Dose reduction does not impact precision of CT-RSA in tibial components in total knee arthroplasty: a randomized controlled trial

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PURPOSE: Radiostereometric analysis (RSA) has been the gold standard for implant migration analysis for decades. Our group previously demonstrated in a porcine cadaver model that CT-RSA precision was non-inferior by dose reduction. The aim of this study was to investigate whether this finding applied in a clinical setting. METHODS: This study is part of the ClessTKA trial comparing a novel 3D printed uncemented medially stabilized total knee arthroplasty (TKA) with Tritanium TKA. Fifty patients were recruited (GMK Sphere n = 26, Tritanium n = 24). All surgeries were performed with mechanical alignment between January and June 2023. CT acquisitions were performed postoperatively within 2 days (standard dose 0.05 mSv, n = 49) and at 1 year (low dose 0.01 mSv, n = 47) using a GE Revolution scanner. CT-RSA analyses of tibial components were performed with Sectra CTMA software by a certified assessor. The primary endpoint was difference in precision (mean) of maximum total point motion (MTPM) between dose levels, with an equivalence interval of 0-0.1 mm. RESULTS: Mean difference (95% CI) in MTPM under zero motion circumstances between standard and low dose was 0.007 mm (- 0.018 to 0.032). No clinically meaningful differences were found for migration or rotations. Centre-of-mass analysis showed one significant but clinically irrelevant posterior translation (0.013 mm). CONCLUSION: The findings confirm that reducing the effective radiation dose from 0.05 mSv to 0.01 mSv does not compromise the precision of CT-RSA for tibial components in TKA. The results further support the use of low-dose CT-RSA protocols in clinical studies, enabling substantial reduction in patient radiation exposure without loss of precision. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT05651009. Initial release of the study was November 23, 2022. At that time, the software CTMA (Sectra) did not provide the very important Maximum Total Point Motion (MTPM), this was introduced in a later update of the CTMA. Hence there was change in the original protocol retrospectively.

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