Conventional versus Smart Wireless Navigation in Total Knee Replacement: Similar Outcomes in a Randomized Prospective Study.

Purpose  The development of new computer-assisted navigation technologies in total knee arthroplasty (TKA) has attracted great interest; however, the debate remains open as to the real reliability of these systems. We compared conventional TKA with last generation computer-navigated TKA to find out if navigation can reach better radiographic and clinical outcomes. Methods  Twenty patients with tricompartmental knee osteoarthritis were prospectively selected for conventional TKA ( n  = 10) or last generation computer-navigated TKA ( n  = 10). Data regarding age, gender, operated side, and previous surgery were collected. All 20 patients received the same cemented posterior-stabilized TKA. The same surgical instrumentation, including alignment and cutting guides, was used for both the techniques. A single radiologist assessed mechanical alignment and tibial slope before and after surgery. A single orthopaedic surgeon performed clinical evaluation at 1 year after the surgery. Wilcoxon's test was used to compare the outcomes of the two groups. Statistical significance was set at p  < 0.05. Results  No significant differences in mechanical axis or tibial slope was found between the two groups. The clinical outcome was equally good with both techniques. At a mean follow-up of 15.5 months (range, 13-25 months), all patients from both groups were generally satisfied with a full return to daily activities and without a significance difference between them. Conclusion  Our data showed that clinical and radiological outcomes of TKA were not improved by the use of computer-assisted instruments, and that the elevated costs of the system are not warranted. Level of Evidence  This is a Level II, randomized clinical trial.