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.
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.
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.
- Conditions
- Knee Osteoarthritis
- 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 group | Role | What they receive |
|---|---|---|
| Standard total knee arthroplasty | Active comparator | 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. Receives: Procedure: Total knee arthroplasty |
| Robot-assisted partial knee arthroplasty | Experimental | 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 Receives: Procedure: Robot-assisted partial knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Recruitment
The number of patients recruited during a 12 month period
Measured: 12 months
Feasibility- Participant retention
Number of patients completing the study
Measured: 12 months
Feasibility- Treatment compliance
The number of crossovers during a 12 month period
Measured: 12 months
Secondary outcomes (12)
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
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
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
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
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
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:
- Pain that began after surgery or a tissue trauma;
- Pain is in an area of preceding surgery or tissue trauma;
- Pain has persisted for at least three months after surgery; and
- The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause.
- ≥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
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
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
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
Knee alignment
We will measure mechanical alignment on pre-operative and post-operative weightbearing x-rays
Measured: Post-surgery
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
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.
- First posted7 May 2020
- Study start23 Nov 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Hamilton Academic Health Sciences Organization, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Anthony Adili, MD, P.Eng, FRCSC, Principal investigator, McMaster University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04378049
- Acronym / sponsor ID
- RoboKnees / RoboKnees
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, Unicompartmental knee arthroplasty, Robot-assisted surgery, Pilot randomized controlled trial, Bicompartmental knee arthroplasty, Mako partial knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Hamilton Academic Health Sciences Organization, Canadian Institutes of Health Research (CIHR)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard total knee arthroplasty | Active comparator | Procedure: Total knee arthroplastyParticipants 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. |
| Robot-assisted partial knee arthroplasty | Experimental | Procedure: Robot-assisted partial knee arthroplastyParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyAlso: Total knee replacementSurgeon will perform a total knee arthroplasty procedure according to local standard of care | Procedure or surgery | Standard total knee arthroplasty |
| Robot-assisted partial knee arthroplastyAlso: MakoPlastySurgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure | Procedure or surgery | Robot-assisted partial knee arthroplasty |
Primary outcome
Feasibility- Recruitment
Time frame: 12 months
The number of patients recruited during a 12 month period
Feasibility- Participant retention
Time frame: 12 months
Number of patients completing the study
Feasibility- Treatment compliance
Time frame: 12 months
The number of crossovers during a 12 month period
12 secondary outcomes
Return to function questionnaire
Time frame: 12 months post-surgery
Oxford knee score
Time frame: 12 months post-surgery
Forgotten joint score
Time frame: 12 months post-surgery
Gait walking mechanics analysis
Time frame: 12 months post-surgery
Quality of life- EQ-5D
Time frame: 12 months post-surgery
Persistent post-surgical pain (PPSP)
Time frame: 12 months post-surgery
Patient global impression of change score
Time frame: 12 months post-surgery
Healthcare resource use (for cost-effectiveness)
Time frame: 12 months post-surgery
Rage of motion (ROM)
Time frame: 6 weeks post-surgery
Knee alignment
Time frame: Post-surgery
Adverse events
Time frame: 12 months post-surgery
Short-term implant survival
Time frame: 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Derived from this study: PubMed 38383530Madden 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.
- Individual participant dataSharing planned: Yes. We will share data upon reasonable request for non-commercial purposes. This may require an institutional data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Adili, MD, P.Eng, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
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.