Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement (RoboKnees)

McMaster University

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Procedure: Robot-assisted partial knee arthroplasty; Procedure: Total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04378049

RoboKnees

Details and patient eligibility

About

This is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.

Full description

Knee osteoarthritis (OA) pain is an important source of morbidity and cost to the health care system. Over 60,000 knee replacement surgeries are performed in Canada every year, making it the second most common surgery. Our institution (St. Joseph's Healthcare Hamilton) is the first hospital in Canada to purchase a Mako RIO orthopaedic robot to assist with performing knee replacements. The knee is divided into three compartments, and one, two, or all three compartments can become arthritic. Over 90% of patients with end-stage knee OA receive a total knee replacement (also known as total knee arthroplasty or TKA) even if they have one or two healthy knee compartments. Partial knee replacements are an option for these patients but these procedures are very technically demanding and associated with a higher risk of implant failure. For this reason, few surgeons are experts at partial knee replacements. We believe that we can use robotic technology to make it easier for surgeons to perform partial replacements more accurately, thereby increasing the quality and survivorship of partial knee replacements. This may lead to better patient-important outcomes like return to activity, pain, and satisfaction, and eventually better access to high-quality partial knee replacements for Canadians. This will be the first study to evaluate total knee replacements (standard care) versus robot-assisted partial knee replacements, and could lead to greater uptake of robotic technology in orthopaedics and a shift toward anatomy-sparing partial knee replacements.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Adult (18+)
• Unicompartmental knee OA with or without concomitant patellofemoral OA, requiring surgical treatment
• Two study surgeons independently agree that the patient is eligible for either treatment group

Exclusion criteria

• Inability to provide informed consent (e.g. cognitive disability, language barrier)
• Revision knee surgery
• Simultaneous bilateral knee surgery
• Previous major knee surgery or trauma
• The robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock)
• A CT scan cannot be obtained prior to surgery
• Patient does not wish to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Standard total knee arthroplasty

Active Comparator group

Description:

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.

Treatment:

Procedure: Total knee arthroplasty

Robot-assisted partial knee arthroplasty

Experimental group

Description:

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

Treatment:

Procedure: Robot-assisted partial knee arthroplasty