Abstract
Background
Innovative developments for total knee arthroplasty enhanced anatomical design and fixation in order to decrease particle-induced aseptic implant loosening. As hypersensitivity reactions to metallic implant materials have been recognized to possibly cause premature implant failure, ceramic materials might constitute a proper alternative solution. The aim of this prospective short-term study was the initial comparison of a completely metal-free ceramic with a geometrically identical metallic arthroplasty over a one-year follow-up period.
Methods
Eighty patients requiring primary total knee arthroplasty were enrolled within this open-label prospective comparative study. Patients were randomly divided among two groups to either undergo implantation of a completely metal-free system using a composite matrix material containing aluminum oxide (Al2O3) and zirconium oxide (ZrO2) (n=40), or an anatomically identical metallic knee system made of a cobalt-chromium alloy (Co28Cr6Mo) (n=40) produced by the same manufacturer. Clinical assessment was performed preoperatively, and during follow-up at three and twelve months using the Knee Society Score, Oxford Knee Score and EQ-5D-VAS. For radiological evaluation, standard preoperative and postoperative standardized radiographs were taken at mentioned follow-up visits.
Results
Demographical data were not significantly different among our two study groups, and no patient has been lost to follow-up. The postoperative clinical scores improved significantly at three and twelve month follow-ups, but did not differ statistically among groups. The radiologically evaluated mean postoperative mechanical and anatomical axes showed proper alignment within both groups at all times. Notably, no revision surgery had to be performed, and no complications were recorded whatsoever.
Conclusion
To our knowledge, this is the first study comparing a total ceramic metal-free knee system with a geometrically identical metallic TKR. Within the short-term follow-up of minimally one year, no significant differences could be demonstrated clinically or radiologically, therefore making this ceramic knee system a suitable option for patients with a known hypersensitivity to metal. Mid-term and long-term studies will be required to demonstrate the overall efficiency of this TKR to potentially expand its medical indication.
