Computed tomography-based radiostereometric analysis achieves sufficient precision for femoral implants in total knee arthroplasty: a randomized controlled trial
Abstract
Background: Conventional radiostereometric analysis (RSA) has been used for several decades to assess implant migration in total knee arthroplasty (TKA). More recently, computed tomography-based radiostereometric analysis (CT-RSA) has been introduced as an alternative. Experimental studies have demonstrated acceptable precision for CT-RSA; however, this has not yet been validated in a clinical setting. With the emergence of new alignment philosophies in TKA, migration analysis of femoral components has become increasingly important. A key criticism of CT-RSA has been the higher radiation doses compared with conventional RSA, particularly in longitudinal studies involving repeated CT scans. In this study, we evaluated the precision of CT-RSA for assessing femoral component migration in two TKA designs at two different radiation dose levels. We hypothesized that there would be no clinically relevant difference in precision between the two radiation dose levels.
Methods: We performed a randomized controlled trial of 50 patients using Tritanium and GMK Sphere 3D Metal implants and analysed the precision of the method through double examinations expressed as means with 95% confidence intervals at standard and low-dose levels. The main outcome variable was the difference in mean maximum total point motion. We set the clinical meaningful difference to be more than 0.1 mm based on existing literature. Secondary outcome variables were the means and standard deviations of the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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