Abstract
Wear is an important factor in the long term success of total knee arthroplasty. Therefore, wear testing methods and machines become a standard in research and implant development. These methods are based on two simulation concepts which are defined in standards ISO 14243-1 and 14243-3. The difference in both concepts is the control mode. One is force controlled while the other has a displacement controlled concept.
The aim of this study was to compare the mechanical stresses within the different ISO concepts. Furthermore the force controlled ISO was updated in the year 2009 and should be compared with the older which was developed in 2001.
A finite element model based on the different ISO standards was developed. A validation calculated with kinematic profile data of the same implant (Aesculap, Columbus CR) in an experimental wear test setup (Endolap GmbH) was done. Based on this model all three different ISO standards were calculated and analysed.
Validation results showed Pearson correlation for anterior posterior movement of 0.3 and for internal external rotation 0.9. Two main pressure maximums were present in ISO 14243-1:2001 (force controlled) with 17.9 MPa and 13.5 MPa for 13 % and 48 % of the gait cycle. In contrast ISO 14243-1:2009 (force controlled) showed three pressure maximums of 18.5 MPa (13 % of gait cycle), 16.4 MPa (48 % of gait cycle) and 13.2 MPa (75 % of gait cycle). The displacement controlled ISO (14243-3:2014) showed two pressure maximums of 16.0 MPa (13 % of gait cycle) and 17.2 MPa (48 % of gait cycle).
The adapted force controlled ISO of the year 2009 showed higher mechanical stress during gait cycle which also might lead to higher wear rates. The displacement controlled ISO leads to higher mechanical stress because of the constraint at the end of the stance phase of the gait cycle. Future studies should analyse different inlay designs within these ISO standards.
