Free Content Guidelines for standardization of radiostereometry (RSA) of implants

Authors: Valstar, Edward1; Gill, Richie2; Ryd, Leif1; Flivik, Gunnar3; Börlin, Niclas4; Kärrholm, Johan1

Source: Acta Orthopaedica, Volume 76, Number 4, August 2005 , pp. 563-572(10)

Publisher: Informa Healthcare

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Abstract:

There is a need for standardization of radiostereometric (RSA) investigations to facilitate comparison of outcome reported from different research groups. In this document, 6 research centers have agreed upon standards for terminology, description and use of RSA arrangement including radiographic set-up and techniques. Consensus regarding minimum requirements for marker stability and scatter, choice of coordinate systems, and preferred way of describing prosthetic micromotion is of special interest. Some notes on data interpretation are also presented. Validation of RSA should be standardized by preparation of protocols for assessment of accuracy and precision. Practical issues related to loading of the joint by weight bearing or other conditions, follow-up intervals, length of follow-up, radiation dose, and the exclusion of patients due to technical errors are considered. Finally, we present a checklist of standardized output that should be included in any clinical RSA paper. This document will form the basis of a detailed standardization protocol under supervision of ISO and the European Standards Working Group on Joint Replacement Implants (CEN/TC 285/WG4). This protocol will facilitate inclusion of RSA in a standard protocol for implant testing before it is released for general use. Such a protocol—also including other recognized clinical outcome parameters—will reduce the risk of implanting potentially inferior prostheses on a large scale.

Document Type: Research article

DOI: http://dx.doi.org/10.1080/17453670510041574

Affiliations: 1: Department of Orthopaedics, Sahlgrenska University Hospital, Göteborg, Sweden 2: Nuffield Department of Orthopaedic Surgery, University of Oxford, Nuffield Orthopaedic Centre, Oxford, UK 3: Department of Orthopedics, Lund University Hospital, Lund 4: Department of Computing Science, Umeå University, Umeå

Publication date: 2005-08-01

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