Comparison of ISO standard and TKR patient axial force profiles during the stance phase of gait.

Preclinical endurance testing of total knee replacements (TKRs) is performed using International Organization for Standardization (ISO) load and motion protocols. The standards are based on data from normal subjects and may not sufficiently mimic in vivo implant conditions. In this study, a mathematical model was used to calculate the axial force profile of 30 TKR patients with two current implant types, 22 with NexGen and eight with Miller-Galante II Cruciate-Retaining TKRs, and statistically compare the axial force specified by the ISO standard to the TKR patients. Significant differences were found between the axial forces of both groups of TKR patients and the ISO standard at local maxima and minima points in the first half of stance. The force impulse (area under the axial force curve, representing cumulative loading) was smaller for the ISO standard than the TKR patients, but only for those with NexGen implants. Waveform analysis using the coefficient of multiple correlation showed that the ISO and TKR patient axial force profiles were similar. The combined effect of ISO standard compressive load and motion differences from TKR patients could explain some of the differences between the wear scars on retrieved tibial components and those tested in total joint simulators.

Backside wear of tibial polyethylene components is affected by gait pattern: A knee simulator study using rare earth tracer technology.

The aim of this study was to determine the effect of two in-vivo-determined gait patterns, one with low and one with high anteroposterior (AP) motion, on total and backside polyethylene insert wear in comparison with the ISO (International Organization for Standardization) standard 14243-3. In order to differentiate and accurately quantify topside and backside wear, a novel technique was employed where different lanthanide tracers were incorporated into the polyethylene during manufacture. Wear particle analysis was conducted following established protocols. For all tested liners and motion protocols, the chemically calculated wear rates correlated closely with gravimetrically determined wear. Both in vivo motion groups displayed higher wear rates than the ISO group following the order of the AP motion amplitudes. Backside wear for ISO constituted 2.76% ± 0.90% (mean ± SE) of the total wear, increasing significantly to 15.8% ± 3.2% for the low AP and further increasing to 19.3% ± 0.95% for the high AP motion protocol. The mean wear particle sizes were under 200 nm for all three motion patterns, being largest for the protocol with high AP motion. Particle release from the low and high AP gait patterns was 1.9 to 2.8 times that from the ISO protocol. Testing for the proportion of backside wear across various activities of daily living should be an important consideration in evaluating knee prostheses wear.

Imaging protein deposits on contact lens materials.

PURPOSE: The majority of studies investigating protein deposition on contact lens materials require that the deposit of interest be removed, potentially resulting in erroneous results if some proteins are not removed adequately. The purpose of this study was to investigate the use of in situ imaging methods to examine protein deposition on conventional poly(2-hydroxyethyl methacrylate) (polyHEMA)-based and silicone hydrogel contact lens materials. METHODS: Six silicone hydrogel and five polyHEMA-based hydrogel contact lens materials were examined by Atomic Force Microscopy (AFM) and/or Scanning Electron Microscopy (SEM) techniques, after being deposited with proteins in an in vitro model. AFM studies examined lenses deposited solely with lysozyme at approximate physiological concentrations and SEM studies were conducted on lenses exposed to a dilute mixture of lysozyme and albumin-conjugated gold spheres. RESULTS: AFM studies demonstrated that the lens materials had markedly differing surface topographies. SEM results showed that galyfilcon A and balafilcon A lenses deposited both lysozyme and albumin in relatively large aggregates, as compared with lotrafilcon A and B, in which the proteins were deposited in a more evenly spread, monolayer formation. Polymacon lenses deposited more protein than any of the silicone hydrogel materials and much of the protein was aggregated together. AFM data indicated that balafilcon A, lotrafilcon A and polymacon deposited lysozyme in a similar manner, with very little lysozyme being deposited in discrete areas. Galyfilcon A behaved very differently, with the lysozyme exhibiting both aggregates as well as string-like formations over the lens surface. CONCLUSIONS: Imaging techniques that allow proteins to be examined in situ show much promise for determining the extent and physical characterization of protein on contact lens materials. These techniques indicate that the pattern of deposition of proteins onto silicone hydrogel contact lens materials differs between materials, depending upon their bulk and surface composition.

Variability of TKR knee kinematics and relationship with gait kinetics: implications for total knee wear.

Several factors, including compressive load and knee kinematics, have been shown to influence wear. External knee moments (a surrogate for load) have recently been correlated with the medial and lateral wear scar areas of an unconstrained, PCL retaining knee design. Therefore, the purpose of this study was to determine whether differences in kinetics during level walking are accompanied by specific differences in relative knee kinematics. Thirty TKR patients were gait tested using the point cluster technique to obtain 3D motions of the knee. External knee moments were calculated from ground reaction forces recorded with a multicomponent force plate. The subjects were separated into two distinct anteroposterior (AP) motion categories: a low motion group and a high motion group. Similarly, the low and high motion groups for internal-external (IE) rotation were also identified. For the IE motion, there was no significant difference between the transverse internal rotation moments between the two IE motion groups. However for the AP motion groups, a higher external peak flexion moment was found for the group displaying less AP motion. These observations suggest that subjects with higher joint moments execute smaller ranges of AP motion and thus are likely to incur less wear.

Kinematic evaluation of cruciate-retaining total knee replacement patients during level walking: a comparison with the displacement-controlled ISO standard.

Differences between wear-scar features of simulator-tested and retrieved tibial total knee replacement (TKR) liners have been reported. This disagreement may result from differences between in vivo kinematic profiles and those defined by the International Organization for Standardization (ISO). The purpose of this study was to determine the knee kinematics of a TKR subject group during level walking and compare them with the motion profiles defined by the ISO standard for a displacement-controlled knee wear testing simulator. Twenty-nine patients with a posterior cruciate ligament-retaining TKR design were gait tested using the point cluster technique to obtain flexion-extension (FE) rotation, anterior-posterior (AP) translation and internal-external (IE) rotation knee motions during a complete cycle of level walking. Relative ranges of motion and timing of key points within the in vivo motion data were compared against the same ranges and same key points from the input profiles of the displacement-controlled wear testing standard ISO14243-3. The subjects exhibited a FE pattern similar to ISO, with an insignificant difference in range of FE rotation from midstance to terminal stance. However, the subjects had a significantly higher range of knee flexion from terminal stance into swing. The subjects also exhibited a phase delay for the entire gait cycle. For AP translation, the standard profile had statistically significant lower magnitudes than seen in vivo. Opposite pattern of AP motion was also apparent from midstance and swing. Similarly, ISO specified a smaller IE total range of rotation with a motion pattern in complete opposition to that seen in vivo. In conclusion, significant differences were found in both the magnitudes and pattern of in vivo motion compared with ISO.