Proceedings of the Institution of Mechanical Engineers,Part H: Journal of Engineering in Medicine

The objective of this study is to evaluate the influence of saline solution (0.9 per cent NaCl) on the tensile properties of freeze-stored tendons. Firstly, 170 pieces of chicken flexor digitorum profundus tendons were retrieved and wrapped in saline-soaked gauze before they were stored at -40 °. Then specimens were tensile tested at various time points over 360 days, scanning electron microscopy (SEM) was performed on fresh specimens, and specimens were freeze-stored for 233 days to investigate microstructure change after freeze storage. The mean values of strain ultimate tensile strength (UTS) did not deviate significantly (analysis of variance; p = 0.249) following freeze storage while the UTS and elastic modulus increased gradually with the duration of freeze storage and the growth became significant (p < 0.01) for durations longer than 70 and 40 days respectively. The SEM study showed that the collagen fibre density of specimens stored for 233 days decreased because of porosity growth. These findings suggested that the saline increased the tensile strength and modulus of the collagen.

Measurement of the stiffness of spinal motion segments is widely used for evaluating the stability of spinal implant constructs. A three-dimensional motion analysis technique has been developed that allows accurate measurement of the relative movement of the vertebral bodies about a well-defined anatomical axis system. The position of marker clusters on each vertebra is tracked using digital infrared cameras (Qualisys AB, Gothenburg). Landmarks are identified using a marked pointer, and an anatomical coordinate system is defined for each vertebra. The transformation relating the upper and lower vertebrae is calculated, using the joint coordinate system approach of Grood and Suntay to find the rotations and translations in each anatomical plane.

The stiffness of vertebrectomy constructs was investigated using a Synex vertebral body replacement and an anterior rod with one or two screws in each vertebral body, with or without damage to the posterior longitudinal ligament (PLL). A moment of 2 N m was applied about each anatomical axis, and the range of motion about each axis was calculated.

The range of motion in flexion-extension and lateral bending was significantly greater with only one screw. When the PLL was cut, there was no significant increase in the range of motion.

In this, the first report of precision and accuracy in simulator studies, ceramic-ceramic implants with ultra-low wear trends represented a relevant wear model. The effect of test durations was examined in a standard simulator test mode on the quality of the linear regression trends, the average wear estimates, and the amount of noise in the data. Three sets of diametral tolerances were compared in 28 mm diameter alumina implants. The authors' hypothesis was that wear data would be significantly improved with increased test durations. The average wear rates varied little with test duration, the biggest change amounting to only 30 and 15 per cent decreases in the wear estimate by 10 and 14 million cycles respectively. The most satisfactory improvement in the study was the decrease in variance (noise) with increasing duration, ±200 per cent at 5 million cycles reduced to ±55 per cent at 14 million cycles. The quality of the linear regression coefficients improved 150 per cent by 10 million cycles and 250 per cent by 14 million cycles. Overall the ceramic implants with highest diametral tolerances showed the least wear (15 per cent less, but not statistically significant). However, given such low wear rates for alumina liners, it was unlikely that any differences owing to diametral tolerances would be clinically significant in the typical patient.

Adequate cement pressurization during stem insertion improves the interdigitation of cement into bone. This increases the strength of the cement-bone interface, thus contributing to the reduction of the incidence of aseptic loosening, the commonest cause of revision surgery. This in-vitro study compared the cement pressurization achieved during insertion of four different stems of equivalent sizes: the Elite Plus (DePuy, UK), C-Stem (DePuy, UK), Exeter (Stryker, USA), and CPS-Plus (Plus Orthopedics, Switzerland). The maximum pressures attained at the time of stem insertion were recorded at proximal, mid and distal stem levels. The Elite Plus generated significantly higher distal pressures than the other stems. The CPS-Plus generated significantly greater proximal cement pressures than the Elite Plus, C-Stem, and Exeter prostheses. The triple taper of the C-Stem increased the cement pressurization medial to the stem.

The stem shape and the presence or absence of a proximal stem centralizer affect cement pressurization. The presence of a proximal stem centralizer, a large stem volume, and a lateral-medial taper are all factors associated with increased cement pressurization during stem insertion.

For testing purposes of prostheses at a preclinical stage, it is very valuable to have a generic modelling tool, which can be used to optimize implant features and to avoid poor designs being launched on to the market. The modelling tool should be fast, efficient, and multipurpose in nature; a finite element model is well suited to the purpose. The question posed in this study was whether it was possible to develop a mathematically fast and stable dynamic finite element model of a knee joint after total knee arthroplasty that would predict data comparable with published data in terms of (a) laxities and ligament behaviour, and (b) joint kinematics. The soft tissue structures were modelled using a relatively simple, but very stable, composite model consisting of a band reinforced with fibres. Ligament recruitment and balancing was tested with laxity simulations. The tibial and patellar kinematics were simulated during flexion-extension. An implicit mathematical formulation was used. Joint kinematics, joint laxities, and ligament recruitment patterns were predicted realistically. The kinematics were very reproducible and stable during consecutive flexion-extension cycles. Hence, the model is suitable for the evaluation of prosthesis design, prosthesis alignment, ligament behaviour, and surgical parameters with respect to the biomechanical behaviour of the knee.

The aim of this study was to investigate the effect of the interface condition between polymethyl methacrylate (PMMA) bone cement and the ultrahigh molecular weight (UHMWPE) glenoid component on cement stresses and glenoid component tilting in a finite element (FE) model. The background of this research is that most FE models assume bonding between the PMMA bone cement and the UHMWPE component, although it is very doubtful that this bonding is present.

