No difference in clinical outcome but in RSA in total knee arthroplasty with the ATTUNE vs. the PFC Sigma: a randomized trial with 2-year follow-up.

Background and purpose: Despite usage of the ATTUNE total knee arthroplasty (TKA) for about 10 years, few randomized trials exist. We evaluated whether the ATTUNE CR design showed improved clinical results compared with the PFC Sigma CR after 2 years and if there was a difference in tibial component migration.

Patients and methods: 96 patients with knee osteoarthritis were randomly treated with cemented ATTUNE or PFC Sigma TKA. 42 patients with the ATTUNE and 48 with the PFC Sigma attended the 2-year follow-up. Patient-reported outcome measurements (PROMs), migration measured with RSA, implant position, and the development of radiolucent zones were studied. Non-parametric tests and repeated measures analysis were used at the statistical evaluation.

Results: The Oxford Knee Score (OKS) at 2 years (primary outcome) and neither of the secondary PROM outcomes differed between the groups (mean difference OKS ATTUNE - PFC: -0.08, 95% confidence interval [CI] -2.9 to 2.7). RSA showed posterior tilt of the tibial component in the ATTUNE group with proximal lift-off anteriorly and subsidence of the tibial tray posteriorly. In contrast, the PFC Sigma tibial component tilted forward (mean difference ATTUNE - PFC: -0.7°, CI -1.1° to -0.4°) with maximum subsidence in the front and maximum lift-off of the posterior edge. The postoperative implant positions and the extension of radiolucent lines around the tibial component at 2 years did not differ.

Conclusion: We found no significant differences in clinical outcome between the 2 groups but minor differences in migration pattern of the tibial component. The clinical long-term significance of this finding if any is not known.