Does the use of the Verasense pressure sensor device and alignment method produce a more balanced knee in patients undergoing total knee arthroplasty

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The primary aim of this project is to determine the influence of two different prosthesis alignment techniques in total knee arthroplasty (TKA) on the soft tissue balance of the knee by using a novel pressure sensor device. Our hypothesis is, that the kinematic alignment of a total knee prosthesis creates a more balanced knee without the need for soft tissue releases. The secondary aim of the project is to determine what relationship prosthesis alignment technique has on patient satisfaction and on patient reported outcome measures (PROMs). The proposed research design is a multi-site, single blinded, prospective randomized controlled trial involving four consultant orthopaedic surgeons at the Mater Health Services North Queensland Ltd, Cairns Base Hospital and the Cairns Private Hospital. Participants will be randomized to either mechanical or kinematic alignment. All participants will undergo the same peri-operative and post-operative protocol process for TKA. All procedures will be planned and performed with the use of patient specific instrumentation (PSI) custom cutting guides based on a pre-operative MRI. These allow the surgeon to make pre-planned bone resections specific to the participant's anatomy. All participants will receive the same total knee prosthesis. The surgical technique will be standardized with respect to the resection of bone, ligament tension assessment and the use of Verasense instrumentation. The Verasense insert will be used intra-operatively to measure pressures across the knee joint during the prosthesis trialing phase, before any soft tissue releases are performed. If the knee is not balanced, then measured steps will be undertaken to achieve balance. All intra-operative surgical data will be recorded. Post-operative patient review will be conducted at two weeks, six weeks, six months, and then yearly. Standard TKA post-operative radiologic assessment will be undertaken to determine the final prosthesis alignment. Outcome measures will include validated clinical pain and function scores such as the WOMAC score, EQ5D, Knee Society Score, the Oxford Knee Score, and the Forgotten Joint Score. Data collected will be analysed using statistical methods in order to find any statistically significant difference in results between the two alignment strategies. Once collected, data will be de-identified (non-identifiable) and sent to an external statistician to perform statistical analysis. All participants will receive PSI Zimmer Nexgen CR Flex TKA prosthesis.