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.

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.

Evaluation of Total Ankle Arthroplasty Using Highly Crosslinked Ultrahigh-Molecular-Weight Polyethylene Subjected to Physiological Loading.

Background: Highly crosslinked polyethylene (HXLPE) was developed for its superior wear properties in comparison to conventional polyethylene (CPE). Concern over fatigue resistance has prevented widespread adoption of HXLPE for use in total ankle arthroplasty (TAA). The aim of this study was to determine whether HXLPE has sufficient fatigue strength for total ankle arthroplasty under simulated physiologically relevant motion profiles and loading in the ankle.

Impact of Modeling Assumptions on Stability Predictions in Reverse Total Shoulder Arthroplasty.

Reverse total shoulder arthroplasty (rTSA) is commonly used in the shoulder replacement surgeries for the relief of pain and to restore function, in patients with grossly deficient rotator cuff. Primary instability due to glenoid loosening is one of the critical complications of rTSA; the implants are designed and implanted such that the motion between the glenoid baseplate and underlying bone is minimized to facilitate adequate primary fixation. Finite element analysis (FEA) is commonly used to simulate the test setup per ASTM F2028-14 for comparing micromotion between designs or configurations to study the pre-clinical indications for stability.

Metatarsal Loading During Gait-A Musculoskeletal Analysis.

Detailed knowledge of the loading conditions within the human body is essential for the development and optimization of treatments for disorders and injuries of the musculoskeletal system. While loads in the major joints of the lower limb have been the subject of extensive study, relatively little is known about the forces applied to the individual bones of the foot. The objective of this study was to use a detailed musculoskeletal model to compute the loads applied to the metatarsal bones during gait across several healthy subjects.

Repair of periprosthetic pelvis defects with porous metal implants: a finite element study.

Periacetabular osteolysis is a potentially difficult surgical challenge, which can often drive the choice of reconstruction methods used in revision hip replacement. For smaller defects, impaction of bone grafts may be sufficient, but larger defects can require filler materials that provide structural support in addition to filling a void. This study utilized finite element analysis (FEA) to examine the state of stress in periprosthetic pelvic bone when subjected to a stair-climbing load and in the presence of two simulated defects, to show the effect of implanting a defect repair implant fabricated from Trabecular Metal.