New implants for total knee arthroplasty (TKA) are frequently introduced with the promise of improved performance. Infrequently there is accompanying data to document relative performance. The goal of this study was to evaluate the outcomes of an implant widely used for decades (Existing TKA), compared to a new implant (New TKA) from the same manufacturer. From October 2011-March 2015, 19 sites prospectively enrolled and implanted 752 Subjects with Existing TKA. Between November 2012 and May 2015, 23 sites (18 sites had enrolled Existing TKAs), implanted 1131 Subjects with the New TKA. Demographics were similar between groups. Subjects were seen preoperatively, <1-year, 1-year, and 2-years to collect patient reported outcome measures (PROMs), radiographs and any complications. PROMs consisted of Knee Injury and Osteoarthritis Outcome Score (KOOS) (permits WOMAC scoring), Oxford Knee Score (OKS), Patient's Knee Implant Performance (PKIP) and EQ5D-3L and a p-value of 0.01 was established for statistical significance for PROMs comparisons. Kaplan-Meier (KM) implant survivorship (revision of any component for any reason) estimates were calculated.Introduction
Methods
This study was conducted to assess the results in two subgroups:a) the effect of the PFC Sigma as compared to the PFC total knee replacement in lowering patella lateral release rates and b) the results of severe fixed flexion deformity correction with emphasis on some technical operative details. Data is collected prospectively on all patients undergoing total knee replacements for an ongoing research programmer. As part of this project, we assessed the patella lateral release rate in 954 knees performed between April 1994 and January 2000. Lateral release was reached in 55 out of 592 PFC knees compared with 25 out of 362 Sigma knees. The overall lateral release rate was 8.3%. Using the Chi squared test, there is a statistically significant lower lateral release rate using the Sigma system and the study also demonstrated a low overall lateral release rate in our entire series. The biomechanics of the PFC Sigma system and some operative technical points will be discussed in the talk. As regards the fixed flexion deformity group data was once again collected prospectively on the Knee Society Scoring form. The results are as follows: Preoperative flexion deformity >
20 degrees = 53 knees, (Range 20 to 60 degrees), Preoperative Mean Knee Score = 17.2, Postoperative flexion deformity <
5 degrees=91% Postoperative Mean Knee Score = 90.04. These numbers and results are comparable to other large series and some technical operative details will be discussed in the talk.
