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

The wear debris generated during artificial joint prosthesis service can react with bone tissues to form osteolysis,seriously affecting the life-time of artificial joint prostheses.This paper reviews,summarizes,and analyzes domestic and international research literature on the extraction,characterization,and identification of wear debris from different artificial joint materials,aiming to provide references and feasible ideas for the future construction of a systematic and hierarchical research system for artificial joint wear debris.The main findings are as follows:strong alkali protein degradation test,strong acid protein degradation test,and protease protein degradation test are the commonly used method for extracting artificial joint wear debris,and researchers have clarified the protein degradation mechanisms of these three debris extraction methods.The characterization of wear debris in-vitro and in-vivo is mostly for hip and knee joints,with a small amount involving cervical spine and ankle joints.Studies have shown that the size,quantity,shape,and volume of wear particles are influenced by factors such as joint type,contact area,material selection,and implantation time.Both domestic and international studies have conducted characterization research on wear debris after in-vitro simulation testing,but there is still a lack of wear debris characterization analysis of clinical retrievals in China.Currently,most research is on the recognition of wear debris in the traditional mechanical field,but research on the intelligent recognition of artificial joint wear debris is relatively few,indicating that there is a certain lag in the application of computer technology in the field of artificial joint wear debris recognition.

The wear debris generated during artificial joint prosthesis service can react with bone tissues to form osteolysis,seriously affecting the life-time of artificial joint prostheses.This paper reviews,summarizes,and analyzes domestic and international research literature on the extraction,characterization,and identification of wear debris from different artificial joint materials,aiming to provide references and feasible ideas for the future construction of a systematic and hierarchical research system for artificial joint wear debris.The main findings are as follows:strong alkali protein degradation test,strong acid protein degradation test,and protease protein degradation test are the commonly used method for extracting artificial joint wear debris,and researchers have clarified the protein degradation mechanisms of these three debris extraction methods.The characterization of wear debris in-vitro and in-vivo is mostly for hip and knee joints,with a small amount involving cervical spine and ankle joints.Studies have shown that the size,quantity,shape,and volume of wear particles are influenced by factors such as joint type,contact area,material selection,and implantation time.Both domestic and international studies have conducted characterization research on wear debris after in-vitro simulation testing,but there is still a lack of wear debris characterization analysis of clinical retrievals in China.Currently,most research is on the recognition of wear debris in the traditional mechanical field,but research on the intelligent recognition of artificial joint wear debris is relatively few,indicating that there is a certain lag in the application of computer technology in the field of artificial joint wear debris recognition.

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.