Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment240 (estimated)
SponsorSingapore General Hospital
Academic / other
Locations1 site (Singapore)
StatusRecruiting
StartedOctober 14, 2025
Main results expectedOctober 14, 2027
Study endsOctober 14, 2027
Registry record updatedApril 21, 2026
Trial IDNCT07533188 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

  • Singapore General Hospital
    Singapore, Singapore
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.