RecruitingACTRN12622001169730

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.


Sponsor

Healthscope Australia

Enrollment

100 participants

Start Date

Mar 21, 2023

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Total knee replacement is one of the most commonly performed orthopaedic surgeries worldwide, and surgeons are always looking for ways to improve the accuracy of how the new knee joint is positioned. This study compares two approaches: the traditional method using physical guides and instruments called "jigs" to make the bone cuts, versus a newer method that uses a robotic arm (called ROSA) to assist the surgeon with greater precision. While early evidence suggests that robotic-assisted surgery may result in more accurate component positioning, it is not yet clear whether this accuracy actually translates into better outcomes for patients — meaning less pain, better movement, and greater satisfaction. This randomised trial aims to answer that important question. You may be eligible if you are 18 or older and are having your first knee replacement due to osteoarthritis (wear-and-tear arthritis). The study excludes people who are planning bilateral (both knees at once) replacements or two knee replacements within 6 months of each other, as that would complicate the comparison of outcomes.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Nepean Private Hospital - Kingswood

NSW, Australia

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ACTRN12622001169730