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Rigshospitalet - en del af Københavns Universitetshospital
Udgivet

Evaluation of different coatings of the tibial tray in uncemented total knee arthroplasty. A randomized controlled trial with 5 years follow-up with RSA and DEXA

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Vis graf over relationer

Background: Regenerex® is a porous titanium construct with a 3D interconnecting pore structure and biomechanical characteristics close to that of normal trabecular bone. This study aimed to compare the Regenerex (VR) to the non-interconnecting pore structure Porous Plasma Spray (VP) on tibial implants for total knee arthroplasty (TKA) at 5 years. Methods: We enrolled and randomized 61 patients (mean age = 63(49–71) years, Female/Male = 35/26) who were planned for an uncemented Vanguard TKA (Biomet, Warsaw, Indiana, USA) to receive either a VR or a VP coated tibial component (31/29). We performed radiostereometric analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) postoperatively, and at three, six, 12, 24 and 60 months with measurements of migration. In total 55 patients attended the 5-year follow-up. Results: One patient died and four were reoperated during the 60-months period; none due to aseptic loosening. All reoperations were in the VR-group. The mean (range) 60-months MTPM was 1.4 mm (0.5–3.7) for the VP-group and 1.8 mm (0.4–4.9) for the VR-group (p = 0.8). The 24 to 60-months mean (range) MTPM was −0.3 mm (−5 to 1.24) in the VP-group and 0.2 mm (−0.4 to 3.5) in the VR-group (p = 0.8). Conclusion: We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration. We will continue to follow the groups for years to come.

OriginalsprogEngelsk
TidsskriftKnee
Vol/bind29
Sider (fra-til)208-215
Antal sider8
ISSN0968-0160
DOI
StatusUdgivet - 1 mar. 2021

Bibliografisk note

Funding Information:
Financial support for the 5-year follow-up that is presented in this article was received from Lima corporate S.p.A. (Udine, Italy) and the original 2-year follow-up was funded by a research grant from Biomet (Dordrecht, The Netherlands). The companies did not take part in the planning, data collection, analysis, interpretation of the results, or in writing the manuscript. Besides the above funding, the authors GF and MMP reports potential conflicts of interest with regards to research grants and representation outside this study (for details see the Declaration of Interest form).

Publisher Copyright:
© 2021 The Authors

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

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