Knee OsteoarthritisRobARNCT06891807
Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty
A study testing Robotics Assisted TKA and Augmented Reality assisted TKA in people with Knee Osteoarthritis and Total Knee Arthroplasty\(TKA\), run by Medisch Centrum Latem at 1 site in Belgium.
Trial summary
This study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. Both surgical techniques are already commonly used. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty\(TKA\), Total Knee Replacement Surgery
- What is being tested?
- Robotics Assisted TKA and Augmented Reality assisted TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jul 2024to 1 Oct 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects from 18 years up to 85 years old
- Patients eligible and planned for a primary Total Knee Arthroplasty
- Patients willing to sign the informed consent form (ICF) for participating in this study
- Indication of surgery is primary osteoarthritis
Who cannot join
- Revision knee surgery
- Other medical conditions contributing to the rehabilitation process of the TKA according to the surgeon, such as Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident
- The patient received a TKA within the last three months or has a TKA planned in the next three months, for the contralateral knee
- Patient is participating in another clinical trial
- Patient is not able to understand Dutch, French or English
- Patients who did not meet all of the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Medisch Centrum Latem
Sint-Martens-Latem, Oost-Vlaanderen, 9830
Philippe Van Overschelde, MD, MSc, MBA, +32 9 220 88 68, secretariaat.heupknie@azmmsj.be
Cynthia Lapierre, MSc, +32 9 220 88 68, cynthia.lapierre@mijnziekenhuis.be
About this study
Official title: RobAR Study: Comparison of Image Based Robotic TKA vs Imageless Augmented Reality-Assisted TKA
This study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. Both surgical techniques are already commonly used. During both the robotic technique and the augmented reality technique, the additional information (angles - axes) obtained during the operation is used to optimize the placement of the various prosthesis components.
Patients that were recently diagnosed with advanced osteoarthritis of the knee can participate in this study. This means that the cartilage of the knee is affected by wear and tear. This causes pain, stiffness and swelling resulting in reduced mobility. When non-operative treatments are insufficient in treating the osteoarthritis, surgery is proposed wherein a knee arthroplasty is performed.
The goal of this study is to further optimize and personalize patient care. Additionally, the aim of the study is to investigate whether both techniques are equivalent in optimally placing the prosthesis and whether both techniques lead to comparable results.
- Being tested
- Robotics Assisted TKA, Augmented Reality assisted TKA
- Keywords
- Total Knee Arthroplasty (TKA), Knee Osteoarthritis, Assistive Technologies, Robotics, Augmented Reality
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotics Assisted TKADevice
Also called Skywalker Robotics Assisted TKA
Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee
Augmented Reality assisted TKADevice
Also called Pixee Knee+ TKA
Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee
| Study group | Role | What they receive |
|---|---|---|
| Skywalker | Active comparator | SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee Receives: Device: Robotics Assisted TKA |
| Pixee Knee+ | Active comparator | PIXEE Knee+ TKA using Evolution Medial Pivot Knee Receives: Device: Augmented Reality assisted TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic alignment and positioning of the implant on full-leg standing X-Rays
To evaluate the radiographic alignment and positioning of the implant on full-leg standing X-Rays at a minimum of 1 year follow up between two TKA assistive technologies. These results will be compared with the intraoperative settings for alignment and positioning of the implant.
Measured: 1 year follow-up
Secondary outcomes (2)
Safety and clinical outcomes of assistive TKA technologies
Percentage change from baseline in activity parameters measured by a wearable device and clinical status measured by patient reported outcome measurements (PROM) at 6 weeks, 3 months, 6 months, 1 year and 2 years after TKA surgery. Safety will be assessed based on the incidence of treatment-related complications (e.g., wound complications, infection, nerve injury, peri-prosthetic fracture, urinary tract infection, deep vein thrombosis and pulmonary embolism ) as reported by patients and documented in medical records.
