Radiostereometric analysis using clinical radiographic views: Development of a universal calibration object.
Radiostereometric analysis (RSA) is a highly accurate technique used to provide three-dimensional (3D) measurements of orthopaedic implant migration for clinical research applications, yet its implementation in routine clinical examinations has been limited. Previous studies have introduced a modified RSA procedure that separates the calibration examinations from the patient examinations, allowing routine clinical radiographs to be analyzed using RSA. However, in order to calibrate the wide range of clinical views, a new calibration object is required. In this study, a universal, isotropic calibration object was designed to calibrate any pair of radiographic views used in the clinic for RSA. A numerical simulation technique was used to design the calibration object, followed by a phantom validation test of a prototype to verify the performance of the novel object, and to compare the measurement reliability to the conventional calibration cage. The 3D bias for the modified calibration method using the new calibration object was 0.032 ± 0.006 mm, the 3D repeatability standard deviation was 0.015 mm, and the 3D repeatability limit was 0.042 mm. Although statistical differences were present between the universal calibration object and the conventional cage, the differences were considered to be not clinically meaningful. The 3D bias and repeatability values obtained using the universal calibration object were well under the threshold acceptable for RSA, therefore it was successfully validated. The universal calibration object will help further the adoption of RSA into a more routine practice, providing the opportunity to generate quantitative databases on joint replacement performance.