Finite element analysis to predict short and medium-term performance of the anatomical Comprehensive® Total Shoulder System.

BACKGROUND: The number of Total Shoulder Arthroplasties (TSA) has increased in these last years with significant increase of clinical success. However, glenoid component loosening remains the most common cause of failure. OBJECTIVE: In this study we evaluated the critical conditions to predict short and medium-term performance of the uncemented anatomical Comprehensive® Total Shoulder System using a finite element model that was validated experimentally. METHODS: The finite element models of an implanted shoulder analysed included total shoulder components with pegs. The models were simulated in 3 phases of adduction: 45°, 60° and 90° to determine the most critical situation. Two different bone-implant fixation conditions were considered: post-surgery and medium term (2 years). RESULTS: These show that the critical condition is for the shoulder in 90° adduction were the highest contact stress (70 MPa) was observed in the glenoid component. Relatively to the interface implant-bone strains, the maximum (-16000 µÎµ) was observed for the short-term in the lateral region of the humerus. The highest micromotions were observed in the central fixation post of the glenoid component, ranging from 20 to 25 µm, and 325 µm in the lateral plane of the humeral component. CONCLUSION: The predicted results are in accordance with clinical studies published and micromotions of the humeral component can be used to predict loosening and to differentiate shoulder implant designs.

Challenges of pre-clinical testing in orthopedic implant development.

The market for orthopedic implants is growing rapidly with the increasing prevalence of orthopedic diseases in an aging society. Different designs and materials have been developed over the years and have, in general, shown excellent results in pre-clinical testing. However, there have been incidences of serious complications when novel implants or materials are put into clinical use, with some well-known cases being metallosis in patients implanted with metal-on-metal hip replacements and osteolysis from polyethylene wear debris generated in hip and knee joint replacements. Unforeseen factors related to new designs, materials and surgical techniques can lead to different outcomes for pre-clinical testing and clinical use. While often an excellent indicator of a device's performance in clinical settings, pre-clinical testing does sometime fail to predict critical flaws in implant development. This article aims to explore the gaps in the current approach to testing. The ISO international standard of pre-clinical testing should be modified to more adequately capture actual clinical use of the implant and simulate daily activities. This article will also introduce modern methods for implant development, such as FEM, 3D printing and computer-aided orthopedic surgery, which can be widely applied to improve pre-clinical testing procedures and reduce the incidence of surgical malalignment by analyzing biomechanical performance, planning surgical procedure and providing surgical guide.