Active robotics for total knee Arthroplasty (TKA) uses a CAD-CAM approach to plan the correct size and placement of implants and to surgically achieve planned limb alignment. The TSolution One Total Knee Application (THINK Surgical Inc., Fremont, CA) is an open-implant platform, CT-based active robotic surgical system. A multi-center, prospective, non-randomized clinical trial was performed to evaluate the safety and effectiveness of robotic-assisted TKA using the TSolution One Total Knee Application. This report details the findings from the IDE. Inclusion criteria for patients receiving robotic TKA were: primary unilateral TKA; Kellgren-Lawrence OA grade 3 or 4; BMI < 40 kg/m2; coronal plane deformity < 20° varus; sagittal flexion contracture < 15°. In addition to monitoring all adverse events (AE), a pre-defined list of relevant major AEs were specifically identified to evaluate safety (Healy et al, 2013): medial collateral ligament injury; extensor mechanism disruption; neural deficit; periprosthetic fracture; patellofemoral dislocation; tibiofemoral dislocation; and vascular injury. Bleeding complications were also assessed. Malalignment rate, defined as the percentage of patients with more than a ± 3° difference in varus-valgus alignment from the preoperative plan, was used to determine accuracy of the active robotic system. Knee Society Scores (KSS) and Short Form 12 (SF-12) Health Surveys were assessed as clinical outcome measures. For each outcome, results were compared to published values associated with manual TKA.Introduction
Methods
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
