Overset meshing in combination with novel blended weak-strong fluid-structure interactions for simulations of a translating valve in series with a second valve.

Mechanical circulatory support (MCS) devices can bridge the gap to transplant whilst awaiting a viable donor heart. The Realheart Total Artificial Heart is a novel positive-displacement MCS that generates pulsatile flow via bileaflet mechanical valves. This study developed a combined computational fluid dynamics and fluid-structure interaction (FSI) methodology for simulating positive displacement bileaflet valves. Overset meshing discretised the fluid domain, and a blended weak-strong coupling FSI algorithm was combined with variable time-stepping. Four operating conditions of relevant stroke lengths and rates were assessed. The results demonstrated this modelling strategy is stable and efficient for modelling positive-displacement artificial hearts.

Personalised 3D Printed high tibial osteotomy achieves a high level of accuracy: 'IDEAL' preclinical stage evaluation of a novel patient specific system.

High tibial osteotomy (HTO) is an effective surgical treatment for isolated medial compartment knee osteoarthritis; however, widespread adoption is limited due to difficulty in achieving the planned correction, and patient dissatisfaction due to soft tissue irritation. The aim of this study was to assess the accuracy of a novel HTO system with 3D printed patient specific implants and surgical guides using cadaveric specimens. Local ethics committee approval was obtained. The novel opening wedge HTO procedure was performed on eight cadaver leg specimens. Whole lower limb CT scans pre- and post-operatively provided geometrical assessment quantifying the discrepancy between pre-planned and post-operative measurements for key variables: the gap opening angle and the patient specific surgical instrumentation positioning. The average discrepancy between the pre-operative plan and the post-operative osteotomy correction angle was: 0.0 ±â€ˆ0.2° The R2 value for the regression correlation was 0.95. The average error in implant positioning was -0.4 ±â€ˆ4.3 mm, -2.6 ±â€ˆ3.4 mm and 3.1 ±â€ˆ1.7° vertically, horizontally, and rotationally respectively. This novel HTO surgery has greater accuracy in correction angle achieved compared to that reported for conventional or other patient specific methods with published data available. This system could potentially improve the accuracy of osteotomy correction angles achieved surgically.

Machine learning outperforms clinical experts in classification of hip fractures.

Hip fractures are a major cause of morbidity and mortality in the elderly, and incur high health and social care costs. Given projected population ageing, the number of incident hip fractures is predicted to increase globally. As fracture classification strongly determines the chosen surgical treatment, differences in fracture classification influence patient outcomes and treatment costs. We aimed to create a machine learning method for identifying and classifying hip fractures, and to compare its performance to experienced human observers. We used 3659 hip radiographs, classified by at least two expert clinicians. The machine learning method was able to classify hip fractures with 19% greater accuracy than humans, achieving overall accuracy of 92%.

Acute regional changes in myocardial strain may predict ventricular remodelling after myocardial infarction in a large animal model.

To identify predictors of left ventricular remodelling (LVR) post-myocardial infarction (MI) and related molecular signatures, a porcine model of closed-chest balloon MI was used along with serial cardiac magnetic resonance imaging (CMRI) up to 5-6 weeks post-MI. Changes in myocardial strain and strain rates were derived from CMRI data. Tissue proteomics was compared between infarcted and non-infarcted territories. Peak values of left ventricular (LV) apical circumferential strain (ACS) changed over time together with peak global circumferential strain (GCS) while peak GLS epicardial strains or strain rates did not change over time. Early LVR post-MI enhanced abundance of 39 proteins in infarcted LV territories, 21 of which correlated with LV equatorial circumferential strain rate. The strongest associations were observed for D-3-phosphoglycerate dehydrogenase (D-3PGDH), cysteine and glycine-rich protein-2, and secreted frizzled-related protein 1 (sFRP1). This study shows that early changes in regional peak ACS persist at 5-6 weeks post-MI, when early LVR is observed along with increased tissue levels of D-3PGDH and sFRP1. More studies are needed to ascertain if the observed increase in tissue levels of D-3PGDH and sFRP1 might be casually involved in the pathogenesis of adverse LV remodelling.

Correction to: Solochrome cyanine: A histological stain for cobalt-chromium wear particles in metal-on-metal periprosthetic tissues.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Solochrome cyanine: A histological stain for cobalt-chromium wear particles in metal-on-metal periprosthetic tissues.

