← Back to Search

Robotic Surgery

Robot-Assisted vs Standard Knee Replacement for Osteoarthritis (RoboKnees Trial)

N/A
Recruiting
Led By Anthony Adili, MD, P.Eng, FRCSC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unicompartmental knee OA with or without concomitant patellofemoral OA, requiring surgical treatment
Be older than 18 years old
Must not have
Previous major knee surgery or trauma
Revision knee surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial is testing whether robot-assisted partial knee replacements are better than standard total knee replacements.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, common risks associated with knee replacement surgeries may include pain at the site of operation, infection risk post-surgery, blood clots in leg veins or lungs (embolism), stiffness or limited range of motion in the joint.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need surgery for knee arthritis affecting one part of my knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had major knee surgery or experienced significant knee trauma.
Select...
I am scheduled for or have had a knee surgery revision.
Select...
I am having surgery on both knees at the same time.
Select...
I do not want to join the clinical trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility- Participant retention
Feasibility- Recruitment
Feasibility- Treatment compliance
Secondary study objectives
Adverse events
Forgotten joint score
Gait walking mechanics analysis
+9 more

Trial Design

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 Location

Who is running the clinical trial?

Hamilton Academic Health Sciences OrganizationOTHER
20 Previous Clinical Trials
4,802 Total Patients Enrolled
McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,613,177 Total Patients Enrolled
19 Trials studying Osteoarthritis
901,066 Patients Enrolled for Osteoarthritis
St. Joseph's Healthcare HamiltonOTHER
199 Previous Clinical Trials
26,617 Total Patients Enrolled

Media Library

Robot-assisted partial knee arthroplasty (Robotic Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04378049 — N/A
Osteoarthritis Research Study Groups: Robot-assisted partial knee arthroplasty, Standard total knee arthroplasty
Osteoarthritis Clinical Trial 2023: Robot-assisted partial knee arthroplasty Highlights & Side Effects. Trial Name: NCT04378049 — N/A
Robot-assisted partial knee arthroplasty (Robotic Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04378049 — N/A
~3 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top