Robot-Assisted vs Standard Knee Replacement for Osteoarthritis
(RoboKnees Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two types of knee surgeries for individuals with osteoarthritis, a joint disease causing pain and stiffness. It compares robot-assisted partial knee replacements (robot-assisted partial knee arthroplasty) to standard full knee replacements (total knee arthroplasty) to determine which is more effective. Participants should have knee osteoarthritis affecting one part of the knee and require surgery. This study suits those who have struggled with knee pain and are considering surgical options. As an unphased trial, it offers a unique opportunity to explore innovative surgical options for knee osteoarthritis.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that robot-assisted partial knee replacements are generally safe and well-tolerated. Studies comparing robotic knee surgeries to traditional methods find similar outcomes in movement and pain relief, indicating that the robotic approach does not increase risks compared to standard procedures.
A review of several studies found that robotic surgery might improve movement and function compared to manual surgery. However, robotic surgeries may take slightly longer to complete. Despite the additional time, safety remains comparable to traditional surgeries, with no significant increase in reported side effects.12345Why are researchers excited about this trial?
Researchers are excited about robot-assisted partial knee arthroplasty because it offers a high-tech twist on traditional knee replacement surgeries, potentially enhancing precision and outcomes. Unlike standard total knee arthroplasty, this method uses a robotic arm, specifically the Mako RIO by Stryker, to assist surgeons in performing more accurate and tailored procedures. This precision could lead to better alignment and less damage to surrounding tissues, which might translate to faster recovery times and improved joint function for patients with osteoarthritis. By focusing on the specific compartments of the knee that are affected, this technique can be less invasive compared to replacing the entire knee, offering a targeted approach that standard procedures can't match.
What evidence suggests that this trial's treatments could be effective for osteoarthritis?
This trial will compare robot-assisted partial knee arthroplasty with standard total knee arthroplasty for osteoarthritis. Research has shown that using robots in partial knee replacement surgery can lead to better outcomes for people with osteoarthritis. Studies have found that this robotic method often improves knee function and increases patient satisfaction compared to traditional surgery. A review of multiple studies found that the robotic technique significantly enhances knee performance after surgery. Patients report feeling less aware of the joint and experiencing a smoother return to daily activities. Long-term research indicates high satisfaction rates and that the new joint lasts longer with fewer problems.12346
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either robot-assisted partial knee arthroplasty or standard total knee arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of knee function and quality of life
Long-term follow-up
Participants are monitored for long-term outcomes such as implant survival and persistent post-surgical pain
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?
2
Treatment groups
Experimental Treatment
Active Control
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
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
Hamilton Academic Health Sciences Organization
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Published Research Related to This Trial
Citations
Robotic-assisted unicompartmental knee arthroplasty ...
This meta-analysis showed that the robotic approach for UKA provided a significant improvement in functional outcomes compared to the conventional manual ...
Robot-assisted partial knee replacement versus standard total ...
Secondary (clinical) outcomes include joint awareness, return to activities, knee function, patient global impression of change, persistent post ...
Robot-assisted total vs. unicompartmental knee arthroplasty
This systematic review and meta-analysis aimed to evaluate the effectiveness of RA-total knee arthroplasty (TKA) and unicompartmental knee ...
Early results of robot-assisted knee replacement
20 patients diagnosed with stage 3 osteoarthritis of the knee joint and varus deformity of the knee joint axis were included in a prospective randomized study.
Robotic‐assisted partial knee surgery performances: A 10 ...
The study demonstrates excellent long-term satisfaction rates, improved clinical outcomes and implant survival with minimal surgical morbidity.
Current trends of unicompartmental knee arthroplasty (UKA ...
Robotic-assisted surgery was associated with a prolonged surgical time of 16.4 min in uUKA and 29.1 min in biUKA compared to conventional ...
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