Metal-on-metal (MoM) hip arthroplasties produce abundant implant-derived wear debris composed mainly of cobalt (Co) and chromium (Cr). Cobalt-chromium (Co-Cr) wear particles are difficult to identify histologically and need to be distinguished from other wear particle types and endogenous components (e.g., haemosiderin, fibrin) which may be present in MoM periprosthetic tissues. In this study we sought to determine whether histological stains that have an affinity for metals are useful in identifying Co-Cr wear debris in MoM periprosthetic tissues. Histological sections of periprosthetic tissue from 30 failed MoM hip arthroplasties were stained with haematoxylin-eosin (HE), Solochrome Cyanine (SC), Solochrome Azurine (SA) and Perls' Prussian Blue (PB). Sections of periprosthetic tissue from 10 cases of non-MoM arthroplasties using other implant biomaterials, including titanium, ceramic, polymethylmethacrylate (PMMA) and ultra-high molecular weight polyethylene (UHMWP) were similarly analysed. Sections of 10 cases of haemosiderin-containing knee tenosynovial giant cell tumour (TSGCT) were also stained with HE, SC, SA and PB. In MoM periprosthetic tissues, SC stained metal debris in phagocytic macrophages and in the superficial necrotic zone which exhibited little or no trichrome staining for fibrin. In non-MoM periprosthetic tissues, UHMWP, PMMA, ceramic and titanium particles were not stained by SC. Prussian Blue, but not SC or SA, stained haemosiderin deposits in MoM periprosthetic tissues and TSGT. Our findings show that SC staining (most likely Cr-associated) is useful in distinguishing Co-Cr wear particles from other metal/non-metal wear particles types in histological preparations of periprosthetic tissue and that SC reliably distinguishes haemosiderin from Co-Cr wear debris.

Are there clinically relevant anatomical differences of the proximal femur in patients with mild dysplastic and primary hip osteoarthritis? A CT-based matched-pairs cohort study.

AIM: To investigate the three-dimensional anatomy and shape of the proximal femur, comparing patients with secondary osteoarthritis (OA) due to mild developmental dysplasia of the hip (DDH) and primary hip OA. MATERIALS AND METHODS: This retrospective radiographic computed tomography (CT)-based study investigated proximal femoral anatomy in a consecutive series of 84 patients with secondary hip OA due to mild DDH (Crowe type I&II/Hartofilakidis A) compared to 84 patients with primary hip OA, matched for gender, age at surgery, and body mass index. RESULTS: Men with DDH showed higher neck shaft angles (127±5° vs. 123±4°; p<0.001), whereas women with DDH had a larger femoral head diameter (46±4 vs. 44±3 mm; p=0.002), smaller femoral offset (36±5 vs. 40±4 mm; p<0.001), decreased leg torsion (25±13° vs. 31±16°; p=0.037), and a higher neck shaft angle (128±7° vs. 123±4°; p<0.001) compared to primary OA patients. Similar patterns of the three-dimensional endosteal canal shape of the proximal femur, but a high inter-individual variability for femoral canal torsion at the meta-diaphyseal level were found for DDH and primary OA patients. CONCLUSION: Standard cementless stem designs are suitable to treat patients with secondary hip OA due to mild DDH; however, high patient variability and subtle anatomical differences in the proximal femur should be respected.

Pelvic positioning in the supine position leads to more consistent orientation of the acetabular component after total hip arthroplasty.

