Outcomes after robotic-assisted total knee replacement using kinematic or functional alignment with randomized implant inserts
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
Run by Singapore General Hospital · NCT07533188 · Data updated 2026-11-12
This project will test whether two types of knee implant inserts (medial-stabilized versus cruciate-retaining) affect recovery for people having robotic-assisted total knee replacement with either kinematic or functional alignment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Status | Recruiting |
| Started | October 14, 2025 |
| Main results expected | October 14, 2027 |
| Study ends | October 14, 2027 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07533188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with knee osteoarthritis scheduled for primary robotic-assisted total knee arthroplasty using the VELYS system who can give informed consent and complete follow-up outcome measures are ideal candidates.
✕Probably not a fit
Patients undergoing revision knee arthroplasty, those with active infection, severe comorbidities that impact recovery, or those unable to comply with follow-up are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective interventional study enrolls patients undergoing robotic-assisted total knee arthroplasty using the VELYS system. The operating surgeon chooses either kinematic or functional alignment as part of routine care, and within each alignment group participants are randomly assigned to receive a medial-stabilized or a cruciate-retaining insert via a REDCap allocation system. Patient-reported outcome measures are collected before surgery and at scheduled follow-up visits, with secondary clinical and functional measures recorded as predefined outcomes. The design combines real-world surgical practice with a randomized implant comparison to inform implant-related outcomes across alignment techniques.
Why it matters
Potential benefit: If successful, the results could help identify which insert type leads to better pain relief, function, and patient satisfaction after robotic-assisted knee replacement.
How similar studies have gone: Robotic-assisted knee replacement and different alignment strategies have shown promising functional results in prior studies, but randomized comparisons specifically between medial-stabilized and cruciate-retaining inserts are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
\*Inclusion Criteria:\* * 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 \*\*Exclusion Criteria:\*\* * 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
Where it's running
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Singapore General Hospital
Singapore, Singapore Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.