Abstract
Purpose
A concern that arises with any new prosthesis is whether it will achieve satisfactory long-term implant stability. The gold standard of assessing the quality of fixation in a new or relatively new implant is to undertake a randomized controlled trial using radiostereometric analysis. It was hypothesized that both mobile-bearing total knee arthroplasty and fixed-bearing total knee arthroplasty have comparable migration patterns at 2-year follow-up. This study investigated two types of cemented total knee arthroplasty, the mobile- or fixed-bearing variant from the same family with use of radiostereometric analysis.
Methods
This prospective, patient-blinded, randomized, controlled trial was designed to investigate early migration of the tibia component after two years of follow-up with use of radiostereometric analysis. A total of 50 patients were randomized to receive a mobile- or fixed-bearing TKA from the same family. Patients were evaluated during 2-year follow-up, including radiostereometric analysis, physical and clinical examination and patient reported outcome measures (PROMs).
Results
At two-year follow-up, the mean (±SD) maximum total point motion (MTPM) in the fixed-bearing group was 0.82 (±1.16) versus 0.92 mm (±0.64) in the mobile-bearing group (p = n.s) with the largest migration seen during the first 6 weeks (0.45 ± 0.32 vs. 0.54 ± 0.30). The clinical outcome and PROMs significantly improved within each group, not between both groups.
Conclusions
Measuring early micromotion is useful for predicting clinical loosening that can lead to revision. The results of this study demonstrate that early migration of the mobile-bearing is similar to that of the fixed-bearing component at two years and was mainly seen in the first weeks after implantation.
Level of evidence
Randomized, single-blind, controlled trial, Level I.
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Acknowledgments
The authors would like to express their gratitude to Dr Rob Sollie (MD) and Dr Kevyn Mejia-Hernandez (MD) from Flinders Medical Centre Adelaide, Australia, who served as external readers, for their comments that greatly improved the manuscript.
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One author (NK) is a paid consultant on the PSG surgical technique for Biomet, Europe. One author (PP) currently also a paid employee of Zimmer Biomet. This was not the case when the study was set up. The other authors certify that they have no commercial associations (e.g. consultancies, stock ownership, equity interest and patent/licensing arrangements) that might pose a conflict of interest in connection with the submitted manuscript.
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Schotanus, M.G.M., Pilot, P., Kaptein, B.L. et al. No difference in terms of radiostereometric analysis between fixed- and mobile-bearing total knee arthroplasty: a randomized, single-blind, controlled trial. Knee Surg Sports Traumatol Arthrosc 25, 2978–2985 (2017). https://doi.org/10.1007/s00167-016-4138-6
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DOI: https://doi.org/10.1007/s00167-016-4138-6