We conducted this prospective randomised and externally evaluated study to investigate whether the use of a navigation system during total knee arthroplasty leads to significantly better results than the hand-guided technique. A total of 240 patients was included in the study. All patients received a condylar knee prosthesis. Two surgeons performed all the operations using the Stryker knee navigation system. Exclusion criteria included the necessity for the primary use of constrained implants. The results revealed a highly significant difference between the two groups in favour of navigation with regard to the mechanical axis, the frontal and sagittal femoral axis and the frontal tibial axis (p < 0.0001). The use of a navigation system was therefore shown to improve the alignment of the implant.