The use of accelerometer-based, computer navigation versus conventional alignment guides in achieving accurate implant position for Total Knee Replacement surgery

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Background: The KneeAlign 'Registered Trademark' is an accelerometer-based, electronic, portable device which was designed for use in navigational total knee arthroplasty. There is literature which supports its efficacy and safety in achieving satisfactory knee alignment following total knee arthroplasty. However, most studies on the device has come from the designer unit and further information gathered from independent operators will be important. Its potential benefit is in the area of navigated arthroplasty as it is less-bulky than current navigation equipment and may prove important in complex surgeries where navigation is most useful. The risks are minimal and may even protect the medullary canal (as this is invaded using conventional alignment guides). The patient receives the same implant by the same surgeon and this device is to be used solely as an aid in achieving accurate bony cuts during surgery. This study will compare conventional guides and the navigation device in question. The trial will be conducted in compliance with the protocol laid out, GCP and the ethics regulations. The study will look at patients who are undergoing routine total knee replacement for osteoarthritis (the most common reason for prosthetic replacement). Trial Objectives: To prospectively compare patient-reported outcome measures and radiological results between conventionally guided and accelerometer-based navigation in patients undergoing total knee replacement surgery. Specifically, we will compare pain and functional scores together with mechanical axes correction in both sagittal and coronal planes. trial will be a prospective, patient-blinded, randomised comparative study with the end-points being patient-reported outcome measures, radiological results and duration of surgery. Patient consent and ethical approval will be obtained prior to trial commencement. Clinical outcome measures would be assessed via the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome score (KOOS) questionnaires which are both validated patient reported outcome measures following knee arthroplasty. These questionnaires will be taken at the time of standard appointments (pre-surgery & 6 months). Radiological outcomes will be assessed via CT imaging studies pre and post op using the CT Perth Protocol (To assess for mechanical & anatomical alignment). Patients will be recruited at the time when a decision to proceed with a knee arthroplasty is made during consultation.

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