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. 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.Objectives
Materials and Methods
