Wear simulation in total knee arthroplasty (TKA) is currently based on the most frequent activity – level walking. A decade ago multi-station knee wear simulators were introduced leading to optimisations of TKA designs, component surface finish and bearing materials. One major limitation is that current wear testing is mainly focused on abrasive-adhesive wear and in vitro testing does not reflect “delamination” as an essential clinical failure mode. The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation. A cruciate retaining fixed bearing TKA design (Columbus CR) with artificially aged polyethylene knee bearings (irradiation 30±2 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities with high flexion (2×40% stairs up and down, 10% level walking, 8% chair raising, 2% deep squatting) were applied for 5 million cycles. The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes.Background
Methods
Highly cross-linked polyethylene (XLPE) inserts have shown significant improvements in decreasing wear and osteolysis in total hip arthroplasty [1]. In contrast to that, XLPE has not shown to reduce wear or aseptic loosening in total knee arthroplasty [2,3,4]. One major limitation is that current wear testing in vitro is mainly focused on abrasive-adhesive wear due to level walking test conditions and does not reflect “delamination” as an essential clinical failure mode [5,6]. The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation. A cruciate retaining fixed bearing TKA design (Columbus® CR) with artificially aged polyethylene knee bearings (irradiation 30 & 50 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities measured by Bergmann et al. [7] in vivo, were applied for 5 million knee wear cycles in a combination of 40% stairs up, 40 % stairs down, 10% level walking, 8% chair raising and 2% deep squatting with up to 100° flexion [8] (Fig. 1). The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes.INTRODUCTION
MATERIALS & METHODS
Realistic knee contact forces and moments are needed for testing implant wear, fatigue and static strength, for analysing strains and remodelling at interfaces, as ‘gold standard’ for analytical musculo-skeletal models, or as input for finite element models. ISO 14243 defines the loading conditions for wear tests, but the defined loads from walking are based on very old data. Therefore we compared the ISO loads with data obtained from instrumented tibial components with telemetric data transmission. Cruciate ligaments sacrificing total knee implants (Innex FIXUC, Zimmer) were equipped with inductively powered electronics and strain gauges to measure 6 force and moment components acting on the tibial component Loads were measured in 8 subjects (70 years Ø) during 10–20 repeated cycles of free walking at about 4 km/h. For each subject the load components were normalized to 75 kg body weight (BW) and averaged Introduction
Methods
Accurate in vivo knee joint contact forces are required for joint simulator protocols and finite element models during the development and testing of total knee replacements (Varadarajan et al., 2008.) More accurate knowledge of knee joint contact forces during high flexion activities may lead to safer high flexion implant designs, better understanding of wear mechanisms, and prevention of complications such as aseptic loosening (Komistek et al., 2005.) High flexion is essential for lifestyle and cultural activities in the developing world, as well as in Western cultures, including ground-level tasks and chores, prayer, leisure, and toileting (Hemmerich et al., 2006.) In vivo tibial loads have been reported while kneeling; but only while the subject was at rest in the kneeling position (Zhao et al., 2007), meaning that the loads were submaximal due to muscle relaxation and thigh-calf contact support. The objective of this study was to report the in vivo loads experienced during high flexion activities and to determine how closely the measured axial joint contact forces can be estimated using a simple, non-invasive model. It provides unique data to better interpret non-invasively determined joint-contact forces, as well as directly measured tiobiofemoral joint contact force data for two subjects. Two subjects with instrumented tibial implants performed kneeling and deep knee bend activities. Two sets of trials were carried out for each activity. During the first set, an electromagnetic tracking system and two force plates were used to record lower limb kinematics and ground reaction forces under the foot and under the knee when it was on the ground. In the second set, three-dimensional joint contact forces were directly measured in vivo via instrumented tibial implants (Heinlein et al., 2007.) The measured axial joint contact forces were compared to estimates from a non-invasive joint contact force model (Smith et al., 2008.) The maximum mean axial forces measured during the deep knee bend were 24.2 N/kg at 78.2° flexion (subject A) and 31.1 N/kg at 63.5° flexion (subject B) during the deep knee bend (Figure 1.) During the kneeling activity, the maximum mean axial force measured was 29.8 N/kg at 86.8° flexion (subject B.) While the general shapes of the model-estimated curves were similar to the directly measured curves, the axial joint contact force model underestimated the measured contact forces by 7.0 N/kg on average (Figure 2.) The most likely contributor to this underestimation is the lack of co-contraction in the model. The study protocol was limited in that data could not be simultaneously collected due to electromagnetic interference between the motion tracking system and the inductively powered instrumented tibial component. Because skin-mounted markers were used, kinematics may be affected by skin motion artefacts. Despite these limitations, this study presents valuable information that will advance the development of high flexion total knee replacements. The study provides in vivo measurements and non-invasive estimates of joint contact forces during high flexion activities that can be used for joint simulator protocols and finite element modeling.
