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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

RoboKnees Trial 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.Check my eligibility
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.See study design
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.

RoboKnees Trial 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.

RoboKnees 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

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

RoboKnees 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
881 Previous Clinical Trials
2,597,826 Total Patients Enrolled
19 Trials studying Osteoarthritis
901,066 Patients Enrolled for Osteoarthritis
St. Joseph's Healthcare HamiltonOTHER
196 Previous Clinical Trials
25,480 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes are the researchers hoping to achieve with this medical experiment?

"During this 12 month clinical trial, the main objective is to determine participant retention. Secondary goals comprise of measuring knee function with the Oxford Knee Score (OKS), assessing time to return to unrestricted activities utilizing a 5-item Return To Function questionnaire, and evaluating patient's individual impressions on treatment efficacy through The Patient Global Impression of Change scale."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
65+
What site did they apply to?
St. Joseph's Healthcare Hamilton
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement
2020. "Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04378049.
All > Knee Replacement
~9 spots leftby Dec 2024
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