Aseptic loosening is one of the highest causes for revision in total knee arthroplasty (TKA). With growing interest in anatomically aligned (AA) TKA, it is important to understand if this surgical technique affects cemented tibial fixation any differently than mechanical alignment (MA). Previous studies have shown that lipid/marrow infiltration (LMI) during implantation may significantly reduce fixation of tibial implants to bone analogs [1]. This study aims to investigate the effect of surgical alignment on fixation failure load after physiological loading. Alignment specific physiological loading was determined using telemetric tibial implant data from Orthoload [2] and applying it to a validated finite element lower limb model developed by the University of Denver [3]. Two high demand activities were selected for the loading section of this study: step down (SD) and deep knee bend (DKB). Using the lower limb model, hip and ankle external boundary conditions were applied to the ATTUNE® knee system for both MA and AA techniques. The 6 degree of freedom kinetics and kinematics for each activity were then extracted from the model for each alignment type. Mechanical alignment (MA) was considered to be neutral alignment (0° Hip Knee Ankle Angle (HKA), 0° Joint Line (JL)) and AA was chosen to be 3° varus HKA, 5° JL. It is important not to exceed the limits of safety when using AA as such it is noted that DePuy Synthes recommends staying within 3º varus HKA and 3º JL. The use of 5º JL was used in this study to account for surgical variation [Depuy-Synthes surgical technique DSUS/JRC/0617/2179]. Following a similar method described by Maag et al [1] ATTUNE tibial implants were cemented into a bone analog with 2 mL of bone marrow in the distal cavity and an additional reservoir of lipid adjacent to the posterior edge of the implant. Tibial implant constructs were then subjected to intra-operative ROM/stability evaluation, followed by a hyperextension activity until 15 minutes of cement curing time, and finally 3 additional ROM/stability evaluations were performed using an AMTI VIVO simulator. The alignment specific loading parameters were then applied to the tibial implants using an AMTI VIVO simulator. Each sample was subjected to 50,000 DKB cycles and 120,000 SD cycles at 0.8 Hz in series; approximating 2 years of physiological activity. After physiological loading the samples were tested for fixation failure load by axial pull off.Introduction
Methods
Femoral neck impingement occurs clinically in total hip replacements (THR) when the acetabular liner articulates against the neck of a femoral stem prosthesis. This may occur Neck impingement testing per ASTM F2582-14 was carried out on four groups of artificially aged acetabular liners (per ASTM F2003-15) made from GUR 1020 UHMWPE which was re-melted and cross-linked at 7.5 Mrad. Group A (n=3) and B (n=3) consisted of 28mm diameter femoral heads articulating on 28mm ID × 44mm OD acetabular liners. Group C (n=3) and D (n=3) consisted of 40mm diameter femoral heads articulating on lipped 40mm ID × 56mm OD 10° face changing acetabular liners. All acetabular liners were tested in production equivalent shell-fixtures mounted at 0° initial inclination angle. Femoral stems were potted in resin to fit respective simulator test fixtures. Testing was conducted in bovine serum diluted to 18mg/mL protein content supplemented with sodium azide and EDTA. Groups A and C were tested on a Prosim; Groups B and D were tested on an AMTI. Physical examination and coordination measurement machine (CMM) analyses were conducted on all liners pre-test and at 0.2 million cycle intervals to monitor possible failure mechanisms. Testing was conducted for 1.0 million cycles or until failure. An Abaqus/Explicit model was created to investigate relative motions and contact areas resulting from initial impingement kinematics for each test group.Introduction
Method
Implant wear testing is traditionally undertaken using standardized inputs set out by ISO or ASTM. These inputs are based on a single individual performing a single activity with a specific implant. Standardization helps ensure that implants are tested to a known set of parameters from which comparisons may be drawn but it has limitations as patients perform varied activities, with different implant sizes and designs that produce different kinematics/kinetics. In this study, wear performance has been evaluated using gait implant specific loading/kinematics and comparing to a combination deep knee bend (DKB), step down (SD) and gait implant specific loading on cruciate retaining (CR) rotating platform (RP) total knee replacements (TKR). This combination activity profile better replicates patient activities of daily