previous experimental results of the assembled taper junctions with different material combinations (Co-28Cr-6Mo and Ti-6Al-4V) reported similar axial strengths (pull-off loads), but lower torsional strengths (twist-off moments) for the CoCr/CoCr junction. However, mechanics of the junction and the strength behaviour have not been understood yet. A three dimensional finite element model of an isolated femoral head-neck junction was developed to explore the assembly and disassembly procedures, particularly the axial and torsional strengths for different material combinations and geometries. Under the same assembly load, the contacting length between the CoCr head and titanium neck was greater than that of in CoCr/CoCr. The contact length in the titanium neck was more sensitive to the assembly force when compared to the CoCr neck. For instance, with increasing the assembly force from 1890 to 3700N, the contact length increased by 88% for CoCr/Ti and 59% for CoCr/CoCr junctions. The torsional strength of the junction was related to the lateral deformation of the neck material due to the applied moment. The angular mismatch existing between the head and neck components was found to play the main role in the torsional strength of the junction. The smaller mismatch angle the higher torsional strength. It is suggested to consider reducing the mismatch angle, particularly in CoCr/CoCr junctions, and ensure a sufficiently high assembly force is applied by impaction for this combination.

Low torque levels can initiate a removal of the passivation layer and cause fretting in modular hip stems.

Taper connections of modular hip prostheses are at risk of fretting and corrosion, which can result in reduced implant survival. The purpose of this study was to identify the minimum torque required to initiate a removal of the passivation layer at the taper interface as a function of assembly force and axial load. Titanium stems and cobalt-chromium heads were assembled with peak impaction forces of 4.5 kN or 6.0 kN and then mounted on a materials testing machine whilst immersed in Ringer's solution. The stems were subjected to a static axial load (1 kN or 3 kN) along the taper axis. After a period of equilibration, a torque ramp from 0 to 15 Nm was manually applied and the galvanic potential was continuously recorded. Prostheses assembled with a force of 6 kN required a significantly higher torque to start a removal of the passivation layer compared to those assembled with 4.5 kN (7.23±0.55 Nm vs. 3.92±0.97 Nm, p=0.029). No influence of the axial load on the fretting behaviour was found (p=0.486). The torque levels, which were demonstrated to initiate surface damage under either assembly force, can be readily reached during activities of daily living. The damage will be intensified in situations of large weight and high activity of the patient or malpositioning of the prosthesis.