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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

Must not have

Previous major knee surgery or trauma

Revision knee surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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

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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:

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I have had major knee surgery or experienced significant knee trauma.

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I am scheduled for or have had a knee surgery revision.

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I am having surgery on both knees at the same time.

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I do not want to join the clinical trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met