Abstract
Background
Migration analysis after total joint arthroplasty are performed using EBRA analysis (Krismer et al., 1997) or - more accurate but also much more cost-intensive and time-consuming – via radiostereometric analysis (RSA). For the latter, additional radiographs from two inclined perspectives are needed in regular intervals in order to define the position of the implant relative to tantalum bone markers which have been implanted during surgery of the artificial joint (Fig. 1). Modern analysis software promises a migration precision along the stem axis of a hip implant of less than 100 μm (Witvoet-Brahm et al., 2007). However, as the analysis is performed semi-automatically, the results are still dependent on the subjective evaluation of the X-rays by the observer. Thus, the present phantom study aims at evaluating the inter- and intra-observer reliability, the repeatability as well as the precision and gives insight into the potential and limits of the RSA method.
Materials and Methods
Considering published models, an RSA phantom model has been developed which allows a continuous and exact positioning of the prostheses in all six degrees of freedom (Fig. 2). The position sensitivities of the translative and rotative positioning components are 1 μm and 5 to 24, respectively. The roentgen setup and Model-Based RSA software (3.3, Medis specials bv, Leiden, Netherlands) was evaluated using the SL-PLUS® standard hip stem (size 7, Smith & Nephew, Baar, Switzerland). The inter-observer (10 repetitions) and intra-observer (3 observers) reliability have been considered. Additionally, the influences of the model repositioning and inclination as well as the precision after migration and rotation along the stem axis are investigated.
Results and Discussion
Precision along the stem axis was determined to 161 μm (± 230 μm), in the lateral plane 100 μm (± 85 μm) and maximal rotations to 0.524° (± 1.268°). High reproducibility (intra-observer reliability) is reported with relevant influences of the inclination of the implant on the radiograph, in particular for the first clinical scene which serves as a reference. Deviations after translations along the stem axis are 0.37 ± 1.92% and −3.28 ± 6.62% after rotations.
In conclusion, the precision given by the software producer of less than 100 μm could not be verified. Beside the limitations from the software, potential sources of errors are the subjective analysis by the observer, a small number of bone markers and the positioning of the implant (patient) during X-ray examination. Though, Model-Based RSA largely outmatches the EBRA approach in terms of measuring implant migration. However, standardization of the X-rays and RSA analysis is recommended.
