Knee OsteoarthritisVELYS RCTNCT07533188
Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types
A study testing Medial Stabilized Insert and Cruciate Retaining Insert in people with Knee Osteoarthritis and Degenerative Joint Disease of the Knee, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Degenerative Joint Disease of the Knee
- What is being tested?
- Medial Stabilized Insert and Cruciate Retaining Insert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Oct 2025to 14 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing robotic-assisted total knee arthroplasty using the VELYS system
- Diagnosis of knee osteoarthritis requiring surgical intervention
- Able to provide informed consent
- Willing to complete patient-reported outcome measures
Who cannot join
- Patients undergoing revision knee arthroplasty
- Presence of active infection
- Inability to comply with follow-up assessments
- Severe co-morbidities that may affect surgical outcomes or participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore
Clinical Research Coordinator, +6563266400, shameemah.mohamed.fouze@sgh.com.sg
Lincoln Ming Han Liow, MBBS
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty Using the VELYS System
This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.
Read the detailed description
This is a prospective interventional study evaluating outcomes in patients undergoing robotic-assisted total knee arthroplasty using the VELYS system. The study includes patients treated using either kinematic alignment or functional alignment techniques, which are determined by the operating surgeon based on clinical practice and are not randomized as part of the study protocol.
Within each alignment group, participants are randomized to receive one of two implant insert types: medial stabilised (MS) or cruciate retaining (CR). Randomisation is performed using a REDCap-based allocation system.
The primary objective of the study is to assess patient-reported outcomes following surgery. Secondary outcomes may include clinical and functional measures collected at predefined time points, including pre-operative and post-operative follow-up visits.
This study reflects real-world clinical practice while incorporating a randomized component for implant selection. The design allows for evaluation of both implant-related outcomes and comparisons across different alignment techniques, while maintaining clarity regarding which aspects of the intervention are randomized.
- Being tested
- Medial Stabilized Insert, Cruciate Retaining Insert
- Keywords
- Robotic-Assisted Total Knee Arthroplasty, VELYS System, Kinematic Alignment, functional Alignment, Medial Stabilized Insert, Cruciate Retaining Insert, Patient-Reported Outcomes, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Stabilized InsertDevice
Also called MS insert
A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.
Cruciate Retaining InsertDevice
A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.
| Study group | Role | What they receive |
|---|---|---|
| Kinematic Alignment + Medial Stabilized Insert | Experimental | Patients undergoing kinematic alignment with medial stabilised insert in robotic-assisted total knee arthroplasty. Receives: Device: Medial Stabilized Insert |
| Kinematic Alignment + Cruciate Retaining Insert | Experimental | Patients undergoing kinematic alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty Receives: Device: Cruciate Retaining Insert |
| Functional Alignment + Medial Stabilized Insert | Experimental | Patients undergoing functional alignment with medial stabilised insert in robotic-assisted total knee arthroplasty. Receives: Device: Medial Stabilized Insert |
| Functional Alignment + Cruciate Retaining Insert | Experimental | Patients undergoing functional alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty Receives: Device: Cruciate Retaining Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score (FJS)
Forgotten Joint Score (FJS) The Forgotten Joint Score (FJS) is a patient-reported outcome measure assessing joint awareness in daily life following total knee arthroplasty. The score ranges from 0 to 100, with higher scores indicating better outcomes (less joint awareness).
Measured: Pre-operative, 6 weeks, 6 months, and 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start14 Oct 2025
- Primary completion14 Oct 2027 (estimated)
- Study completion14 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.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Model description
- Participants receive either kinematic or functional alignment based on the operating surgeon as part of routine clinical care. Within each alignment group, participants are randomized to receive one of two implant insert types (medial stabilised or cruciate retaining) using a REDCap-based allocation process.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lincoln Liow Ming Han, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533188
- Sponsor's protocol ID
- SGH-VELYS-IMPLANT-RCT-2024
- Other IDs
- 2024-4071
- Acronym
- VELYS RCT
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty Using the VELYS System
- ClinicalTrials.gov ID
- NCT07533188
- Acronym / sponsor ID
- VELYS RCT / SGH-VELYS-IMPLANT-RCT-2024
- Keywords
- Robotic-Assisted Total Knee Arthroplasty, VELYS System, Kinematic Alignment, functional Alignment, Medial Stabilized Insert, Cruciate Retaining Insert, Patient-Reported Outcomes, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2027 (estimated)
- First posted
- 16 Apr 2026 (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 aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.