AIMS: This study aims to: determine the difference in pelvic position that occurs between surgery and radiographic, supine, postoperative assessment; examine how the difference in pelvic position influences subsequent component orientation; and establish whether differences in pelvic position, and thereafter component orientation, exist between total hip arthroplasties (THAs) performed in the supine versus the lateral decubitus positions. PATIENTS AND METHODS: The intra- and postoperative anteroposterior pelvic radiographs of 321 THAs were included; 167 were performed with the patient supine using the anterior approach and 154 were performed with the patient in the lateral decubitus using the posterior approach. The inclination and anteversion of the acetabular component was measured and the difference (Δ) between the intra- and postoperative radiographs was determined. The target zone was inclination/anteversion of 40°/20° (± 10°). Changes in the tilt, rotation, and obliquity of the pelvis on the intra- and postoperative radiographs were calculated from Δinclination/anteversion using the Levenberg-Marquardt algorithm. RESULTS: The mean postoperative inclination/anteversion was 40° (± 8°)/23° (± 9°) with Δinclination and/or Δanteversion > ± 10° in 74 (21%). Intraoperatively, the pelvis was anteriorly tilted by a mean of 4° (± 10°), internally rotated by a mean of 1° (± 10°) and adducted by a mean of 1° (± 5°). Having Δinclination and/or Δanteversion > ± 10° was associated with a 3.5 odds ratio of having the acetabular component outside the target zone. A greater proportion of THAs that were undertaken with the patient in the lateral decubitus position had Δinclination and/or Δanteversion > ± 10° (35.3%, 54/153) compared with those in the supine position (4.8%, 8/167; p < 0.001). A greater number of acetabular components were within the target zone in THAs undertaken with the patient in the supine position (72%, 120/167), compared with those in the lateral decubitus position (44%, 67/153; p < 0.001). Intraoperatively, the pelvis was more anteriorly tilted (p < 0.001) and more internally rotated (p = 0.04) when the patient was in the lateral decubitus position. CONCLUSION: The pelvic position is more reliable when the patient is in the supine position, leading to more consistent orientation of the acetabular component. Significant differences in pelvic tilt and rotation are seen with the patient in the lateral decubitus position. Cite this article: Bone Joint J 2018;100-B:1280-8.

Juvenile bovine bone is an appropriate surrogate for normal and reduced density human bone in biomechanical testing: a validation study.

Orthopaedic research necessitates accurate and reliable models of human bone to enable biomechanical discoveries and translation into clinical scenarios. Juvenile bovine bone is postulated to be a potential model of normal human bone given its dimensions and comparatively reduced ethical restrictions. Demineralisation techniques can reduce bone density and alter bone properties, and methods to model osteoporotic bone using demineralised juvenile bovine bone are investigated. Juvenile bovine long bones were quantitatively CT scanned to assess bone density. Demineralisation using hydrochloric acid (0.6, 1.2 and 2.4 M) was performed to create different bone density models which underwent biomechanical validation for normal and osteoporotic bone models. All long bones were found to have comparable features to normal human bone including bone density (1.96 ± 0.08 gcm-3), screw insertion torque and pullout strength. Demineralisation significantly reduced bone density and pullout strength for all types, with 0.6 M hydrochloric acid creating reductions of 25% and 71% respectively. Juvenile bovine bone is inexpensive, easy to source and not subject to extensive ethical procedures. This study establishes for the first time, the use of its long bones as surrogates for both normal and osteoporotic human specimens and offers preliminary validation for its use in biomechanical testing.

The effect of plate design, bridging span, and fracture healing on the performance of high tibial osteotomy plates: An experimental and finite element study.

OBJECTIVES: Opening wedge high tibial osteotomy (HTO) is an established surgical procedure for the treatment of early-stage knee arthritis. Other than infection, the majority of complications are related to mechanical factors - in particular, stimulation of healing at the osteotomy site. This study used finite element (FE) analysis to investigate the effect of plate design and bridging span on interfragmentary movement (IFM) and the influence of fracture healing on plate stress and potential failure. MATERIALS AND METHODS: A 10° opening wedge HTO was created in a composite tibia. Imaging and strain gauge data were used to create and validate FE models. Models of an intact tibia and a tibia implanted with a custom HTO plate using two different bridging spans were validated against experimental data. Physiological muscle forces and different stages of osteotomy gap healing simulating up to six weeks postoperatively were then incorporated. Predictions of plate stress and IFM for the custom plate were compared against predictions for an industry standard plate (TomoFix). RESULTS: For both plate types, long spans increased IFM but did not substantially alter peak plate stress. The custom plate increased axial and shear IFM values by up to 24% and 47%, respectively, compared with the TomoFix. In all cases, a callus stiffness of 528 MPa was required to reduce plate stress below the fatigue strength of titanium alloy. CONCLUSION: We demonstrate that larger bridging spans in opening wedge HTO increase IFM without substantially increasing plate stress. The results indicate, however, that callus healing is required to prevent fatigue failure.Cite this article: A. R. MacLeod, G. Serrancoli, B. J. Fregly, A. D. Toms, H. S. Gill. The effect of plate design, bridging span, and fracture healing on the performance of high tibial osteotomy plates: An experimental and finite element study. Bone Joint Res 2018;7:639-649. DOI: 10.1302/2046-3758.712.BJR-2018-0035.R1.

