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

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Abstract

Abstract Around 2–20% of patients who undergo total knee arthroplasty (TKA) reported restricted motion and anterior knee pain. Non-optimal implant components alignment represents a common cause for complain. In this context, the introduction of robotic assisted TKA is supposed to improve the accuracy of component positioning and to adapt more precisely to patient anatomy and biomechanics. Robotic TKA using has been introduced to improve component alignment, stability and proprioception. However, the advantages of robotic surgery over the conventional freehand TKA are still unclear and evidence are missing. The present study is a protocol for a single-blind parallel-group randomized controlled trial in which each group of participants is exposed to only one of the study interventions. Patients will be randomly allocated to robotic TKA or standard TKA. The primary outcome of interest is to evaluate the learning curve. The secondary outcome of interest is to compare robotic TKA using CORI versus freehand arthroplasty in patients reported outcome measures (PROMs), length of the hospitalisation, blood values, implant positioning, blood transfusion units, range of motion. The third outcome of interest is to evaluate accuracy of component positioning of robotic TKA compared to the conventional TKA with respect to the pre-operative planning. Level of evidence: Level I, randomised controlled trial Registration: German Registry of Clinical Trials (ID: DRKS00030614)

Authors 7

1. Filippo Migliorini Aachen

   University of Salerno · RWTH Aachen University

   Affiliation as printed

   RWTH University Hospital

   University of Salerno

2. Nicola Maffulli Aachen

   University of Salerno · RWTH Aachen University

   Affiliation as printed

   University of Salerno

   RWTH University Hospital

3. Luise Schäfer Aachen

   University of Salerno · RWTH Aachen University

   Affiliation as printed

   RWTH University Hospital

   University of Salerno

4. Jens Schneider Aachen

   University of Salerno · RWTH Aachen University

   Affiliation as printed

   RWTH University Hospital

   University of Salerno

5. Andrea Maria Nobili Aachen

   University of Salerno · RWTH Aachen University

   Affiliation as printed

   Eifelklinik St.Brigida

   RWTH University Hospital

   University of Salerno

6. Daniel Kämmer Aachen

   University of Salerno · RWTH Aachen University

   Affiliation as printed

   Eifelklinik St.Brigida

   RWTH University Hospital

   University of Salerno

7. Milosch Michalak Aachen

   University of Salerno · RWTH Aachen University

   Affiliation as printed

   Eifelklinik St.Brigida

   RWTH University Hospital

   University of Salerno