3000 patients undergoing total knee arthroplasty (TKA) (2948 of whom completed the study) were randomized to the use of either antibiotic-loaded or non-antibiotic-loaded cement in the fixation of their prosthesis. The primary goal of this study was to compare infection rates between the two groups and the secondary goal was to determine if risk factors existed for deep infection. Results indicated that there was no difference between the two groups in terms of deep or superficial infection rates. In addition, male sex and an operative time of longer than 125 minutes were determined to be risk factors for deep infection.