An FE model of a cemented glenoid component was developed and a joint compression force and subluxation force of 725 and 350 N respectively were applied. The maximal principal stresses in the cement layer ranged between 21.30 and 32.18 MPa. Glenoid component tilting ranged between 0.943° and 0.513°.

It was found that the interface condition has a large effect on the maximal principal stresses and glenoid component tilting. Whether adhesion between the UHMWPE component and PMMA bone cement occurs is unknown beforehand and, as a result, design validation using the FE technique should be carried out both by using contact elements in combination with a coefficient of friction as well as by a full bonding at this interface.

A novel 12-station hip joint simulator with an anatomic position of the prosthesis was designed and built. The motion of the simulator consists of flexion-extension and abduction-adduction. The load is of the double-peak type. The validation test was done with three similar 28 mm CoCr-polyethylene joints in diluted calf serum lubricant for 3.3 × 10⁶ cycles. The bearing surfaces of the polyethylene cups were burnished, the CoCr heads were undamaged, the wear particles were in the 0.1-1 μm size range, and the mean wear factor of the polyethylene cups was 5.7 × 10⁻⁷ mm³/N m. These essential observations were in good agreement with clinical findings. In addition, three similar 50 mm CoCR/CoCr joints, representing the contemporary large-diameter metal-on-metal articulation were tested. The wear of the CoCr/CoCr joints was calculated from the Co and Cr concentrations of the used lubricant quantified with atomic absorption spectroscopy. The bearing surfaces of the CoCr/CoCr jonits showed mild criss-cross scratching only. The average wear factor of polyethylene cups was 275 times that of the CoCr/CoCr joints. The tribological behaviour of the large-dia. CoCr/CoCr appeared to be dominated by fluid film lubrication, as indicated by very low frictional heating and wear, making it tribologically superior to the conventional CoCr/polyethylene, and therefore very interesting clinically. In conclusion, the simulator proved to be a valid, reliable, practical, economical, and easy-to-operate tool for wear studies of various hip replacement designs.

Aseptic loosening of the tibial component is the major complication of total knee arthroplasty. There is an association between early excessive shear micromotion between the bone and the tray of the tibial component and late aseptic loosening. Using non-linear finite element analysis, whether a tibial tray with a circumferentially flanged rim and a mating cut in the proximal tibia could minimize bone-tray shear micromotion was considered. fifteen competing tray designs with various degrees of flange curvature were assessed with the aim of minimizing bone-tray shear micromotion. A trade-off was found between reducing micromotion and increasing peripheral cancellous bone stresses. It was found that, within the limitations of the study, there was a theoretical design that could virtually eliminate micromotion due to axial loads, with minimal bone removal and without the use of screws or pegs.

Wear of total knee replacements is determined gravimetrically in simulator studies. A mix of bovine serum, distilled water, and additives is intended to replicate the lubrication conditions in vivo. Weight gain due to fluid absorption during testing is corrected using a load soak station. In this study, three sets of ultrahigh molecular weight polyethylene tibial plateau were tested against highly polished titanium condyles. Test 1 was performed in two different institutions on the same simulator according to the standard ISO 14243-1, using two testing lubricants. Test 2 and test 3 repeated both previous test sections. The wear and load soak rates changed significantly with the lubricant. The wear rate decreased from 16.9 to 7.9 mg weight loss per million cycles when switching from fluid A to fluid B. The weight gain of the load soak specimen submersed in fluid A was 6.1 mg after 5 × 106 cycles, compared with 31.6 mg for the implant in fluid B after the same time period.

Both lubricants were mixed in accordance with ISO 14243 (Implants for surgery - wear of total knee-joint prostheses), suggesting that calf serum should be diluted to 25 ± 2 per cent with deionized water and a protein mass concentration of not less than 17 g/1. The main differences were the type and amount of additives that chemically stabilize the lubricant throughout the test. The results suggest that wear rates can only be compared if exactly the same testing conditions are applied. An agreement on detailed lubricant specifications is desirable.

Intimal hyperplasia (IH) development is a primary cause of failure of reconstructive bypass surgery. While the exact mechanism by which IH initiates and proliferates has yet to be fully elucidated, it is clear that the abnormal haemodynamics present in the downstream graft/artery junction are intrinsic in its development. Mass transport disturbances owing to abnormal haemodynamics have been associated with atherogenesis and it is for this reason that an investigation into transport of platelet-derived growth factor (PDGF), a known promoter of the intimal hyperplastic response, at the downstream graft/artery junction was carried out. A steady flow analysis in a three-dimensional, idealized, downstream graft/artery junction was carried out using commercial computational fluid dynamics software. It was found that there is a two-and-half fold increase in the transport of PDGF to the artery wall at the bed of the junction when compared with an idealized, healthy artery. The presence of secondary flows in the downstream arterial section also leads to large disturbances in mass transport. It was concluded that PDGF transport in the downstream graft/artery junction tends to be highly disturbed and that there may be a role of this disturbance in the initiation and subsequent development of distal anastomotic intimal hyperplasia.

A first approach to in vitro simulation of vascular calcification was elaborated. Vascular calcification was simulated by a slow crystallization of a non-stoichiometric poorly crystallized carbonateapatite from Kokubo's revised simulated body fluid (rSBF) on the surface of a porous pellet made of pure cholesterol. To achieve this, the crystallization experiments were performed under strictly controlled conditions (similar to physiological ones) provided by a constant-composition double-diffusion (CCDD) device. To obtain an even closer match to in vivo conditions, rSBF was enriched by the addition of glucose and bovine serum albumin (BSA) in physiological amounts. Precipitation took place on the surface of cholesterol and the precipitates consisted of poorly crystalline non-stoichiometric, sodium-and magnesium-containing carbonateapatite.