Abstract
Introduction
Total knee arthroplasty (TKA) using conventional instrumentation has been shown to be a safe and effective way of treating end stage osteoarthritis by restoring function and alleviating pain. As robotic technology is developed to assist surgeons with intra-operative decision making such as joint balancing and component positioning, the safety of these advancements must be established. Furthermore, functional recovery and clinical outcomes should achieve comparable results to the gold standard of conventional instrumentation TKA.
Methods
Eighty-seven subjects (89 knees) underwent robotic arm assisted TKA by one of three investigators as part of an FDA and IRB approved Investigational Device Exemption (IDE). To achieve the primary endpoint of intra-operative patient safety using a robotic arm assisted cutting tool, the investigators completed questionnaires to assess a series of complications related to soft tissue damage associated with conventional TKA. Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee Society Knee Scores (KSS) were collected pre-operatively and at three month follow-up.
Results
The average subject age was 65.8 ± 8.5 and the average BMI was 31.4 ± 5.7. 55% of the subjects were female. No subject experienced any of the rare intra-operative complications that comprise the primary safety endpoint. The average WOMAC score improvement from pre-operative to three months was 33.1 ± 20.04 (p<0.0001). The average KSS Knee score improvement was 46.1 ± 19.7 (p<0.0001). Subjects recovered their pre-operative range of motion by three months post-operative.
Conclusion
Results from this prospective robotic arm assisted trial indicated greater intra-operative safety in blood loss and ligamentous damage when compared to conventional TKA. Subjects had excellent return to function and pain relief by three months as indicated by the KSS and WOMAC scores. Robotic technologies should be considered a safe and effective method in total joint restoration.