living (ADL). Two sets of three ATTUNE® size 5 right leg CR RP TKRs (DePuy Synthes, Warsaw, IN) were used in a study to evaluate ADL implant wear. Implant specific loading profiles were produced via a validated finite element lower limb model [1] that uses activity data such as gait (K1L_110108_1_86p), SD (K1L_240309_2_144p), and DKB (K9P_2239_0_9_I1) from the Orthoload database [2] to produce external boundary conditions. Each set of components were tested using a VIVO joint simulator (AMTI, Watertown, MA, Figure 1) for a total of 4.5 million cycles (Mcyc). All cycles were conducted at 0.8Hz in force-control with flexion driven in displacement control. Bovine calf serum lubricant was prepared to a total protein concentration of 18g/L and maintained at 37°±2°C. Wear of the tibial inserts was quantified via gravimetric methods per ISO14243–2:2009(E). Polyethylene tibial insert weights were taken prior to testing and every 0.5Mcyc there after which corresponded to serum exchange intervals. The multi-activity test intervals were split into10 loops of 1,250 DKB, 3,000 SD, and 45,750 gait cycles in series. Based on activity data presented by Wimmer et al. the number of cycles per activity and activities used is sufficient for a person that is considered active [3]. A loaded soak control was used to compensate for fluid absorption in wear rate calculations. Wear rates were calculated using linear regression.INTRODUCTION
METHODS
While computational models have been used for many years to contribute to pre-clinical, design phase iterations of total knee replacement implants, the analysis time required has limited the real-time use as required for other applications, such as in patient-specific surgical alignment in the operating room. In this environment, the impact of variation in ligament balance and implant alignment on estimated joint mechanics must be available instantaneously. As neural networks (NN) have shown the ability to appropriately represent dynamic systems, the objective of this preliminary study was to evaluate deep learning to represent the joint level kinetic and kinematic results from a validated finite element lower limb model with varied surgical alignment. External hip and ankle boundary conditions were created for a previously-developed finite element lower limb model [1] for step down (SD), deep knee bend (DKB) and gait to best reproduce in-vivo loading conditions as measured on patients with the Innex knee ( A NN was created utilizing the NN toolbox in MATLAB. Sequence data inputs were produced from the alignment and the external boundary conditions for each activity cycle. Sequence outputs for the model were the 6 degree of freedom kinetics and kinematics, totaling 12 outputs. All data was normalized across the entire data set. Ten percent of the simulation runs were removed at random from the training set to be used for validation, leaving 2220 simulations for training and 244 for validation. A nine-layer bi-long short-term memory (LSTM) NN was created to take advantage of bi-LSTM layers ability to learn from past and future data. Training on the network was undertaken using an RMSprop solver until the root mean square error (RMSE) stopped reducing. Evaluation of NN quality was determined by the RMSE of the validation set.INTRODUCTION
METHODS
A recent submission to ASTM, WK28778 entitled “Standard test method for determination of friction torque and friction factor for hip implants using an anatomical motion hip simulator”, describes a proposal for determining the friction factor of hip implant devices. Determination of a friction factor in an implant bearing couple using a full kinematic walking cycle as described in ISO14242-1 may offer designers and engineers valuable input to improve wear characteristics, minimize torque and improve long term performance of hip implants. The aim of this study was to investigate differences in friction factors between two commercially available polyethylene materials using the procedure proposed. Two polyethylene acetabular liner material test groups were chosen for this study: commercially available Marathon® (A) and AltrX® (B). All liners were machined to current production specifications with an inner diameter of 36mm and an outer diameter of 56mm. Surface roughness (Ra) of the liner inner diameters were measured using contact profilometry in the head-liner contact area, before and after 3Mcyc of wear testing. Liners were soaked in bovine serum for 48 hours prior to testing. Friction factor measurements were taken per ASTM WK28778 prior to, and after wear testing using an external six degrees of freedom load cell (ATI Industrial Automation) and a reduced maximum vertical load of 1900N. Friction factor and wear testing was conducted in bovine serum (18mg/mL total protein concentration) supplemented with 0.056% sodium azide (preservative) and 5.56mM EDTA (calcium stabilizer) on a 12-station AMTI (Watertown, MA) ADL hip simulator with load soak controls per ISO 14242-1:2014(E). The liners were removed from the machine, cleaned and gravimetric wear determined per ISO 14242-2:2000(E) every 0.5 million cycles (MCyc) through a total of 3Mcyc to evaluate wear.Introduction and Aims
