Total Knee Arthroplasty (TKA)NCT06563843
VRAS (Velys Robot-Assisted Solution) Operational Excellence Study
An observational study of Total Knee Arthroplasty (TKA), run by DEO NV at 10 sites in 8 countries.
Trial summary
The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty (TKA)
- What is being tested?
- Robotic-assisted TKA and Conventional TKA
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 10 sitesin 8 countries
- Study dates
- 30 Jan 2025to Mar 2027
- Phase
- Observational
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The 10 participants of the study are orthopaedic surgeons. They will execute at least 5 conventional TKA procedures and at least 5 VELYS robot-assisted TKA procedures. This study is observational, with a focus on operational excellence, and as such DEO.care will not influence surgeon's decisions with regards to surgical technique philosophies. Surgeon will select the relevant techniques for each case at his/her own discretion.
Who may be able to join
- Orthopaedic surgeons performing conventional and robot-assisted TKA
Who cannot join
- /
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Austria2 sites
Herz-Jesu Krankenhaus
Vienna
Orthopädisches Spital Speising
Vienna
United Kingdom2 sites
Leeds Teaching Hospitals NHS Trust
Leeds
Liverpool University Hospitals NHS Foundation Trust - Broadgreen Hospital
Liverpool
About this study
Official title: Comparison Between Velys Robotic-Assisted Solution (VRAS) and Conventional Surgery in Total Knee Arthroplasty: An Operational Excellence Evaluation
The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.
Read the detailed description
The increasing number of total knee arthroplasty (TKA) procedures is putting a significant burden on healthcare systems, surgeons and their surgical teams. Technology is introduced to improve accuracy, reproducibility and efficiency of TKA surgery, and a significant portion of the patient population is now being treated using Robotic Assisted Surgery. However, robotic surgeries are believed to have a longer procedure time.
The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.
In this multicentre study, measurements will be conducted in 10 hospitals with 10 selected surgeons across selected countries in Europe and the UK. For each surgeon enrolled, a minimum of five VRAS assisted surgical procedures and five conventional surgical procedures will be observed. The OR set-up will be similar for all cases in the same hospital. The same experienced surgeon will conduct all procedures.
- Conditions
- Total Knee Arthroplasty (TKA)
- Being tested
- Robotic-assisted TKA, Conventional TKA
- Keywords
- VELYS, Total Knee Arthroplasty (TKA), Process flow, Robotic-assisted surgery, Operational excellence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted TKAProcedure or surgery
Also called DePuy Synthes, Velys Robotic-Assisted Solution
Robotic-assisted Total Knee Arthroplasty or total knee replacement is a surgical procedure using a robot to resurface a knee joint damaged with arthritis, and where the knee joint of the patient is replaced with a prosthesis.
Conventional TKAProcedure or surgery
Also called DePuy Synthes, Attune Knee System, Sigma Total Knee System
Conventional Total Knee Arthroplasty or total knee replacement is a surgical procedure to manually resurface a knee joint damaged with arthritis, and where the knee joint of the patient is replaced with a prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Performing VELYS robot-assisted TKA | Surgeons performing VELYS robot-assisted TKA Receives: Procedure: Robotic-assisted TKA | |
| Performing conventional TKA | Surgeons performing conventional TKA Receives: Procedure: Conventional TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operational efficiency
Efficiency will be assessed using OR time, by comparing the OR days and procedures where TKR is performed conventionally or by using VRAS surgery.
A granular analysis from the timestamps will be conducted using standard descriptive statistics. Additionally, the impaction process will be further analyzed, broken down into parts.
Measured: 3 months
Secondary outcomes (3)
Ergonomic impaction - weight of trays
Weight of trays will be measured to report ergonomic impaction of the team for the VRAS TKR compared to conventional TKR.
Measured: 3 months
Ergonomic impaction - posture assessment
Surgeon's posture assessment using RULA and REBA method will be executed to report ergonomic impaction for the VRAS TKR compared to conventional TKR.
