Outcomes after robotic-assisted total knee replacement using kinematic or functional alignment with randomized implant inserts
A Prospective Randomized Controlled Trial Comparing Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty Using the VELYS System
NA · Singapore General Hospital · NCT07533188
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Singapore General Hospital (other) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07533188 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, Degenerative Joint Disease of the Knee, Robotic-Assisted Total Knee Arthroplasty, VELYS System, Kinematic Alignment, functional Alignment, Medial Stabilized Insert, Cruciate Retaining Insert