Radiostereometry and new prostheses

Radiostereometry and new prostheses Open Access-This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the source is credited. The meeting was attended by 110 participants from 12 countries, including the USA, Canada, and not least Sweden—the country in which the clinical use of RSA was initiated by Göran Selvik. The large worldwide attendance of the meeting clearly indicates that the use of RSA is spreading across the world. It has not only attracted the attention of surgeons, researchers, and the orthopedics industry but also that of the regulatory bodies in Europe, the United States, and Australia. There is growing awareness that new joint replacement prostheses, cements, and surgical techniques should be thoroughly evaluated before general release onto the market. Thus, the rather erratic introduction of new prostheses or new procedures should be replaced by a phased introduction, an approach that has been mandatory in the pharmaceutical industry for decades (Nelissen et al. 2011). One would expect that disasters such as with Boneloc cement and the Capital hip prosthesis could not happen today. However, in general the introduction of new prostheses is still done in almost the same way as it was 20 years ago. More than 25 years ago, Malchau (1995) proposed a controlled, stepwise introduction of new prostheses. This message has been given many times, even in editorials in Acta (Bauer 1992, Kärrholm 2003). However, recent problems with the Proxilock hip, the ASR hip, the Accord knee, and the St. Leger knee illustrate the urgent need for improved early evaluation of new pros-theses—a process best performed in cooperation between the orthopedic community, industry, and regulators. The potential of RSA as a method of early (pre-introductory) assessment of implant performance is substantial. This potential is currently being recognized by various regulatory bodies at different levels. The NICE guidelines of 2003 (UK) require adequate long-term clinical data for hip prostheses and suggest RSA as a promising technique that may be an alternative for long-term follow-up studies. However, additional proof of its predictive value regarding future loosening is not only advised but also demanded by regulatory bodies. In its new guidelines for hip prostheses, the Dutch Orthopaedic Society has stated that any new hip prosthesis that is being considered for (commercial) introduction to the Dutch market must go through a phased introduction (Swierstra et al. …