Methods
Aseptic loosening of total knee replacements is a leading cause for revision. It is known that micromotion has an influence on the loosening of cemented implants though it is not yet well understood what the effect of repeated physiological loading has on the micromotion between implants and cement mantle. This study aims to investigate effect of physiological loading on the stability of tibial implants previously subjected to simulated intra-operative lipid/marrow infiltration. Three commercially available fixed bearing tibial implant designs were investigated in this study: ATTUNE®, PFC SIGMA® CoCr, ATTUNE® S+. The implant designs were first prepared using a LMI implantation process. Following the method described by Maag et al tibial implants were cemented in a bone analog with 2 mL of bone marrow in the distal cavity and an additional reservoir of lipid adjacent to the posterior edge of the implant. The samples were subjected to intra- operative range of motion (ROM)/stability evaluation using an AMTI VIVO simulator, then a hyperextension activity until 15 minutes of cement cure time, and finally 3 additional ROM/stability evaluations were performed. Implant specific physiological loading was determined using telemetric tibial implant data from Orthoload and applying it to a validated FE lower limb model developed by the University of Denver. Two high demand activities were selected for the loading section of this study: step down (SD) and deep knee bend (DKB). Using the above model, 6 degree of freedom kinetics and kinematics for each activity was determined for each posterior stabilized implant design. Prior to loading, the 3-D motion between tibial implant and bone analog (micromotion) was measured using an ARAMIS Digital Image Correlation (DIC) system. Measurement was taken during the simulated DKB at 0.25Hz using an AMTI VIVO simulator while the DIC system captured images at a frame rate of 10Hz. The GOM software calculated the distance between reference point markers applied to the posterior implant and foam bone. A Matlab program calculated maximum micromotion within each DKB cycle and averaged that value across five cycles. The implant specific loading parameters were then applied to the three tibial implant designs. Using an AMTI VIVO simulator each sample was subjected to 50,000 DKB and 120,000 SD cycles at 0.8Hz in series; equating to approximately 2 years of physiological activity. Following loading, micromotion was measured using the same method as above.Introduction
Methods
The wear rate of Ultra High Molecular Weight Polyethylene (UHMWPE) in joint replacements has been correlated to both contact area and contact stress in the literature, [1], [2]. In both publications and our experiment, UHMWPE articulated with a polished surface of cobalt-chromium alloy was evaluated using a Pin-On-Disk (POD) apparatus (AMTI) implementing bi-directional movement. In publication [1], volumetric wear was independent of normal load and dependent upon increasing contact area. The results demonstrated that increasing contact stress In our experiment, the contact area was dependent on textured POD Pin 390 (T390) which had low wear [3]. T390 reduced the normal POD contact area from 71 mm2 to 8.26 mm2. Hydroxylapatite (HA) particles were introduced to the serum to simulate third body wear debris. We hypothesized that the normal POD Pins would have greater wear rates than the textured POD Pins. A measurement of 0.14 mg HA particles per 250 mL of serum was used for each test 0.33 million cycles. The GUR 1020 resin XLK POD Pins were gamma irradiated to 50 kGy in a vacuum package and then remelted. Three (3) T390 POD pins and nine (9) untextured XLK POD Pins were used. Three untextured XLK POD Pins were tested against three T390 POD pins. The other six (6) untextured XLK POD Pins were used as soak controls. Each pin articulated against a polished, high carbon wrought CoCr metal alloy counterface (ASTM F1537; diameter = 38.1 mm; thickness = 12.7 mm). Wear rate tests were for 1.98 million cycles. In order to perform the t-test analysis, the wear rates for each pin were given by the slope of the linear regression line through the individual data points (cycle count, cumulative wear), excluding the (0, 0) point.Statement of Purpose:
Methods:
