Abstract
Objectives
Successful total knee arthroplasty (TKA) is predicated on accurate bony resection, mechanical alignment and component positioning. An active robotic TKA system is designed to achieve reliable and accurate bony resection based upon a preoperatively developed surgical plan. Surgical resections are executed intra-operatively according to this pre-operative plan. The goal of this study was to determine the accuracy of final implant positioning and alignment using this active robotic device, as well as its early clinical outcomes.
Materials and Methods
An FDA prospective study under investigational device exemption was conducted from 2017–2018. Pre-operative CT scans were used to create a pre-operative plan using the TSolution One? Surgical System (THINK Surgical, Inc). TKA was performed using a standard approach, with planned and robotically executed femoral and tibial resections. Subjects completed 3-month follow-up with post-operative CT scans. A validated method was used to compare pre- and post-operative CT scans to determine differences between planned and achieved implant position. Femoral and tibial component sizing, and mean differences in implant position and alignment were compared. Short Form 12 Physical (PCS) and Mental Component Summary (MCS) scores as well as Knee Society (Objective and Functional) scores at 12 weeks post-operatively were compared with pre-operative scores. Paired-sample t-tests were used for comparisons.
Results
Fifty-five subjects whom underwent active robotic TKA and completed 3-month follow-up and were included for analysis. Proximal-distal, antero-posterior and varus-valgus translations, and flexion-extension, internal-external rotations for the FEMUR were statistically different from plan, but the differences were small (<1.7mm, <0.6 deg- p<0.04 for all) and of no clinical significance. The proximal-distal and flexion-extension rotational alignment were also statistically different for the TIBIA but clinically minimal (<0.7 mm, p<0.005). There was no difference in hip-knee angle between planned and post-operative measurements (0 ± 2 degrees p=0.900). No infections, neurovascular, tendon or ligament injuries or fractures were identified. There were no differences in femoral sizing in any case, and 3 tibial components differed by one size. Furthermore, SF-12 PCS and Knee Society (Objective and Functional) scores all statistically improved from pre-operatively to 12 weeks post-operatively (p<0.001 for all), however SF-12 MCS did not improve at 12-weeks (p=0.600).
Conclusion
The findings of this early clinical study suggest minimal deviations in final implant position from the pre-operative plan, with improvements in clinical outcome scores and no complications in early follow-up.
