ObjectivesLimited data exists on complications associated with robotic image-based system in knee arthroplasty. This study aims to document complications in robotic arm-assisted knee arthroplasties, and evaluate the system’s safety by comparing two femoral pin insertion methods: bicortical diaphyseal with additional stab wounds, and unicortical metaphyseal placement through the main incision. MethodsAll patients undergoing primary knee arthroplasty with the image-based robotic system (Mako, Stryker, Mako Surgical Corp., Fort Lauderdale, FL, USA) from 1st March 2021 to 31st January 2024 with a minimum follow-up of 2 months were included. Demographics, system and non-system-related complications, as well as outcomes were recorded. Complications were categorized as either major (requiring a second surgical intervention) or minor. ResultsA total of 970 consecutive cases (median age 69.3 years) were analyzed. The unicortical group comprised 651 cases, while the bicortical group 319. The incidence of non-system-related complications was 2.37%, with the most common being joint stiffness (10 cases; 1.03%), followed by lateral femoral condyle fracture (4;0.41%). The overall incidence of system-specific complications was 1.03%. Pin-related femoral fractures occurred in 0.2% of cases, all postoperatively and in the unicortical group. There was no statistically significant difference between the femoral pin insertion-related complication rates among the two groups (0.3% in the unicortical, compared to 0% in the bicortical group; p-value= 0.3). Complications included tibia fracture (0.1%), delayed wound healing (0.2%), superficial wound infection (0.1%), tibia osteomyelitis (0.1%), and “exostosis” (0.2%). The major complications rate was 0.3% and minor 0.7%. ConclusionsMinimal system-specific overall complications indicate that robotic arm-assisted surgery is safe. The bicortical diaphyseal femoral pin insertion method does not increase the complication rates compared to the unicortical metaphyseal method. Level of evidenceIII
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