In Vivo Kinematic Analysis of Bicruciate-retaining Total Knee Arthroplasty Focused on Function of the ACL

Background: The utility of a bi-cruciate retaining total knee arthroplasty (BCR-TKA) is uncertain. In this study, we performed an in vivo kinematic analysis of squat motion on level ground and on a downward slope in patients treated with BCR-TKA to examine the value of anterior cruciate ligament (ACL) preservation.Methods: The subjects were ten valgus knees that underwent TKA (BCR: 5 knees, CR: 5 knees) at our hospital. We evaluated in vivo kinematics of the knee using fluoroscopy and investigated the femoral component translation relative to the tibial component from extension to maximum flexion, and the rotation angle between the components under the two conditions. Statistical analysis was conducted by Mann-Whitney U test to compare the rotational angle, the location of lateral and medial contact points per flexion angle. Differences in these parameters between the BCR and CR groups across the flexion angles were compared by repeated measures ANOVA.Results: Rotation of the femoral component to the tibial component occurred gradually as flexion continued. On level ground, lateral rotation at 0° to 120° flexion was 14.5±1.95° in the BCR group and 7.9±0.47° in the CR group. Medial translation was 4.1±1.73mm in the BCR group and 2.5±1.64mm in the CR group, and lateral translation was 13.2±1.6mm in the BCR group and 7.1±1.74mm in the CR group. On a forward slope, lateral rotation was 12.7±1.45° in the BCR group and 7.57±0.47° in the CR group. Medial translation was 5.87±1.78mm in the BCR and 2.9±0.81mm in the CR, and lateral translation was 13.6±1.84mm in the BCR and 7.4±0.96mm in the CR.Conclusion: An in vivo kinetics analysis of deep flexion motion was conducted on level ground and on a forward slope to stress the ACL. Under both conditions, kinetics close to screw home movement were found in the BCR group and rotation was significantly larger than that in the CR group. The medial contact point between components was located significantly more anterior in the BCR group. In conclusion, BCR-TKA was found to have in vivo kinetics close to those of a normal knee, in comparison with CR-TKA.

An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence

The aim of this study was to develop a new in vitro–in vivo simulation (IVIVS) approach in order to predict the outcome of a bioequivalence study. The predictability of the IVIVS procedure was evaluated through its application in the development process of a new generic product of amlodipine/irbesartan/hydrochlorothiazide. The developed IVIVS methodology is composed of three parts: (a) mathematical description of in vitro dissolution profiles, (b) mathematical description of in vivo kinetics, and (c) development of joint in vitro–in vivo simulations. The entire programming was done in MATLAB® and all created scripts were validated through other software. The IVIVS approach can be implemented for any number of subjects, clinical design, variability and can be repeated for thousands of times using Monte Carlo techniques. The probability of success of each scenario is recorded and finally, an overall assessment is made in order to select the most suitable batch. Alternatively, if the IVIVS shows reduced probability of BE success, the R&D department is advised to reformulate the product. In this study, the IVIVS approach predicted successfully the BE outcome of the three drugs. During the development of generics, the IVIVS approach can save time and expenses.