Pre-clinical validation of joint prostheses: a systematic approach.
The pre-clinical validation of new joint prostheses is an important step in the development process of a new implant design. The high success rate of modern prostheses makes it very difficult to ensure that new designs will exhibit significant improvements combined with a risk of failure as low as that of the designs currently in use. This situation requires a systematic re-thinking of the pre-clinical validation protocols. We advocate that a careful combination of risk analysis, experimental and numerical modelling, and the use of statistical finite element analysis to generalize the results to a simulated population, can provide the level of confidence required by class 3 devices as the joint prostheses recently became. The proposed approach is illustrated using the validation of a cemented epiphyseal stem as an example.
Viceconti
Marco
M
Laboratorio di Tecnologia Medica, Istituti Ortopedici Rizzoli, Italy. viceconti@tecno.ior.it
Affatato
Saverio
S
Baleani
Massimiliano
M
Bordini
Barbara
B
Cristofolini
Luca
L
Taddei
Fulvia
F
D006622:Hip Prosthesis / Q000009:adverse effects; D006801:Humans; D007595:Joint Prosthesis / Q000009:adverse effects; D008422:Materials Testing; D008954:Models, Biological; D011475:Prosthesis Failure; D015203:Reproducibility of Results; D012306:Risk; D013997:Time Factors