Robotic assisted vs instrumented total knee replacement (TKR): a single-blind randomised controlled clinical trial.
Robotic Surgical assisted (ROSA) vs instrumented total knee replacement (TKR): a single-blind randomised controlled clinical trial assessing the effect of TKR-ROSA and TKR-Jigs on patient-reported index knee pain and function in the operated joint using the Oxford Knee Score (OKS) at 52 weeks.
Healthscope Australia
100 participants
Mar 21, 2023
Interventional
Conditions
Summary
The purpose of this study is to assess if the use of a robotic arm during TKR surgery results in better patient outcomes compared to the conventional method of using company instruments (jigs). In recent years there have been many technological advancements to help surgeons be more accurate in how they put in the components during TKR. The most recent advancement is the development of a robotic arm (ROSA) that assists the surgeon in performing the bony cuts required during surgery before putting in the components of the TKR. Traditionally, this part of the procedure has been performed with the help of company instruments called jigs. While the accuracy of component implantation may be better with the use of the robotic arm, we still do not know if the use of the robotic arm means better patient outcomes compared to the standard method of using company instruments (jigs) in TKR.
Eligibility
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Interventions
In this single-site, multi-surgeon trial, 100 people (50 in each arm) with knee osteoarthritis will be randomized to undergo unilateral total knee replacement (TKR) surgery at Nepean Private Hospital (NPH) either with the assistance of a robotic arm (ROSA) (TKR-ROSA) or with the conventional method of using standard company manufactured instruments (jigs) (TKR-Jigs). Nepean Private Hospital is a high-volume arthroplasty centre and participating surgeons are experienced with subspeciality knee arthroplasty training and at least eight years of post-fellowship experience. Surgeons participating in this study already routinely use TKR ROSA. The procedure time for TKR jigs and TKR ROSA are no different, 60-120mins.
Locations(1)
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ACTRN12622001169730