Early- to Mid-Term Review of a Prospective, Multi-Center, International, Outcomes Study of an Anatomically Designed Implant with Posterior-Stabilized Bearing in Total Knee Arthroplasty

Abstract

Background and Objectives: National joint registries report higher total knee arthroplasty (TKA) revision rates in posterior-stabilized (PS) systems compared to non-posterior-stabilized designs. The purpose of this study was to investigate the implant survivorship and clinical outcomes of an anatomic implant with a PS bearing. Materials and Methods: An early- to mid-term follow-up of a prospective, multi-center, non-controlled outcomes study of patients who received primary TKA between November 2014 and June 2017 was performed. A total of 800 cases using PS bearings that were implanted in 664 patients were monitored post-operatively for their implant survivorship and adverse events for up to five years. The Knee Society Knee and Function scores, patient satisfaction, the five-dimensional European Quality of Life questionnaire, and range of motion (ROM) were evaluated pre-operatively and post-operatively at six weeks, six months, one year, two years, three years, and five years. Results: The mean follow-up period was 3.7 ± 1.3 years, and the three-year implant survival rate was 99.3% (95% CI: 98.4%, 99.7%) with five revisions during the five-year follow-up. Patient satisfaction was 96.1% at six weeks and increased to 99.3% at one year. All patient-reported outcome measures significantly (p < 0.0001) increased up to the one-year follow-up and then remained stable up to the five-year follow-up. Conclusions: This study supports the excellent survivorship and patient-reported outcomes of the Persona® Knee system using cemented, fixed bearing, posterior-stabilized components with minimal complications at early- to mid-term follow-up in an international Asian population. Ongoing observations are being performed to investigate the mid- to long-term survivorship and clinical outcomes associated with this knee system.