Abstract
The traditional criterion for the diagnosis of implant loosening in total hip arthroplasty (THA) was once defined as a radiolucent line of >2 mm in width, based on plain radiography. Recent progress in imaging technology has allowed for the identification of complete radiolucent lines of ≤2 mm around the whole prosthesis as the basis for diagnosing component loosening in the absence of component migration. This study aimed to compare the sensitivity and specificity of digital tomosynthesis with metal artifact reduction with those of radiography and conventional computed tomography (CT) for detecting radiolucent lines of ≤2 mm surrounding cementless femoral stems of different widths. The medullary canals of 4 cadaveric femurs were broached to 13 mm in diameter. Cylindrical cementless femoral stems with diameters of 9, 10, 11, 12, and 13 mm were sequentially inserted into each femur, creating 5 groups of radiolucent lines 2.0, 1.5-1.6, 1.1-1.2, 0.5-0.6, and 0 mm in diameter, respectively. Imaging by tomosynthesis, radiography, and CT was conducted for each radiolucent line model. The width information of the radiolucent line models was used as a reference standard for calculating sensitivity and specificity: observations in the group of 0 mm were used for calculating specificity, and those in the other four groups were used for sensitivity. The differences in sensitivity and specificity between the imaging methods were compared with chi-square test, and the 95% confidence intervals of improvements in the sensitivity and specificity of tomosynthesis compared with radiography and CT were calculated using mixed effects models. The overall sensitivity of tomosynthesis (63.3%) for detecting radiolucent lines ≤2 mm wide was significantly higher (P<0.017) than that of radiography (20.5%) and CT (50.2%), an improvement of 58.2%±3.1% (95% CI, P<0.001) and 21.7%±7.1% (95% CI, P<0.001) compared to radiography and CT, respectively. The sensitivity values for detecting radiolucent lines in all four groups by tomosynthesis and CT were significantly higher than those of radiography (P<0.017). Tomosynthesis also had significantly higher sensitivity than CT (P<0.017) in detecting radiolucent line ≤1.2 mm wide. The specificity of TMAR, radiography, and CT for detecting radiolucent lines was 87.5%, 92.5%, and 82.5%, respectively, with no significant difference (P>0.017). Digital tomosynthesis with metal artifact reduction had significantly higher sensitivity than radiography for detecting radiolucent lines ≤2 mm wide surrounding cementless femoral stems. It also displayed higher sensitivity than CT for detecting radiolucent lines ≤1.2 mm in width. With a higher rate of detection for radiolucent lines narrower than 2 mm, tomosynthesis has the potential to improve the accuracy of early diagnosis of cementless THA stem loosening in clinical practice.
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