Validation of the Finite Element Model versus Biomechanical Assessments of Dental Implants and Total Knee Replacements.

Computer modeling and simulation (CM&S) technology is widely used in the medical device industry due to its advantages such as reducing testing time and costs. However, the developer's parameter settings during the modeling and simulation process can have a significant impact on the results. This study developed a test model for the rotational shear strength of dental implants and the constraint force of total knee replacements based on CM&S technology and proposes ideal parameters to ensure reliability. For dental implants, the load area and sliding contact conditions were considered, and for total knee replacements, the friction coefficient, medial-lateral displacement, valgus-varus rotation, and elastic modulus were considered. By comparing the simulation results and mechanical tests, boundary conditions with an error rate of less than 1.5% were selected. When a jig (gripper and collector) was applied with the same boundary conditions, an error rate of 48~22% occurred; otherwise, it was confirmed that the error rate was within 10~0.2%. The FE model was verified with an error of 2.49 to 3% compared to the mechanical test. The friction coefficient variable had the greatest influence on the results, accounting for 10 to 13%, and it was confirmed that valgus-varus rotation had a greater influence on the results than medial-lateral displacement. Relatively, the elastic modulus of the insert had the least effect on the results. These research results are expected to make CM&S techniques useful as a medical device digital development tool (M3DT) in the development of total knee replacements and dental implants.

Biomechanical and Biological Assessment of Polyglycelrolsebacate-Coupled Implant with Shape Memory Effect for Treating Osteoporotic Fractures.

Poly(glycerol sebacate) is a biocompatible elastomer that has gained increasing attention as a potential biomaterial for tissue engineering applications. In particular, PGS is capable of providing shape memory effects and allows for a free form, which can remember the original shape and obtain a temporary shape under melting point and then can recover its original shape at body temperature. Because these properties can easily produce customized shapes, PGS is being coupled with implants to offer improved fixation and maintenance of implants for fractures of osteoporosis bone. Herein, this study fabricated the OP implant with a PGS membrane and investigated the potential of this coupling. Material properties were characterized and compared with various PGS membranes to assess features such as control of curing temperature, curing time, and washing time. Based on the ISO 10993-5 standard, in vitro cell culture studies with C2C12 cells confirmed that the OP implant coupled with PGS membrane showed biocompatibility and biomechanical experiments indicated significantly increased pullout strength and maintenance. It is believed that this multifunctional OP implant will be useful for bone tissue engineering applications.