Abstract
Introduction/Aim
The NAVIO robotic-assisted TKA (RA-TKA) application received FDA clearance in May 2017. This semi-active robotic technique aims to improve the accuracy and precision of total knee arthroplasty. The addition of robotic-assisted technology, however, also introduces another potential source of surgery-related complications. This study evaluates the safety profile of NAVIO RA-TKA.
Materials and Methods
Beginning in May 2017, the first 250 patients undergoing NAVIO RA-TKA were included in this study. All intra-operative complications were recorded, including: bleeding; neuro-vascular injury; peri-articular soft tissue injury; extensor mechanism complications; and intra-operative fracture. During the first 90 days following surgery, patients were monitored for any post-operative complications, including: superficial and deep surgical site infection; pin-tract infection; pin site fractures; peri-prosthetic fractures; axial or sagittal joint instability; axial mal-alignment; patello-femoral instability; DVT/PE; re-operation or re-admission due to surgical-related complications.
Surgical technique and multi-modality pain management protocol was consistent for all patients in the study. A combined anesthetic technique was employed for all cases, including: low-dose spinal, adductor canal block and general anesthetic. Patients were mobilized per our institution's rapid recovery protocol.
Results
No patients were lost to follow-up.
During the study period, no intra-operative complications were recorded. Specifically, no complications related to the introduction of the high-speed burr associated with the NAVIO RA-TKA were noted.
Within the 90-day follow-up period, there was one case of deep infection. One patient sustained a fall resulting in a peri-prosthetic femoral fracture, that occurred remote from the femoral pin tracts. No cases of axial or sagittal joint instability, axial mal-alignment, patello-femoral instability, pin site infections or fractures; or DVT/PE were identified. Four patients underwent manipulation under anesthesia. No other patients required a re-operation or re-admission due to surgical-related complications.
Discussion/Conclusions
The initial experience with the NAVIO robotic assisted total knee arthroplasty has demonstrated excellent safety profile. Relative to known risks associated with total knee arthroplasty, no increased risk of peri-operative complications, re-operation or re-admission for surgical related complications was identified with the introduction of the NAVIO RA-TKA.
