A 2-year RSA study of the Vanguard CR total knee system: A randomized controlled trial comparing patient-specific positioning guides with conventional technique.

Background and purpose - There is some concern regarding the revision rate of the Vanguard CR TKA in 1 registry, and the literature is ambiguous about the efficacy of patient-specific positioning guides (PSPGs). The objective of this study was to investigate the stability of the cemented Vanguard CR Total Knee using 2 different surgical techniques. Our hypothesis was that there is no difference in migration when implanting the Vanguard CR with either PSPGs or conventional technique. We hereby present a randomized controlled trial of 2-year follow-up with radiostereometric analysis (RSA). Patients and methods - 40 TKAs were performed between 2011 and 2013 with either PSPGs or the conventional technique and 22 of these were investigated with RSA. Results - The PSPG (8 knees) and the conventional (14 knees) groups had a mean maximum total point motion (MTPM) (95% CI) of 0.83 (0.48-1.18) vs. 0.70 (0.43-0.97) mm, 1.03 (0.60-1.43) vs. 0.86 (0.53-1.19), and 1.46 (1.07-1.85) vs. 0.80 (0.52-1.43) at 3, 12, and 24 months respectively (p = 0.1). 5 implants had either an MTPM >1.6 mm at 12 months and/or a migration of more than 0.2 mm between 1- and 2-year follow-ups. 2 of these also had a peripheral subsidence of more than 0.6 mm at 2 years. Interpretation - 5 implants (3 in the PSPG group) were found to be at risk of later aseptic loosening. The PSPG group continuously migrated between 12 and 24 months. The conventional group had an initial high migration between postoperative and 3 months, but seemed more stable after 1 year. Although the difference was not statistically significant, we think the migration in the PSPG group is of some concern.