The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas.

Abstract

The optimum method for the appropriate introduction of innovative technologies into orthopedics is a vital but vexing issue. Compromises in the introduction process are driven by (a) the magnitude of the problem addressed (incidence and severity), (b) the advantages and risks of the proposed solution, and (c) the "universal dilemma," meaning the inherent "gap" between all the nonhuman supporting data and the unknowns of both efficacy and long-term safety in large human usage over many years. Drawing on the data generated and the actual decision tree used in the introduction of a new highly cross-linked polyethylene as a case study, this article illustrates these "subsequent dilemmas."