title: Pre-clinical validation of joint prostheses: a systematic approach.
abstract: 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.
authors.affiliation: Laboratorio di Tecnologia Medica, Istituti Ortopedici Rizzoli, Italy. viceconti@tecno.ior.it
authors.forename: Marco
authors.initials: M
authors.lastname: Viceconti
authors.forename: Saverio
authors.initials: S
authors.lastname: Affatato
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Baleani
authors.forename: Barbara
authors.initials: B
authors.lastname: Bordini
authors.forename: Luca
authors.initials: L
authors.lastname: Cristofolini
authors.forename: Fulvia
authors.initials: F
authors.lastname: Taddei
mesh_terms: 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