A novel flexible capacitive load sensor for use in a mobile unicompartmental knee replacement bearing: An in vitro proof of concept study.

Instrumented knee replacements can provide in vivo data quantifying physiological loads acting on the knee. To date instrumented mobile unicompartmental knee replacements (UKR) have not been realised. Ideally instrumentation would be embedded within the polyethylene bearing. This study investigated the feasibility of an embedded flexible capacitive load sensor. A novel flexible capacitive load sensor was developed which could be incorporated into standard manufacturing of compression moulded polyethylene bearings. Dynamic experiments were performed to determine the characteristics of the sensor on a uniaxial servo-hydraulic material testing machine. The instrumented bearing was measured at sinusoidal frequencies between 0.1 and 10Hz, allowing for measurement of typical gait load magnitudes and frequencies. These correspond to frequencies of interest in physiological loading. The loads that were applied were a static load of 390N, corresponding to an equivalent body weight load for UKR, and a dynamic load of ±293N. The frequency transfer response of the sensor suggests a low pass filter response with a -3dB frequency of 10Hz. The proposed embedded capacitive load sensor was shown to be applicable for measuring in vivo loads within a polyethylene mobile UKR bearing.

The efficacy of rotational control designs in promoting torsional stability of hip fracture fixation.

OBJECTIVES: Fractures of the proximal femur are a common clinical problem, and a number of orthopaedic devices are available for the treatment of such fractures. The objective of this study was to assess the rotational stability, a common failure predictor, of three different rotational control design philosophies: a screw, a helical blade and a deployable crucifix. METHODS: Devices were compared in terms of the mechanical work (W) required to rotate the implant by 6° in a bone substitute material. The substitute material used was Sawbones polyurethane foam of three different densities (0.08 g/cm3, 0.16 g/cm3 and 0.24 g/cm3). Each torsion test comprised a steady ramp of 1°/minute up to an angular displacement of 10°. RESULTS: The deployable crucifix design (X-Bolt), was more torsionally stable, compared to both the dynamic hip screw (DHS, p = 0.008) and helical blade (DHS Blade, p= 0.008) designs in bone substitute material representative of osteoporotic bone (0.16 g/cm3 polyurethane foam). In 0.08 g/cm3 density substrate, the crucifix design (X-Bolt) had a higher resistance to torsion than the screw (DHS, p = 0.008). There were no significant differences (p = 0.101) between the implants in 0.24 g/cm3 density bone substitute. CONCLUSIONS: Our findings indicate that the clinical standard proximal fracture fixator design, the screw (DHS), was the least effective at resisting torsional load, and a novel crucifix design (X-Bolt), was the most effective design in resisting torsional load in bone substitute material with density representative of osteoporotic bone. At other densities the torsional stability was also higher for the X-Bolt, although not consistently significant by statistical analysis.Cite this article: J. D. Gosiewski, T. P. Holsgrove, H. S. Gill. The efficacy of rotational control designs in promoting torsional stability of hip fracture fixation. Bone Joint Res 2017;6:270-276. DOI: 10.1302/2046-3758.65.BJR-2017-0287.R1.

Effect of trunnion roughness and length on the modular taper junction strength under typical intraoperative assembly forces.

Modular hip implants are at risk of fretting-induced postoperative complications most likely initiated by micromotion between adjacent implant components. A stable fixation between ball head and stem-neck taper is critical to avoid excessive interface motions. Therefore, the aim of this study was to identify the effect of trunnion roughness and length on the modular taper strength under typical intraoperative assembly forces. Custom-made Titanium trunnions (standard/mini taper, smooth/grooved surface finish) were assembled with modular Cobalt-chromium heads by impaction with peak forces ranging from 2kN to 6kN. After each assembly process these were disassembled with a materials testing machine to detect the pull-off force as a measure for the taper strength. As expected, the pull-off forces increased with rising peak assembly force (p < 0.001). For low and moderate assembly forces, smooth standard tapers offered higher pull-off forces compared to grooved tapers (p < 0.038). In the case of an assembly force of 2kN, mini tapers showed a higher taper strength than standard ones (p=0.037). The results of this study showed that smooth tapers provided a higher strength for taper junctions. This higher taper strength may reduce the risk of fretting-related complications especially in the most common range of intraoperative assembly forces.

