Does Soft Tissue Balancing Using Intra-Operative Pressure Sensors Improve Clinical Outcomes in Total Knee Arthroplasty? A Multi-Centre Randomised Controlled Trial

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Total knee arthroplasty (TKA), or total knee replacement surgery, is a successful operation in alleviating pain and improving function for the majority of people with end-stage knee osteoarthritis. However, up to 20% of patients undergoing TKA report some dissatisfaction following their surgery. Dissatisfaction after TKA is multi-factorial, but the surgical causes are commonly related to imbalance of the ligaments (soft tissues) that surround the knee at the time of surgery or slight malalignment of the upper and lower leg bones. Current thinking in the field of total knee replacement centres around optimising the balance of the ligaments as the prostheses are implanted, because it is generally agreed that this equilibrium is associated with the best outcomes for patients. Traditionally, surgeons have decided whether a knee is balanced during surgery by using their experience to manually assess the feel of the joint. Other methods used to balance the knee have involved measuring the space between the femur (thigh bone) and tibia (shin bone) based on ligament tensioning and using computer navigation to assess the stresses across the joint. Since the introduction of wireless sensor technology, surgeons have another tool to measure soft tissue balance and the ways in which the bones move against each other. Intra-operative pressure sensors use micro-electronics to calculate pressure loads in the compartment between the femur and tibia as the knee is bent and straightened out. Surgeons can use this information to appropriately align the implants for optimum balance. The intra-operative device used in this study is called the Verasense pressure monitor, and it is used by some surgeons in knee replacements operations outside this study. It is important to state that there has been no rigorous research to date that shows an association between using the Verasense device and better outcomes such as less pain, more function and overall satisfaction. The aim of this study is to investigate whether there are such benefits to using intra-operative sensors to achieve balance. Participants will be randomly assigned to either a manual balancing (MB) group or a sensor-guided balancing (SGB) group. For patients in the MB group, surgeons will use standard methods to achieve soft tissue balance. For patients in the SGB group, surgeons will use readings from the Verasense device to achieve soft tissue balance. Participants will be followed closely over the course of two years to monitor the progress in each group. The results of this trial will aim to inform future clinical practice with regard to soft-tissue balance and alignment in total knee arthroplasty

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