Is Model-based Radiostereometric Analysis Suitable for Clinical Trials of a Cementless Tapered Wedge Femoral Stem?

Abstract

Background: In clinical trials of THA, model-based radiostereometric analysis (RSA) techniques may be less precise than conventional marker-based RSA for measurement of femoral stem rotation. We verified the accuracy and clinical precision of RSA based on computer-aided design models of a cementless tapered wedge femoral stem. Questions: We asked: (1) Is the accuracy of model-based RSA comparable to that of marker-based RSA? (2) What is the clinical precision of model-based RSA? Methods: Model-based RSA was performed using combined three-dimensional computer-aided design models of the stem and head provided by the implant manufacturer. The accuracy of model-based RSA was compared with that of marker-based RSA in a phantom model using micromanipulators for controlled translation in three axes (x, y, z) and rotation around the y axis. The clinical precision of model-based RSA was evaluated by double examinations of patients who had arthroplasties (n = 24) in an ongoing trial. The clinical precision was defined as being at an acceptable level if the number of patients needed for a randomized trial would not differ from a trial done with conventional marker-based RSA (15–25 patients per group). Results: The accuracy of model-based RSA was 0.03 mm for subsidence (translation along the y axis) (95% CI for the difference between RSA measurements and actual displacement measured with micrometers, −0.03–0.00) and 0.39° for rotation around the y axis (95% CI, −0.41 to −0.06). The accuracy of marker-based RSA was 0.06 mm for subsidence (95% CI, −0.04–0.01; p = 0.728 compared with model-based RSA) and 0.18° for the y axis rotation (95% CI, −0.23 to −0.07; p = 0.358). The clinical precision of model-based RSA was 0.14 mm for subsidence (95% CI for the difference between double examinations, −0.02–0.04) and 0.79° for the y axis rotation (95% CI, −0.16–0.18). Conclusions: The accuracy of model-based RSA for measurement of the y axis rotation was not quite as high as that of marker-based RSA, but its clinical precision is at an acceptable level. Clinical relevance: Model-based RSA may be suitable for clinical trials of cementless tapered wedge femoral stem designs.