TY - JOUR
T1 - Extensive risk analysis of mechanical failure for an epiphyseal hip prothesis
T2 - A combined numerical-experimental approach
AU - Martelli, Saulo
AU - Taddei, Fulvia
AU - Cristofolini, Luca
AU - Gill, Harinderjit
AU - Viceconti, Marco
PY - 2011/2/1
Y1 - 2011/2/1
N2 - There has been recent renewed interest in proximal femur epiphyseal replacement as an alternative to conventional total hip replacement. In many branches of engineering, risk analysis has proved to be an efficient tool for avoiding premature failures of innovative devices. An extensive risk analysis procedure has been developed for epiphyseal hip prostheses and the predictions of this method have been compared to the known clinical outcomes of a well-established contemporary design, namely hip resurfacing devices. Clinical scenarios leading to revision (i.e. loosening, neck fracture and failure of the prosthetic component) were associated with potential failure modes (i.e. overload, fatigue, wear, fibrotic tissue differentiation and bone remodelling). Driving parameters of the corresponding failure mode were identified together with their safe thresholds. For each failure mode, a failure criterion was identified and studied under the most relevant physiological loading conditions. All failure modes were investigated with the most suitable investigation tool, either numerical or experimental. Results showed a low risk for each failure scenario either in the immediate postoperative period or in the long term. These findings are in agreement with those reported by the majority of clinical studies for correctly implanted devices. Although further work is needed to confirm the predictions of this method, it was concluded that the proposed risk analysis procedure has the potential to increase the efficacy of preclinical validation protocols for new epiphyseal replacement devices.
AB - There has been recent renewed interest in proximal femur epiphyseal replacement as an alternative to conventional total hip replacement. In many branches of engineering, risk analysis has proved to be an efficient tool for avoiding premature failures of innovative devices. An extensive risk analysis procedure has been developed for epiphyseal hip prostheses and the predictions of this method have been compared to the known clinical outcomes of a well-established contemporary design, namely hip resurfacing devices. Clinical scenarios leading to revision (i.e. loosening, neck fracture and failure of the prosthetic component) were associated with potential failure modes (i.e. overload, fatigue, wear, fibrotic tissue differentiation and bone remodelling). Driving parameters of the corresponding failure mode were identified together with their safe thresholds. For each failure mode, a failure criterion was identified and studied under the most relevant physiological loading conditions. All failure modes were investigated with the most suitable investigation tool, either numerical or experimental. Results showed a low risk for each failure scenario either in the immediate postoperative period or in the long term. These findings are in agreement with those reported by the majority of clinical studies for correctly implanted devices. Although further work is needed to confirm the predictions of this method, it was concluded that the proposed risk analysis procedure has the potential to increase the efficacy of preclinical validation protocols for new epiphyseal replacement devices.
KW - epiphyseal prosthesis
KW - finite element model
KW - hip biomechanics
KW - in vitro simulation
KW - preclinical validation
KW - risk analysis
UR - http://www.scopus.com/inward/record.url?scp=79551510102&partnerID=8YFLogxK
U2 - 10.1243/09544119JEIM728
DO - 10.1243/09544119JEIM728
M3 - Article
VL - 225
SP - 126
EP - 140
JO - Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine
JF - Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine
SN - 0954-4119
IS - 2
ER -