Gap balancing technique aims to achieve equal and symmetric gap at full extension and in flexion; however, little is known about the connection between the native and the replaced knee gaps. In this study, a novel robotic assisted ligament tensioning tool was used to measure the pre- and post- operative gaps to better understand their relationship when aiming for balance gaps in flexion and extension. The accuracy of a prediction algorithm for the post-operative gaps based on the native gap and implant alignment was evaluated in this study. The medial and lateral gap were smallest at full extension. The native gaps increase with flexion until 30 degrees where they plateaued for the remaining flexion range. The native lateral gap was larger than the medial gap throughout the flexion range. Planning for equal gaps at extension and flexion resulted with tightest gaps at these angle; however, the gaps in mid-flexion were 3–4 mm larger. Good agreement was observed between the post-operative results and the predicted gas from the software algorithm. The results showed that the native gaps are neither symmetric nor equal. In addition, aiming for equal gaps reduces the variation at these angles but could result in mid- flexion laxity. Advanced robotics-assisted instrumentation can aid in evaluation of soft-tissue and help in surgical planning of TKA. This allows the surgeon to achieve the targeted outcome as well as record the final implant tension to correlate with clinical outcomes.
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
Arthrofibrosis remains a dominant post-operative complication and reason for returning to the OR following total knee arthroplasty. Trauma induced by ligament releases during TKA soft tissue balancing and soft tissue imbalance are thought to be contributing factors to arthrofibrosis, which is commonly treated by manipulation under anesthesia (MUA). We hypothesized that a robotic-assisted ligament balancing technique where the femoral component position is planned in 3D based on ligament gap data would result in lower MUA rates than a measured resection technique where the implants are planned based solely on boney alignment data and ligaments are released afterwards to achieve balance. We also aimed to determine the degree of mechanical axis deviation from neutral that resulted from the ligament balancing technique. We retrospectively reviewed 301 consecutive primary TKA cases performed by a single surgeon. The first 102 consecutive cases were performed with a femur-first measured resection technique using computer navigation. The femoral component was positioned in neutral mechanical alignment and at 3° of external rotation relative to the posterior condylar axis. The tibia was resected perpendicular to the mechanical axis and ligaments were released as required until the soft tissues were sufficiently balanced. The subsequent 199 consecutive cases were performed with a tibia-first ligament balancing technique using a robotic-assisted TKA system. The tibia was resected perpendicular to the mechanical axis, and the relative positions of the femur and tibia were recorded in extension and flexion by inserting a spacer block of appropriate height in the medial and lateral compartments. The position, rotation, and size of the femoral component was then planned in all planes such that the ligament gaps were symmetric and balanced to within 1mm (Figure 1). Bone resection values were used to define acceptable limits of implant rotation: Femoral component alignment was adjusted to within 2° of varus or valgus, and within 0–3° of external rotation relative to the posterior condyles. Component flexion, anteroposterior and proximal-distal positioning were also adjusted to achieve balance in the sagittal plane. A robotic-assisted femoral cutting guide was then used to resect the femur according to the plan (Figure 2). CPT billing codes were reviewed to determine how many patients in each group underwent post-operative MUA. Post-operative mechanical alignment was measured in a subset of 50 consecutive patients in the ligament balancing group on standing long-leg radiographs by an independent observer. Post-operative MUA rates were significantly lower in the ligament balancing group (0.5%; 1/199) than in the measured resection group (3.9%; 4/102), p=0.051. 91.3% (42/46) of knees were within 3° and 100% (46/46) were within 4° of neutral alignment to the mechanical axis post-operatively in the ligament balancing group.Methods
Results
