64 Participants Needed

Robot-Assisted vs Standard Knee Replacement for Osteoarthritis

(RoboKnees Trial)

KM
Overseen ByKim Madden, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is robot-assisted knee replacement surgery safe for humans?

Research shows that robot-assisted knee replacement surgery is generally safe, with studies focusing on its accuracy and precision compared to traditional methods. These studies have not reported significant safety concerns, indicating it is a safe option for knee replacement.12345

How does robot-assisted knee replacement differ from standard treatments for osteoarthritis?

Robot-assisted knee replacement is unique because it uses robotic technology to improve the accuracy of implant positioning and alignment during surgery, which can lead to better short-term functional outcomes and more precise component placement compared to conventional methods.46789

What data supports the effectiveness of the treatment Robot-assisted partial knee arthroplasty and Total knee arthroplasty for osteoarthritis?

Research shows that robot-assisted knee surgeries, like total and partial knee arthroplasty, improve the accuracy of implant positioning and alignment compared to traditional methods. This can lead to better short-term functional outcomes, especially in partial knee replacements, although the long-term benefits are still being studied.346810

Who Is on the Research Team?

AA

Anthony Adili, MD, P.Eng, FRCSC

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for adults with unicompartmental knee osteoarthritis, potentially including patellofemoral OA, who need surgery. Candidates must be agreed upon by two study surgeons as eligible for either treatment. Exclusions include prior major knee surgery, inability to get a CT scan before surgery, technical issues with the robot equipment, cognitive disabilities preventing informed consent, and those not wishing to participate.

Inclusion Criteria

I need surgery for knee arthritis affecting one part of my knee.
Two surgeons agree I am eligible for the study's treatment options.

Exclusion Criteria

Inability to provide informed consent (e.g. cognitive disability, language barrier)
I have had major knee surgery or experienced significant knee trauma.
I am scheduled for or have had a knee surgery revision.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robot-assisted partial knee arthroplasty or standard total knee arthroplasty

6 weeks
Multiple visits for surgery and initial recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of knee function and quality of life

12 months
Regular follow-up visits for assessments

Long-term follow-up

Participants are monitored for long-term outcomes such as implant survival and persistent post-surgical pain

12 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

  • Robot-assisted partial knee arthroplasty
  • Total knee arthroplasty
Trial Overview The study is comparing robot-assisted partial knee replacements with standard total knee replacements in patients with osteoarthritis. It's a pilot randomized trial designed to see if a larger definitive trial would be feasible to determine which surgical method is more effective.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Robot-assisted partial knee arthroplastyExperimental Treatment1 Intervention
Participants with isolated medial or isolated lateral compartment OA who are randomized to the intervention group and have one affected knee compartment will receive a robot-assisted unicompartmental knee arthroplasty (UKA). If the patient has medial or lateral OA plus patellofemoral OA they will receive a bicompartmental knee arthroplasty (BiKA) consisting of a two simultaneous UKAs. The partial knee replacement procedures will be performed using the Mako RIO robotic arm (Stryker) according to the manufacturer's instructions. The choice of implant and use of bone cement will be recorded but will be left to the surgeon's discretion. Surgeons will resurface the patella if the patellar cartilage meets Outerbridge grade 3 or 4 criteria
Group II: Standard total knee arthroplastyActive Control1 Intervention
Participants who are randomized to the control group will undergo TKA according to local standard of care. The choice of implant and use of bone cement will be recorded but left to the surgeon's discretion according to their standard practice.

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Hamilton Academic Health Sciences Organization

Collaborator

Trials
22
Recruited
5,200+

St. Joseph's Healthcare Hamilton

Collaborator

Trials
203
Recruited
26,900+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Published Research Related to This Trial

In a study of 46 patients undergoing robotic-assisted total knee arthroplasty, significant improvements were observed in knee function, with Oxford scores increasing from an average of 18.5 to 43.5 for the right knee and from 16.9 to 43.4 for the left knee post-surgery.
The Knee Society Scores (KSS) also showed substantial enhancement, rising from 49.7 to 89.2 for the right knee and from 46.5 to 89.8 for the left knee, indicating that robotic assistance in knee surgery can lead to effective functional outcomes.
A novel robot-assisted knee arthroplasty system (ROSA) and 1-year outcome: A single center experience.Demirtas, Y., Emet, A., Ayik, G., et al.[2023]

Citations

Robot-assisted total knee arthroplasty improves mechanical alignment and accuracy of component positioning compared to the conventional technique. [2022]
Robot-assisted surgery in total knee arthroplasty: trauma maker or trauma savior? A prospective, randomized cohort study. [2022]
Early Clinical and Radiographic Outcomes of Robot-Assisted Versus Conventional Manual Total Knee Arthroplasty: A Randomized Controlled Study. [2022]
[A comparative study of short-term effectiveness of "SkyWalker" robot-assisted versus traditional total knee arthroplasty]. [2023]
Robot-Assisted versus Conventional Total and Unicompartmental Knee Arthroplasty: A Meta-analysis of Radiological and Functional Outcomes. [2022]
Clinical evaluation of the first semi-active total knee arthroplasty assisting robot made in China: a retrospective propensity score-matched cohort study. [2023]
Robotic-arm assisted total knee arthroplasty is associated with comparable functional outcomes but improved forgotten joint scores compared with conventional manual total knee arthroplasty at five-year follow-up. [2023]
[A multicenter randomized controlled trial of domestic robot-assisted and conventional total knee arthroplasty]. [2023]
A novel robot-assisted knee arthroplasty system (ROSA) and 1-year outcome: A single center experience. [2023]
[ROBOTICS- WHY NOW?] [2021]
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