Detailed description
This is a prospective interventional study evaluating outcomes in patients undergoing robotic-assisted total knee arthroplasty using the VELYS system. The study includes patients treated using either kinematic alignment or functional alignment techniques, which are determined by the operating surgeon based on clinical practice and are not randomized as part of the study protocol.
Within each alignment group, participants are randomized to receive one of two implant insert types: medial stabilised (MS) or cruciate retaining (CR). Randomisation is performed using a REDCap-based allocation system.
The primary objective of the study is to assess patient-reported outcomes following surgery. Secondary outcomes may include clinical and functional measures collected at predefined time points, including pre-operative and post-operative follow-up visits.
This study reflects real-world clinical practice while incorporating a randomized component for implant selection. The design allows for evaluation of both implant-related outcomes and comparisons across different alignment techniques, while maintaining clarity regarding which aspects of the intervention are randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants receive either kinematic or functional alignment based on the operating surgeon as part of routine clinical care. Within each alignment group, participants are randomized to receive one of two implant insert types (medial stabilised or cruciate retaining) using a REDCap-based allocation process.
| Arm | Type | Receives |
|---|---|---|
| Kinematic Alignment + Medial Stabilized Insert | Experimental | Device: Medial Stabilized InsertPatients undergoing kinematic alignment with medial stabilised insert in robotic-assisted total knee arthroplasty. |
| Kinematic Alignment + Cruciate Retaining Insert | Experimental | Device: Cruciate Retaining InsertPatients undergoing kinematic alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty |
| Functional Alignment + Medial Stabilized Insert | Experimental | Device: Medial Stabilized InsertPatients undergoing functional alignment with medial stabilised insert in robotic-assisted total knee arthroplasty. |
| Functional Alignment + Cruciate Retaining Insert | Experimental | Device: Cruciate Retaining InsertPatients undergoing functional alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing robotic-assisted total knee arthroplasty using the VELYS system
- Diagnosis of knee osteoarthritis requiring surgical intervention
- Able to provide informed consent
- Willing to complete patient-reported outcome measures
Key exclusion criteria (4 listed)
- Patients undergoing revision knee arthroplasty
- Presence of active infection
- Inability to comply with follow-up assessments
- Severe co-morbidities that may affect surgical outcomes or participation in the study
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 |
|---|---|---|
| Medial Stabilized InsertAlso: MS insertA medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion. | Device | Functional Alignment + Medial Stabilized Insert, Kinematic Alignment + Medial Stabilized Insert |
| Cruciate Retaining InsertA cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament. | Device | Functional Alignment + Cruciate Retaining Insert, Kinematic Alignment + Cruciate Retaining Insert |
Primary outcome
Forgotten Joint Score (FJS)
Time frame: Pre-operative, 6 weeks, 6 months, and 2 years post-operatively
Forgotten Joint Score (FJS) The Forgotten Joint Score (FJS) is a patient-reported outcome measure assessing joint awareness in daily life following total knee arthroplasty. The score ranges from 0 to 100, with higher scores indicating better outcomes (less joint awareness).
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 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Medial Stabilized Insert and Cruciate Retaining Insert in people with Knee Osteoarthritis and Degenerative Joint Disease of the Knee, run by Singapore General Hospital at 1 site in Singapore.
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 4 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 21 Apr 2026. 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 Singapore. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forgotten Joint Score (FJS) (time frame: Pre-operative, 6 weeks, 6 months, and 2 years post-operatively). 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 21 Apr 2026.