Patient-reported outcomes and complications of a new-generation total knee system: a randomized controlled trial.

研究概要

Three hundred fourteen patients with primary osteoarthritis undergoing total knee arthroplasty were randomized to receive either the Persona (n=157) or NexGen (n=157) cruciate-retaining total knee arthroplasty system. The primary outcome of interest was the Oxford Knee Score (OKS) at 2 years post-surgery. Secondary outcomes included the Oxford Knee Score Activity and Participation Questionnaire (OKS-APQ), Forgotten Joint Score (FJS), EQ-5D-3L index and VAS, and the number of complications. Outcomes were assessed at 3 months, 1 year, and 2 years. Overall, the results of the study revealed no statistically or clinically significant differences in the OKS or any secondary patient-reported outcomes between the groups. The findings suggest that the short-term performance and safety of the Persona system are comparable to the NexGen system.