Large-diameter total hip arthroplasty modular heads require greater assembly forces for initial stability.

OBJECTIVES: Modular junctions are ubiquitous in contemporary hip arthroplasty. The head-trunnion junction is implicated in the failure of large diameter metal-on-metal (MoM) hips which are the currently the topic of one the largest legal actions in the history of orthopaedics (estimated costs are stated to exceed $4 billion). Several factors are known to influence the strength of these press-fit modular connections. However, the influence of different head sizes has not previously been investigated. The aim of the study was to establish whether the choice of head size influences the initial strength of the trunnion-head connection. MATERIALS AND METHODS: Ti-6Al-4V trunnions (n = 60) and two different sizes of cobalt-chromium (Co-Cr) heads (28 mm and 36 mm; 30 of each size) were used in the study. Three different levels of assembly force were considered: 4 kN; 5 kN; and 6 kN (n = 10 each). The strength of the press-fit connection was subsequently evaluated by measuring the pull-off force required to break the connection. The statistical differences in pull-off force were examined using a Kruskal-Wallis test and two-sample Mann-Whitney U test. Finite element and analytical models were developed to understand the reasons for the experimentally observed differences. RESULTS: 36 mm diameter heads had significantly lower pull-off forces than 28 mm heads when impacted at 4 kN and 5 kN (p < 0.001; p < 0.001), but not at 6 kN (p = 0.21). Mean pull-off forces at 4 kN and 5 kN impaction forces were approximately 20% larger for 28 mm heads compared with 36 mm heads. Finite element and analytical models demonstrate that the differences in pull-off strength can be explained by differences in structural rigidity and the resulting interface pressures. CONCLUSION: This is the first study to show that 36 mm Co-Cr heads have up to 20% lower pull-off connection strength compared with 28 mm heads for equivalent assembly forces. This effect is likely to play a role in the high failure rates of large diameter MoM hips.Cite this article: A. R. MacLeod, N. P. T. Sullivan, M. R. Whitehouse, H. S. Gill. Large-diameter total hip arthroplasty modular heads require greater assembly forces for initial stability. Bone Joint Res 2016;5:338-346. DOI: 10.1302/2046-3758.58.BJR-2016-0044.R1.

Influence of consciousness, muscle action and activity on medial condyle translation after Oxford unicompartmental knee replacement.

BACKGROUND: Quantification of the in vivo position of the medial condyle throughout flexion is important for knee replacement design, and understanding knee pathology. The influence of consciousness, muscle action, and activity type on condyle translation was examined in patients who had undergone medial unicompartmental knee replacement (UKR) using lateral video fluoroscopy. METHODS: The position of the centre of the femoral component relative to the tibial component was measured for nine patients under different conditions. The following activities were assessed; passive flexion and extension when anaesthetised, passive flexion and extension when conscious, and active flexion, extension and step-up. RESULTS: The position of the centre of the femoral component relative to the tibial component was highly patient dependent. The greatest average translation range (14.9 mm) was observed in anaesthetised patients, and the condyle was significantly more anterior near to extension. Furthermore, when conscious but being moved passively, the femoral condyle translated a greater range (8.9 mm) than when moving actively (5.2mm). When ascending stairs, the femoral condyle was more posterior at 20-30° of flexion than during flexion/extension. CONCLUSIONS: The similarity between these results and published data suggest that knee kinematics following mobile-bearing UKR is relatively normal. The results show that in the normal knee and after UKR, knee kinematics is variable and is influenced by the patient, consciousness, muscle action, and activity type. CLINICAL RELEVANCE: It is therefore essential that all these factors are considered during knee replacement design, if the aim is to achieve more normal knee kinematics.

The effect of orientation of the acetabular component on outcome following total hip arthroplasty with small diameter hard-on-soft bearings.

