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Knee OsteoarthritisRoboKneesNCT04378049

Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement

A study testing Total knee arthroplasty and Robot-assisted partial knee arthroplasty in people with Knee Osteoarthritis, run by McMaster University at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Total knee arthroplasty and Robot-assisted partial knee arthroplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteCanada
Study dates
23 Nov 2020to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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 locations and contacts

1 site in 1 country.

Canada1 site
  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement: A Pilot Randomized Controlled Trial

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.

Read the detailed 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.

Being tested
Total knee arthroplasty, Robot-assisted partial knee arthroplasty
Keywords
Total knee arthroplasty, Unicompartmental knee arthroplasty, Robot-assisted surgery, Pilot randomized controlled trial, Bicompartmental knee arthroplasty, Mako partial knee
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total knee arthroplastyProcedure or surgery

    Also called Total knee replacement

    Surgeon will perform a total knee arthroplasty procedure according to local standard of care

  • Robot-assisted partial knee arthroplastyProcedure or surgery

    Also called MakoPlasty

    Surgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure

Study groups in NCT04378049
Study groupRoleWhat they receive
Standard total knee arthroplastyActive comparatorParticipants 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.
Receives: Procedure: Total knee arthroplasty
Robot-assisted partial knee arthroplastyExperimentalParticipants 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
Receives: Procedure: Robot-assisted partial knee arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility- Recruitment

    The number of patients recruited during a 12 month period

    Measured: 12 months

  2. Feasibility- Participant retention

    Number of patients completing the study

    Measured: 12 months

  3. Feasibility- Treatment compliance

    The number of crossovers during a 12 month period

    Measured: 12 months

Secondary outcomes (12)
  1. Return to function questionnaire

    We will use the 5-item Return To Function (RTF) questionnaire to determine when a trial participant returns to work, leisure, and activities around the home after an injury or surgery (measured as time to return to unrestricted activities).

    Measured: 12 months post-surgery

  2. Oxford knee score

    We will measure knee function using the Oxford Knee Score (OKS), which is a validated and well-used 12 item questionnaire used to measure knee function when performing daily activities after total knee replacement surgery. The OKS is scored on a 0-48 scale with higher scores representing a better outcome.

    Measured: 12 months post-surgery

  3. Forgotten joint score

    We will use the Forgotten Joint Score (FJS-Knee) to measure how natural the replaced knee feels. The FJS-Knee is a 12 item questionnaire that aims to assess both function and feeling by asking about patients' awareness of their artificial knee while doing various daily activities. The FJS is scored on a 0-100 scale with higher scores representing a better outcome.

    Measured: 12 months post-surgery

  4. Gait walking mechanics analysis

    Overground walking kinematic gait analysis will be performed in the clinic environment using a ten-camera optoelectronic motion capture system. Primary gait outcomes will include the knee joint flexion and adduction angle magnitudes and range during the stance phase of gait. Secondary gait outcomes will include stride characteristics as defined above, knee transverse rotation during stance, knee flexion during swing, hip and ankle range of motion and peak magnitudes during stance.

    Measured: 12 months post-surgery

  5. Quality of life- EQ-5D

    We will use the Euro-Qol 5 Dimensions (EQ-5D) questionnaire, a widely used and well-validated quality of life tool, to measure participant quality of life. The EQ-5D is a comprehensive, 5-item compact health status classification and health state preference questionnaire.

    Measured: 12 months post-surgery

  6. Persistent post-surgical pain (PPSP)

    We will use a modified version of the WHO's definition of PPSP, to include a minimum threshold of pain severity:

    1. Pain that began after surgery or a tissue trauma;
    2. Pain is in an area of preceding surgery or tissue trauma;
    3. Pain has persisted for at least three months after surgery; and
    4. The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause.
    5. ≥4 out of 10 on the numeric rating scale (NRS) from the Brief Pain Inventory (BPI-SF) for "average pain over the last week". The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine)

    Measured: 12 months post-surgery

  7. Patient global impression of change score

    We will use The Patient Global Impression of Change (PGIC) scale to assess patients' beliefs about the efficacy of treatment. The PGIC is one item and asks patients to rate the effectiveness of the treatment of interest on a 7-point ordinal scale ranging from "very much improved" to "very much worse

    Measured: 12 months post-surgery

  8. Healthcare resource use (for cost-effectiveness)

    We will collect healthcare resource utilization information (e.g. hospitalization, physician visits) and information on productivity (e.g. time missed from work) to assist with health economic analyses.

    Measured: 12 months post-surgery

  9. Rage of motion (ROM)

    We will measure knee ROM using a goniometer at in-clinic visits according to standard practice

    Measured: 6 weeks post-surgery

  10. Knee alignment

    We will measure mechanical alignment on pre-operative and post-operative weightbearing x-rays

    Measured: Post-surgery

  11. Adverse events

    We will collect all serious adverse events and surgery-related non-serious adverse events throughout the trial for safety monitoring purposes

    Measured: 12 months post-surgery

  12. Short-term implant survival

    We will report the number of revision surgeries within the study period including cases of periprosthetic joint infection, aseptic loosening, instability, poly wear, intractable pain, periprosthetic fracture etc.

    Measured: 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start23 Nov 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378049
Sponsor's protocol ID
RoboKnees
Acronym
RoboKnees
Status last verified
May 2025
First submitted
4 May 2020
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share data upon reasonable request for non-commercial purposes. This may require an institutional data-sharing agreement.

Publications

  • Madden K, Flood B, Malek M, Milantoni V, Astephen Wilson JL, Tarride JE, Khanna V, Adili A; RoboKnees Investigators. Robot-assisted partial knee replacement versus standard total knee replacement (RoboKnees): a protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Feb 21;10(1):39. doi: 10.1186/s40814-024-01463-x.

    PubMed 38383530

Questions about this trial

What is this clinical trial studying?

A study testing Total knee arthroplasty and Robot-assisted partial knee arthroplasty in people with Knee Osteoarthritis, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility- Recruitment (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04378049, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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