Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement
Key facts
- Who runs it
- McMaster University
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 64 people, planned
- Started
- 23 Nov 2020
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Total knee arthroplasty
- Robot-assisted partial knee arthroplasty
- Record updated
- 9 May 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Revision knee surgery
- Simultaneous bilateral knee surgery
- Previous major knee surgery or trauma
- A CT scan cannot be obtained prior to surgery
- Inability to provide informed consent (e.g. cognitive disability, language barrier)
- The robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock)
- Patient does not wish to participate
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Standard total knee arthroplastyExisting treatment, for comparison
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: Total knee arthroplasty
- Robot-assisted partial knee arthroplastyTreatment being tested
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
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement: A Pilot Randomized Controlled Trial
- Record updated
- 9 May 2025