Background: We previously reported the short-term radiographic and functional results of a randomized controlled trial (RCT) comparing computer-assisted and conventionally performed total knee replacement. We currently report the 2-year clinical results from this trial.

Methods: One hundred and ninety patients were randomly allocated to undergo either computer-assisted or conventional total knee replacement. One hundred and seventy-two patients were available for clinical evaluation at 2 years, and 167 (97%) of those answered all patient-reported outcome measures (PROMs), including the Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society Score (KSS), visual analog scale (VAS), and EuroQol-5 Dimensions (EQ-5D). Patients and clinical evaluators were blinded to the method of surgery. Surgical outcome was assessed using the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) criteria to calculate responder rates, divided into high responders, moderate responders, and nonresponders.

Results: The computer-assisted group had significantly more improvement than the conventional group in the mean scores for 2 subscales of the KOOS (7.4 for symptoms [p = 0.02] and 16.2 for sport and recreation [p < 0.01]) and in 1 subscale of the WOMAC (8.8 for stiffness [p = 0.03]).The computer-assisted group also had significantly more high responders (82.8%) than the conventional group (68.8%; p = 0.03) at 2 years, with the number needed to treat determined to be 8.

Conclusions: In this study, the use of computer navigation provided better pain relief and restored better function than the use of the conventional surgical technique at 2 years after total knee replacement.

Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.