A prospective randomised controlled trial of mechanical axis with soft tissue release balancing vs functional alignment with bony resection balancing in total knee replacement—a study using Stryker Mako robotic arm-assisted technology

BACKGROUND: Improving the functional outcome following total knee arthroplasty (TKA) by using different alignment techniques remains controversial. The surgical techniques and technologies used so far to obtain these alignments have all suffered from inaccuracies. The use of robotic technology to plan and execute the bony resection provides increased accuracy for these various alignment techniques and may determine which will deliver superior function. Functional alignment (FA) is a newer surgical technique that aims to position the prosthesis with respect to each patients’ specific bony anatomy whilst minimising disruption to the soft tissue envelope. This trial aims to compare the patient and surgical outcomes of FA to the current gold standard surgical technique, mechanical alignment (MA), under randomised and blinded conditions. METHODS: Patients with symptomatic knee osteoarthritis will be prospectively recruited. Following informed consent, 240 patients will be randomised to either a MA surgical technique (the control group) or a FA surgical technique (the intervention group) at a ratio of 4:1 using a random number generator. All patients will undergo computer tomography (CT) based robotic arm-assisted surgery to execute planned implant positioning and alignment with high levels of accuracy. The primary outcome is the forgotten joint score (FJS) at 2 years post-operation. Secondary outcome measures include patient reported outcome measures of post-operative rehabilitation, pain, function and satisfaction, as well as limb alignment, implant revisions and adverse events. Intention-to-treat and per-protocol population analysis will also be conducted. Standardisation of the surgical system and care pathways will minimise variation and assist in both patient and physiotherapist blinding. Ethical approval was obtained from the Northern B Health and Disability Ethics Committee (20/NTB/10). DISCUSSION: Currently, MA remains the gold standard in knee replacement due to proven outcomes and excellent long-term survivorship. There are many alternative alignment techniques in the literature, all with the goal of improving patient outcomes. This study is unique in that it leverages an advanced analytics tool to assist the surgeon in achieving balance. Both alignment techniques will be executed with high precision using the CT-based robotic arm-assisted surgery system which will minimise surgical variation. This trial design will help determine if FA delivers superior outcomes for patients. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000009910. Registered on 9 January 2020. ClinicalTrials.gov, NCT04600583. Registered on 29 September 2020.