We introduce a novel active tensioning system that can be used for dynamic gap-based implant planning as well as for assessment of final soft tissue balance during implant trialing. We report on the concept development and preliminary findings observed during early feasibility testing in cadavers with two prototype systems. The active spacer (fig 1) consists of a motorized actuator unit with integrated force sensors, independently actuated medial and lateral upper arms, and a set of modular attachments for replicating the range of tibial baseplate and insert trial sizes. The spacer can be controlled in either force or position (gap) control and is integrated into the OMNIBoticsTM Robotic-assisted TKA platform (OMNI, MA, USA). Two design iterations were evaluated on eleven cadaver specimens by seven orthopaedic surgeons in three separate cadaver labs. The active spacer was used in a tibial-first technique to apply loads and measure gaps prior to and after femoral resections. To determine the range of forces applied on the spacer during a varus/valgus assessment procedure, each surgeon performed a varus/valgus stress test and peak medial and lateral forces were measured. Surgeons also rated the feel of the stability of the knee at 50N and 80N of preload using the following scale: 1 – too loose; 2 – slightly loose; 3 – ideal; 4 slightly tight; 5 – too tight. Final balanced was assessed with the spacer and with manual trial components.System description
Cadaver Study
Knee instability, stiffness, and soft-tissue imbalance are causes of aseptic revision and patient dissatisfaction following total knee arthroplasty (TKA). Surgical techniques that ensure optimal ligament balance throughout the range of motion may help reduce TKA revision for instability and improve outcomes. We evaluated a novel tibial-cut first gap balancing technique where a computer-controlled tensioner is used to dynamically apply a varying degree of distraction force in real-time as the knee is taken through a range of motion. Femoral bone cuts can then be planned while visualizing the predicted knee implant laxity throughout the arc of flexion. After registering the mechanical axes and morphology of the tibia and femur using computer navigation, the tibial resection was performed and a robotic tensioning tool was inserted into the knee prior to cutting the femur. The tool was programmed to apply equal loads in the medial and lateral compartments of the knee, but to dynamically vary the distraction force in each compartment as the knee is flexed with a higher force being applied in extension and a progressively lower force applied though mid-flexion up to 90° of flexion. The tension and predictive femoral gaps between the tibial cut and the femoral component in real-time was determined based on the planned 3D position and size of the femoral implant and the acquired pre-resection gaps (figure 1). Femoral resections were then performed using a robotic cutting guide and the trial components were inserted.Introduction
Surgical Technique Description
