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 safety and effectiveness of robotic-assisted TKA using the TSolution One Total Knee Application. This report details the findings from the IDE. Patients had to be ≥ 21 years old with BMI ≤ 40, Kellgren-Lawrence Grade ≥ 3, coronal deformity ≤ 20°, and sagital flexion contracture ≤ 15° to participate. In addition to monitoring all adverse events (AE), a pre-defined list of relevant major AEs (medial collateral ligament injury, extensor mechanism disruption, neural deficit, periprosthetic fracture, patellofemoral dislocation, tibiofemoral dislocation, vascular injury) were specifically identified to evaluate safety. 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. Results were compared to published values associated with manual TKA.Introduction
Methods
Total hip arthroplasty has seen a transition from cemented acetabular components to press-fit porous coated components. Plasma sprayed titanium implants are often press-fit with 1mm under-reaming of the acetabulum; however, as porous coating technologies evolve, the amount of under-reaming required for initial stability may be reduced. This reduction may improve implant seating due to lowered insertion loads, and reduce the risk of intraoperative fracture. The purpose of this study was to investigate the initial fixation provided by a high porosity coating (P2, DJO Surgical), and a plasma sprayed titanium coating under rim loading with line-to-line and 1mm press-fit surgical preparation. Five, 52mm high porosity acetabular cups (60% average porosity) and five 52mm plasma sprayed titanium coated cups were inserted into low density (0.24g/cc) biomechanical test foam (Pacific Research Laboratories). Foam test material was cut into uniform 90×90×40mm blocks. Reaming was performed using standard instrumentation mounted on a vertical mill. Cups were first inserted into foam blocks prepared with line-to-line (52mm) reaming. Following mechanical testing, cups were removed from the foam, cleaned, and inserted into foam blocks prepared with 1mm under reaming (51mm). In total 4 test conditions were evaluated:
Acetabular cup impaction was carried out using a single axis servohydraulic test machine (Instron 8500). Cups were inserted at 1mm/s to a load of 5kN. Insertion load was calculated as a 0.1mm offset from the linear portion of the force/displacement curve; insertion energy was the area under the curve. Tangential rim loading was applied at 0.0254mm/s by a conical indenter to the implant rim. Load data were recorded at 1kHz. Cup displacement was recorded by a 3D, marker-based tracking system at 15Hz (DMAS, Spicatek). Six markers were attached to a disk secured in the acetabular cup (Figure 1). Yield failure was defined as 0.331o of angular displacement (150µm of relative displacement). Angular displacement was derived by calculating the normal vector of a best-fit plane based on marker centroids.Introduction
Methods
