Surgical navigation has been shown to improve the accuracy of bone preparation and limb alignment in total knee arthroplasty (TKA). Previous work has shown the effectiveness of various types of navigation systems. Here, for the first time, we assessed the accuracy of a novel imageless semiautonomous handheld robotic sculpting system in performing bone resection and preparation in TKA using cadaveric specimens. In this study, we compared the planned and final implant placement in 18 cadaveric specimens undergoing TKA using the new tool. Eight surgeons carried out the procedures using three types of implant designs. A quantitative analysis was performed to determine the translational, angular, and rotational differences between the planned and achieved positions of the implants. The mean femoral flexion, varus/valgus, and rotational error was −2.0°, −0.1°, and −0.5°, respectively. The mean tibial posterior slope, and varus/valgus error was −0.2°, and −0.2°, respectively. We obtained higher flexion errors for the femoral implant when using cut-guides as compared to using a bur for cutting the bones. The image-free robotic sculpting tool achieved accurate implementation of the surgical plan with small errors in implant placement. Future studies will focus on determining how well the accurate implant placement translates into a clinical and functional benefit for the patient.

Introduction Total knee arthroplasty (TKA) is the gold standard for treatment of end-stage osteoarthritis. Previous studies have shown that successful outcomes following TKA depend on accurate implant alignment and soft tissue balancing. Robotic-assisted TKA have demonstrated improved accuracy in component placement and have been associated with better outcomes and patient satisfaction. This study aims to report on the execution accuracy of two generations of handheld robotic-assisted surgical systems. Methods This was a retrospective analysis of TKA procedures with two sequential generations of the same handheld roboticassisted surgical system. Intra-operative data captured included pre-operative limb deformity, limb axes, range of motion, kinematic balance, and the resulting plan for component placement in three-dimensional space. Patients were stratified based on their preoperative coronal lower limb mechanical alignment (> 3° varus, < 3° varus, < 3° valgus, and ≥ 3° valgus). Measurements of component placement (overall lower limb alignment, medial and lateral flexion gaps, and tibial and femoral resection depths) were assessed using descriptive statistics. Results A total of 435 patients were included and stratified based on preoperative lower limb alignment: 229 with ≥ 3° varus, 78 with varus < 3° and 58 with valgus < 3°, and 70 with valgus > 3°. The mean difference between planned and achieved alignment in the lower limb valgus patients was < 1° across all groups. Mean differences between planned and achieved medial flexion gap was higher in the > 3° subgroup in the varus patient cohort ([< 3°]: 1.15 ± 1.92 vs. [> 3°]: 1.90 ± 2.57); this value was higher in the < 3° subgroup for valgus patients ([< 3°]: 1.34 ± 1.83 vs. [> 3°]: 0.956 ± 1.65). Average resection depth ranged from 9.46 to 10.4 mm in the posterior medial femur, 9.25 to 9.95 mm in the posterior lateral femur, 7.45 to 8.79 mm in the distal medial femur, 8.22 to 9.18 mm in the distal lateral femur, 6.70 to 7.07 mm in the medial tibial condyle and 6.40 to 7.19 mm in the lateral tibial condyle. Non-inferiority testing demonstrated the newer generation is non-inferior to the older generation. Conclusion Robotic-assisted knee replacement using handheld image-free systems is able to maintain accuracy of component placement. Further investigation of patient reported outcomes as well as long-term implant longevity are needed.

Bi-cruciate retaining knee implants are anatomically designed for use in early surgical intervention, for patients with less severe arthritic disease. Patient satisfaction after total knee replacement is directly related to knee stability and proprioception, particularly for high-demand, active patients. While preservation of all intact and healthy ligaments may be the key to achieving such results of satisfaction, balancing four ligaments in a bi-cruciate procedure is more technically challenging then a conventional total knee replacement. Robotics-assisted arthroplasty has been gaining popularity as a tool to increase accuracy and precision of implant positioning. Robotics-assisted systems can provide surgeons with virtual tools to make informed decisions for knee replacement, specific to the needs of the patient. Here, we are introducing a semiautonomous handheld robotic system support for a bi-cruciate retaining knee implant design. The system supports image-free anatomic data collection and streamlined intraoperative surgical planning with dynamic gap balancing before any bone preparation. In this study, we evaluate the surgical technique and accuracy of implant placement in synthetic bone and cadaver experiments.

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