Robotic-assisted total knee arthroplasty in clinical practice: protocol for a randomised controlled trial

Between 2 and 20% of patients who undergo total knee arthroplasty (TKA) report restricted motion and anterior knee pain. Non-optimal alignment of the implant components is a common cause of such complaints. Robotic-assisted TKA has been advocated to improve the accuracy of component positioning to match patients’ anatomy and biomechanics. However, the advantages of robotic surgery over conventional freehand TKA are still unclear. The present study is a protocol for a single-blind clinical trial in which patients will be randomly allocated to undergo either robotic-assisted TKA or conventional freehand TKA. A restricted kinematic alignment with medial para-stellar approach shall be made in all patients. The present study follows the SPIRIT guidelines. The primary outcome of interest is to compare robotic TKA versus traditional freehand TKA in terms of patient-reported outcome measures (PROMs), length of hospitalisation, blood values, blood transfusion units, and range of motion. The second outcome of interest is to evaluate the accuracy of component positioning of robotic-assisted TKA compared to the conventional freehand TKA. Level of evidence Level I, randomised controlled trial. Registration German Registry of Clinical Trials (ID: DRKS00030614). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13018-023-04101-z.