Introduction: Optimal component position in all planes and well balanced soft tissues lead to a good clinical outcome and long-term survival after total knee arthroplasty. We investigated the implantation accuracy of navigated total knee arthroplasty at 3 months followup and the influence on the clinical outcome at 2 years followup.

Patients and Methods: Forty-four patients (44 procedures) were enrolled in our prospective study. One half of the surgeries were performed using a computed tomography based navigation system, and one half of the surgeries were performed without computed tomography navigation. Outcomes were based on the Insall knee score parameters, anterior knee pain, patient satisfaction, feeling of instability, and step test. The radiographic parameters were the mechanical axis, tibial slope, lateral distal femoral angle, and medial proximal tibial angle.

Results: The radiographic measurements showed no differences between both groups (patients within ± 3° inaccuracy range in computed tomography based/computed tomography free groups; mechanical axis 86%/81%, tibial slope 95%/91%, lateral distal femoral angle 95%/91%, medial proximal tibial angle 91%/95%). The cumulative error of alignment showed no difference between the study groups. Seventeen of 21 (81%) patients fulfilled four criteria in the CT based group, and 15 of 21 (71.4%) patients fulfilled four criteria in the comparison group. Nineteen of 21 (90.5%) patients in both groups achieved three criteria in an optimal manner. An increased (p < 0.001) Insall knee score was found for changes over time in both study groups; however, there were no differences between the CT based or CT free patient groups. The postoperative ROM in both groups showed no difference at the 3-month and 2-year followup examinations. Both groups had an increase (p ≤ 0.002) in ROM between the 3-month and 2-year followup examinations. The examination of ligament balancing in full extension showed a higher rate of a stable soft tissue situation in the CT free navigation group but the difference was not significant. In 30° of flexion we detected a better (p = 0.004) ligament situation medially and laterally in the CT free group. The anterior drawer test showed a better (p = 0.035) stability in the CT free navigation group.

Discussion: The computed tomography free system provided equal radiographic results, but we found improved ligament balancing in the computed tomography free group. The computed tomography based module has an optimal preoperative planning procedure, but is more expensive and time consuming.