Compared with total knee arthroplasty, unicondylar knee replacement has the advantage of preserving the knee tissue structure and motor function to the greatest extent. Pre-clinical in-vitro test is an important tool to evaluate the safety and effectiveness of unicondylar knee prostheses, and it is also a key focus of the product registration process. Through collection, comparison, and analysis of current regulations, technical standards, guidelines, and related research literature, this paper expounds on the relevant research methods for the pre-clinical in-vitrotesting of unicondylar knee prostheses. At the same time, in conjunction with current evaluation requirements and experience, the study discusses the focus of pre-clinical performance research for unicondylar knee prostheses during the registration process to clarify the performance evaluation requirements of this product category. This aims to provide a reference for the pre-clinical performance research of unicondylar knee prostheses and to standardize industry testing standards.
Knee Prosthesis ; Arthroplasty, Replacement, Knee ; Humans ; Prosthesis Design ; Materials Testing

BACKGROUND:Hyaluronan with special linear macromolecular structure and rheologic property has good biocompatibility and becomes a signal matter of the cel surface, which possesses a promising application potential in tissue-engineering field. OBJECTIVE:To review the research progress in medical hyaluronan composites. METHODS:Related literatures concerning preparation, safety evaluation and clinical trials of hyaluronan composites were extensively reviewed and comprehensively analyzed in the three folowing aspects: cartilage scaffold, cornea scaffold and submucous bulking agent. RESULTS AND CONCLUSION:The hyaluronan composite has a potential use in cartilage scaffold and cornea scaffold as its suitable porosity and pore size, biomimetic three-dimensional microstructure, excelent physical and chemical property and biological property. The hyaluronan composite as a bulking agent has been applied clinicaly, and results from some clinical trials have shown that the composite used as bulking agent has the problems about low efficacy and complications, which need to do further improvement. More researches are needed in product design, evaluation of performance and safety for expending and optimizing the clinical applications of the hyaluronan composite.