Measured: 3 months
Total procedure cost
The procedure cost differences between VRAS TKR and conventional TKR will be calculated using activity based costing modeling. This model will include fixed direct, fixed indirect, and variable costs, tailored to each country's local cost parameters and healthcare financing models.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start30 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (TKA)Studies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DEO NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Willem Franssen, Msc., Study director, DEOcarePieter-Jan Vandekerckhove, M.D., Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563843
- Sponsor's protocol ID
- VRAS
- Other IDs
- 363482
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Velys Robotic-Assisted Solution (VRAS) and Conventional Surgery in Total Knee Arthroplasty: An Operational Excellence Evaluation
- ClinicalTrials.gov ID
- NCT06563843
- Acronym / sponsor ID
- VRAS
- Conditions
- Total Knee Arthroplasty (TKA)
- Keywords
- VELYS, Total Knee Arthroplasty (TKA), Process flow, Robotic-assisted surgery, Operational excellence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- DEO NVIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Aug 2024 (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.
The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.
Detailed description
The increasing number of total knee arthroplasty (TKA) procedures is putting a significant burden on healthcare systems, surgeons and their surgical teams. Technology is introduced to improve accuracy, reproducibility and efficiency of TKA surgery, and a significant portion of the patient population is now being treated using Robotic Assisted Surgery. However, robotic surgeries are believed to have a longer procedure time.
The aim of this study is to investigate the differences in process set-up, efficiency, OR team workload, instrument trays and OR financial performance when using the VRAS (Velys Robotic Assisted Solution) of DePuy Synthes compared to conventional TKA.
In this multicentre study, measurements will be conducted in 10 hospitals with 10 selected surgeons across selected countries in Europe and the UK. For each surgeon enrolled, a minimum of five VRAS assisted surgical procedures and five conventional surgical procedures will be observed. The OR set-up will be similar for all cases in the same hospital. The same experienced surgeon will conduct all procedures.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performing VELYS robot-assisted TKA | – | Procedure: Robotic-assisted TKASurgeons performing VELYS robot-assisted TKA |
| Performing conventional TKA | – | Procedure: Conventional TKASurgeons performing conventional TKA |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The 10 participants of the study are orthopaedic surgeons. They will execute at least 5 conventional TKA procedures and at least 5 VELYS robot-assisted TKA procedures. This study is observational, with a focus on operational excellence, and as such DEO.care will not influence surgeon's decisions with regards to surgical technique philosophies. Surgeon will select the relevant techniques for each case at his/her own discretion.
Key inclusion criteria (1 listed)
- Orthopaedic surgeons performing conventional and robot-assisted TKA
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| Robotic-assisted TKAAlso: DePuy Synthes, Velys Robotic-Assisted SolutionRobotic-assisted Total Knee Arthroplasty or total knee replacement is a surgical procedure using a robot to resurface a knee joint damaged with arthritis, and where the knee joint of the patient is replaced with a prosthesis. | Procedure or surgery | Performing VELYS robot-assisted TKA |
| Conventional TKAAlso: DePuy Synthes, Attune Knee System, Sigma Total Knee SystemConventional Total Knee Arthroplasty or total knee replacement is a surgical procedure to manually resurface a knee joint damaged with arthritis, and where the knee joint of the patient is replaced with a prosthesis. | Procedure or surgery | Performing conventional TKA |
Primary outcome
Operational efficiency
Time frame: 3 months
Efficiency will be assessed using OR time, by comparing the OR days and procedures where TKR is performed conventionally or by using VRAS surgery. A granular analysis from the timestamps will be conducted using standard descriptive statistics. Additionally, the impaction process will be further analyzed, broken down into parts.
3 secondary outcomes
Ergonomic impaction - weight of trays
Time frame: 3 months
Ergonomic impaction - posture assessment
Time frame: 3 months
Total procedure cost
Time frame: 3 months
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 23 Oct 2026.
- 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. This study is not recruiting at the moment.
Willem Franssen, Msc. study director
DEOcare
Pieter-Jan Vandekerckhove, M.D. principal investigator
AZ Sint-Jan AV
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty (TKA), run by DEO NV at 10 sites in 8 countries.
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 1 inclusion and 1 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Austria, United Kingdom, Belgium, France, Germany and 3 more countries. 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?
Operational efficiency (time frame: 3 months). 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 23 Oct 2026.