None listed
Conditions
Brief 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.
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 a
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.
Sponsors
Healthscope Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Population The study population will include individuals aged greater than or equal to 18 years presenting to participating surgeons for TKR due to knee osteoarthritis (OA). Inclusion criteria • Primary TKR surgery secondary to OA • Able to provide informed consent in English
Exclusion criteria
Exclusion criteria • Simultaneous bilateral TKR or planned sequential TKR within 6 months of each other.
Outcome results
None listed