Robot-Assisted vs Standard Knee Replacement for Osteoarthritis

(RoboKnees Trial)

Overseen By Kim Madden, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Cognitive disability, Language barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

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.

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?

Group I: Robot-assisted partial knee arthroplasty Experimental Treatment 1 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 arthroplasty Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11061807/

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10880336/

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 ...

3. turkjsurg.com turkjsurg.com/articles/robot-assisted-total-vs-unicompartmental-knee-arthroplasty-a-systematic-review-and-meta-analysis/turkjsurg.2025.2025-5-14

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X24000572

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.

5. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/ksa.12599

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.

6. arthroplasty.biomedcentral.com arthroplasty.biomedcentral.com/articles/10.1186/s42836-024-00289-5

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 ...