Robotic-Assisted Total Knee Arthroplasty Utilizing NAVIO, CORI Imageless Systems and Manual TKA Accurately Restore Femoral Rotational Alignment and Yield Satisfactory Clinical Outcomes: A Randomized Controlled Trial

Background and objectives: The introduction of novel techniques in total knee arthroplasty (TKA) aiming to enhance outcomes and satisfaction of the procedure is constantly ongoing. In order to evidence a priority of one, we have conducted a randomized controlled trial with the aim of comparing patient-reported functional outcomes, radiographic outcomes and intraoperative measures between imageless (NAVIO and CORI), robotic-assisted (ra)- TKA (ra-TKA) and manual TKA (mTKA) for primary knee osteoarthritis (KOA). Materials and Methods: A total of 215 patients with the diagnosis of KOA of the knee were randomly assigned to one of the three groups: NAVIO (76 patients) or CORI (71 patients) robotic-assisted TKA, or manual technique (68 patients) TKA. The primary outcome (Knee Injury and Osteoarthritis Outcome Study [KOOS]), Visual Analogue Scale (VAS), Range of motion (ROM), femoral component rotational alignment and the secondary outcomes (surgery time, blood loss, complications, and revision at 12 months after surgery) were compared between three groups. KOOS and VAS were collected at particular follow up visits from each patient individually and ROM in flexion and extension was assessed during the physical examination. Femoral component rotational alignment was measured on the CT scan performed postoperatively utilizing the Berger's method. Statistical significance was set at p < 0.05. Results: Both the ra-TKA groups and mTKA group displayed significant improvements in the majority of the functional outcome scores at 12 months. Despite having more prominent surgery time (NAVIO: mean +44.5 min in comparison to mTKA and CORI: mean +38.5 min in comparison to mTKA), both NAVIO and CORI tend to achieve highly accurate femoral component rotational alignment with mean radiographic scores in NAVIO vs. CORI vs. mTKA of 1.48° vs. 1.33° vs. 3.15° and lower blood loss (NAVIO: 1.74; CORI: 1.51; mTKA: 2.32. Furthermore, the investigation revealed the significant difference in femoral component rotational alignment between mTKA-NAVIO and mTKA-CORI and significantly different KOOS scores in NAVIO vs. CORI vs. mTKA of 87.05 vs. 85.59 vs. 81.76. Furthermore, the KOOS analysis showed between group significant statistical differences, but did not reach minimal clinically significant difference. There were no differences in postoperative ROM and VAS. There were no differences in complications between groups. Conclusions: To achieve a successful TKA, the precise tool and individualised objective is of great importance. The results suggest satisfactory results after both ra-TKA methods and mTKA. Ra-TKA and mTKA stand for a safe and reliable treatment method for OA. Patients reported excellent alleviation in functional outcomes and the radiological results revealed that the better precision does not necessarily lead to a better outcome. Therefore, ra-TKA does not imply strong enough advantages in comparison to the manual method, especially in terms of cost-efficiency and surgical time.