In vitro wear analysis of a new type of tibial liner for artificial knee joint
10.3969/j.issn.1672-8270.2024.09.032
- VernacularTitle:一种新型人工膝关节胫骨衬垫的体外磨损分析
- Author:
Shitong YAN
1
;
Jianjun WANG
;
Jian SU
Author Information
1. 北京市医疗器械检验研究院材料二室 北京 101111
- Keywords:
Knee prosthesis;
In vitro wear;
Wear rate;
Wear volume;
Wear debris analysis
- From:
China Medical Equipment
2024;21(9):171-177
- CountryChina
- Language:Chinese
-
Abstract:
In vitro wear tests were conducted on knee tibial liner manufactured from a new highly cross-linked polyethylene material(XLPE-DG)with dodecyl gallate.The characteristics(quantity,size and shape)of wear mass loss(wear volume),wear rate and wear particles were studied,and the wear performance in different wear stages was analyzed,so as to provide data support for the research and development and clinical application of domestic medical polyethylene materials.In accordance with the International Organization for Standardization(ISO)14243-1 and 14243-2 standard methods,4 total knee arthroplasty prostheses were selected as test samples(3 in the test group and 1 in the control group).The lubricant in the test was calf serum,and the XLPE-DG liner was tested for cyclic wear using a knee joint simulator.The wear volume and the wear rate after 1 million cycles(1 Mc),3 million cycles(3 Mc),and 5 million cycles(5 Mc)were calculated respectively.The abrasive debris images obtained by the scanning electron microscope(SEM)was analyzed by using image analysis software to analyze the characteristics of the debris of the wear debris(number,size and shape).After passing the 5 Mc wear test,the wear amount of XLPE-DG liner was(23.86±0.75)mg,with a corresponding wear rate of(4.39±0.75)mg/Mc and the wear amount during the 3-5 Mc stage was similar to that of the 1-3 Mc stage(8.79 mg vs.8.74 mg).The number of wear debris decreased with the increase of the number of wear times.The average value of the equivalent circular area diameter(ECD)of the wear debris of XLPE-DG liner after 5 Mc was 0.13 μm(minimum value 0.04 μm,maximum value 0.8 μm),and the average ECD of 77.11%±6.89%particles was<0.2 μm,the average value of ECD decreased with the increase of the number of wear times.The average value of the aspect ratio(AR)of the liner after 5 Mc wear was 2.8(minimum 1.0,maximum 9.9),of which 77.9%had an AR value of<4 and the particles are mainly round.The XLPE-DG liner demonstrated excellent wear resistance and can reduce the risk of periprosthetic inflammation,osteolysis,and prosthetic loosening in clinical applications,and have good clinical application potential.
