Randomized Controlled Trial And Learning Curve Analysis Of Robot-assisted Total Knee Arthroplasty Compared With Conventional Total Knee Arthroplasty

Background:Total knee arthroplasty(TKA)is an excellent treatment for patients with advanced knee arthritis.Improving prosthesis positioning and gap balance is an important goal of total knee arthroplasty,and theoretically,robot-assisted surgery can effectively help clinicians achieve this goal.In recent years,the reports on robot assisted surgery has gradually increased.Robot-assisted total knee surgery systems,such as Robodoc(Curexo Technology),Mako(Stryker),and Navio(Smith&Nephew)systems,have been proven to have good surgical results and clinical prognosis.There have also been reports on the learning curve in their application process.However,the ROSA robot-assisted knee arthroplasty system developed by Zimmer-Biomet Company in the United States was later applied in clinical practice,and there are few reports of clinical research related to it.Objective:A randomized controlled clinical trial was conducted to investigate whether there are differences in prosthetic position and postoperative lower limb alignment between ROSA robot-assisted TKA and conventional TKA,whether there are differences in various clinical indicators during the perioperative period,and whether there are differences in various follow-up indicators after surgery;Explore the accuracy and stability of cutting with ROSA robot-assisted system;Collect and analyze the learning curve of the ROSA robot-assisted system.Methods:According to the inclusion and exclusion criteria,a total of 50 patients who were scheduled to undergo TKA surgery for knee arthritis at Shandong Provincial Hospital from September 2021 to September 2022 were randomly divided into 25 robot-assisted TKA surgery groups(the experimental group)and 25 conventional TKA surgery groups(the control group).The experimental group received ROSA robot-assisted TKA surgery,while the control group received conventional TKA surgery.Finally,45 patients were included in the statistical analysis,with 22 patients in the experimental group and 23 patients in the control group.Collect various perioperative and follow-up data of the two groups of patients,and statistically analyze the above data through SPSS26.0.P<0.05 indicates a statistically significant difference;The learning curve was obtained by analyzing the data of 17 patients undergoing ROSA robot-assisted TKA surgery performed by the same surgeon using the cumulative summation(CU SUM)method.Results:There were no significant statistical differences between the two groups in baseline data such as age,gender,height,weight,BMI,and ASA grading.The operation time and tourniquet time of patients in the robot-assisted TKA group were significantly prolonged(p<0.05),and there was no statistically significant difference in hospital stay and perioperative blood loss between the two groups(p>0.05);The average range of motion(ROM)of patients in the robot-assisted TKA group was 112.75 °±10.90° in the first month after surgery,compared with 108.54 °± 13.63 ° in the conventional TKA group,there was no statistically significant difference between the two groups(p>0.05);There was no statistically significant difference in KSS knee score,KSS functional score,HSS score,and VAS score between the two groups 1 month after surgery(p>0.05);The postoperative HKA angle of patients in the robot-assisted TKA group was 179.04 °±2.22 °,compared to 179.20°± 2.25° in the conventional TKA group,there was no statistically significant difference between the two groups(p>0.05);In the robot-assisted TKA group,there was no statistically significant difference between the actual cutting angle and the planned cutting angle for each part(p>0.05),with a difference of less than 3 ° accounting for more than 95.5%;The difference between the actual cutting thickness and the planned cutting thickness of the lateral posterior condyle of the femur was 0.71±1.29 mm(p<0.05),while the difference between the other parts was not statistically significant(p>0.05),with the difference of less than 2 mm accounting for>85%;The inflection point of the learning curve obtained by using the CUSUM method is located around the 10th surgery,with the 1-10 surgery being the learning stage,and the 11-17 surgery being the proficiency stage.Conclusion:Robot-assisted TKA surgery can obtain good lower limb alignments,and its short-term prognosis is not significantly different from conventional TKA surgery.The robot-assisted system has a small difference between actual cutting and planned cutting,and has good accuracy and stability.The learning curve of the robot-assisted system requires 10 surgeries to complete the learning stage.Clinicians can attempt to perform related surgery based on the learning curve in this study.