Measured: 2 year follow-up
Activity parameters
Percentage change from baseline in activity parameters (e.g., step count, activity types, amount of activities) measured by a wearable device, daily questionnaires and measured by the UCLA activity score at 6 weeks, 3 months, 6 months, 1 year and 2 years after TKA surgery.
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start18 Jul 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Centrum Latem
- Sponsor type
- University, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Responsible party
- Principal investigator, Philippe Van Overschelde, Medisch Centrum Latem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891807
- Sponsor's protocol ID
- MMS.2024.021
- Other IDs
- B0172024000001
- Acronym
- RobAR
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RobAR Study: Comparison of Image Based Robotic TKA vs Imageless Augmented Reality-Assisted TKA
- ClinicalTrials.gov ID
- NCT06891807
- Acronym / sponsor ID
- RobAR / MMS.2024.021
- Keywords
- Total Knee Arthroplasty (TKA), Knee Osteoarthritis, Assistive Technologies, Robotics, Augmented Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medisch Centrum LatemUniversity, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 24 Mar 2025 (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 study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. Both surgical techniques are already commonly used. During both the robotic technique and the augmented reality technique, the additional information (angles - axes) obtained during the operation is used to optimize the placement of the various prosthesis components.
Patients that were recently diagnosed with advanced osteoarthritis of the knee can participate in this study. This means that the cartilage of the knee is affected by wear and tear. This causes pain, stiffness and swelling resulting in reduced mobility. When non-operative treatments are insufficient in treating the osteoarthritis, surgery is proposed wherein a knee arthroplasty is performed.
The goal of this study is to further optimize and personalize patient care. Additionally, the aim of the study is to investigate whether both techniques are equivalent in optimally placing the prosthesis and whether both techniques lead to comparable results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skywalker | Active comparator | Device: Robotics Assisted TKASkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee |
| Pixee Knee+ | Active comparator | Device: Augmented Reality assisted TKAPIXEE Knee+ TKA using Evolution Medial Pivot Knee |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects from 18 years up to 85 years old
- Patients eligible and planned for a primary Total Knee Arthroplasty
- Patients willing to sign the informed consent form (ICF) for participating in this study
- Indication of surgery is primary osteoarthritis
Key exclusion criteria (6 listed)
- Revision knee surgery
- Other medical conditions contributing to the rehabilitation process of the TKA according to the surgeon, such as Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident
- The patient received a TKA within the last three months or has a TKA planned in the next three months, for the contralateral knee
- Patient is participating in another clinical trial
- Patient is not able to understand Dutch, French or English
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 |
|---|---|---|
| Robotics Assisted TKAAlso: Skywalker Robotics Assisted TKASkywalker Robotics Assisted TKA using Evolution Medial Pivot Knee | Device | Skywalker |
| Augmented Reality assisted TKAAlso: Pixee Knee+ TKAPixee Knee+ assisted TKA using Evolution Medial Pivot Knee | Device | Pixee Knee+ |
Primary outcome
radiographic alignment and positioning of the implant on full-leg standing X-Rays
Time frame: 1 year follow-up
To evaluate the radiographic alignment and positioning of the implant on full-leg standing X-Rays at a minimum of 1 year follow up between two TKA assistive technologies. These results will be compared with the intraoperative settings for alignment and positioning of the implant.
2 secondary outcomes
Safety and clinical outcomes of assistive TKA technologies
Time frame: 2 year follow-up
Activity parameters
Time frame: 2 year follow-up
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 24 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotics Assisted TKA and Augmented Reality assisted TKA in people with Knee Osteoarthritis and Total Knee Arthroplasty\(TKA\), run by Medisch Centrum Latem at 1 site in Belgium.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Mar 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 Belgium. 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?
Contact Philippe Van Overschelde, MD, MSc, MBA (+9 220 88 68, secretariaat.heupknie@azmmsj.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic alignment and positioning of the implant on full-leg standing X-Rays (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2025.