A risk and credibility framework for in silico clinical trials of medical devices.

Background And Objective: The use of in silico clinical trials (ISCTs) to generate clinically-relevant data on new medical devices is an emerging area of regulatory research. Interest in ISCTs stems from recognized challenges in acquiring sufficient clinical data and the continued maturation of in silico technologies. There is currently no guidance in place for evaluating the credibility of ISCT applications.

Identifying the patient harms to include in an in silico clinical trial.

Background And Objective: Clinical trials represent a crucial step in the development and approval of medical devices. These trials involve evaluating the safety and efficacy of the device in a controlled setting with human subjects. However, traditional clinical trials can be expensive, time-consuming, and ethically challenging.

Computational Model Validation of Contact Mechanics in Total Ankle Arthroplasty.

Revision rates in total ankle arthroplasty (TAA) are nearly double compared with hip or knee arthroplasty procedures. Contact mechanics for metal-polyethylene articulation in TAA is critical due to the reduced size of the implant and higher expected load, compared with a hip or knee joint. This study was focused on developing a validated computational model to predict contact area in a polyethylene tibial bearing articulating with a metallic talar component in a bicondylar TAA design.

Wear, delamination, and fatigue resistance of melt-annealed highly crosslinked UHMWPE cruciate-retaining knee inserts under activities of daily living.

The wear, delamination, and fatigue resistance of artificially aged gamma irradiation-sterilized conventional polyethylene (CPE) and gas-plasma-sterilized melt-annealed highly crosslinked polyethylene tibial inserts (HXPE) were compared. Six CPE and 12 HXPE (six irradiated at 58 kGy and six at 72 kGy) left knee inserts were wear tested for 5.5 million cycles (Mc) under loads and motions that mimic activities of daily living, such as walking, chair rise, stair ascent, and deep squatting.

Sensitivity of finite helical axis parameters to temporally varying realistic motion utilizing an idealized knee model.

Various uses of the screw or helical axis have previously been reported in the literature in an attempt to quantify the complex displacements and coupled rotations of in vivo human knee kinematics. Multiple methods have been used by previous authors to calculate the axis parameters, and it has been theorized that the mathematical stability and accuracy of the finite helical axis (FHA) is highly dependent on experimental variability and rotation increment spacing between axis calculations. Previous research has not addressed the sensitivity of the FHA for true in vivo data collection, as required for gait laboratory analysis.