We assessed the orientation of the acetabular component in 1070 primary total hip arthroplasties with hard-on-soft, small diameter bearings, aiming to determine the size and site of the target zone that optimises outcome. Outcome measures included complications, dislocations, revisions and ΔOHS (the difference between the Oxford Hip Scores pre-operatively and five years post-operatively). A wide scatter of orientation was observed (2sd 15°). Placing the component within Lewinnek's zone was not associated withimproved outcome. Of the different zone sizes tested (± 5°, ± 10° and ± 15°), only ± 15° was associated with a decreased rate of dislocation. The dislocation rate with acetabular components inside an inclination/anteversion zone of 40°/15° ± 15° was four times lower than those outside. The only zone size associated with statistically significant and clinically important improvement in OHS was ± 5°. The best outcomes (ΔOHS > 26) were achieved with a 45°/25° ± 5° zone. This study demonstrated that with traditional technology surgeons can only reliably achieve a target zone of ±15°. As the optimal zone to diminish the risk of dislocation is also ±15°, surgeons should be able to achieve this. This is the first study to demonstrate that optimal orientation of the acetabular component improves the functional outcome. However, the target zone is small (± 5°) and cannot, with current technology, be consistently achieved.

Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial.

The most common reasons for revision of unicompartmental knee arthroplasty (UKA) are loosening and pain. Cementless components may reduce the revision rate. The aim of this study was to compare the fixation and clinical outcome of cementless and cemented Oxford UKAs. A total of 43 patients were randomised to receive either a cemented or a cementless Oxford UKA and were followed for two years with radiostereometric analysis (RSA), radiographs aligned with the bone-implant interfaces and clinical scores. The femoral components migrated significantly during the first year (mean 0.2 mm) but not during the second. There was no significant difference in the extent of migration between cemented and cementless femoral components in either the first or the second year. In the first year the cementless tibial components subsided significantly more than the cemented components (mean 0.28 mm (sd 0.17) vs. 0.09 mm (sd 0.19 mm)). In the second year, although there was a small amount of subsidence (mean 0.05 mm) there was no significant difference (p = 0.92) between cemented and cementless tibial components. There were no femoral radiolucencies. Tibial radiolucencies were narrow (< 1 mm) and were significantly (p = 0.02) less common with cementless (6 of 21) than cemented (13 of 21) components at two years. There were no complete radiolucencies with cementless components, whereas five of 21 (24%) cemented components had complete radiolucencies. The clinical scores at two years were not significantly different (p = 0.20). As second-year migration is predictive of subsequent loosening, and as radiolucency is suggestive of reduced implant-bone contact, these data suggest that fixation of the cementless components is at least as good as, if not better than, that of cemented devices.

The relationship between operative and radiographic acetabular component orientation: which factors influence resultant cup orientation?

There is great variability in acetabular component orientation following hip replacement. The aims of this study were to compare the component orientation at impaction with the orientation measured on post-operative radiographs and identify factors that influence the difference between the two. A total of 67 hip replacements (52 total hip replacements and 15 hip resurfacings) were prospectively studied. Intra-operatively, the orientation of the acetabular component after impaction relative to the operating table was measured using a validated stereo-photogrammetry protocol. Post-operatively, the radiographic orientation was measured; the mean inclination/anteversion was 43° (sd 6°)/ 19° (sd 7°). A simulated radiographic orientation was calculated based on how the orientation would have appeared had an on-table radiograph been taken intra-operatively. The mean difference between radiographic and intra-operative inclination/anteversion was 5° (sd 5°)/ -8° (sd 8°). The mean difference between simulated radiographic and intra-operative inclination/anteversion, which quantifies the effect of the different way acetabular orientation is measured, was 3°/-6° (sd 2°). The mean difference between radiographic and simulated radiographic orientation inclination/anteversion, which is a manifestation of the change in pelvic position between component impaction and radiograph, was 1°/-2° (sd 7°). This study demonstrated that in order to achieve a specific radiographic orientation target, surgeons should implant the acetabular component 5° less inclined and 8° more anteverted than their target. Great variability (2 sd about ± 15°) in the post-operative radiographic cup orientation was seen. The two equally contributing causes for this are variability in the orientation at which the cup is implanted, and the change in pelvic position between impaction and post-operative radiograph.

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.