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Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types

Key facts

Who runs it
Singapore General Hospital
Where
Singapore1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
240 people, planned
Started
14 Oct 2025
Expected to end
14 Oct 2027
Type of study
Interventional, 4 groups
Treatments tested
  • Medial Stabilized Insert
  • Cruciate Retaining Insert
Record updated
21 April 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Other 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Kinematic Alignment + Medial Stabilized InsertTreatment being tested

    Patients undergoing kinematic alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.

    Treatment: Medial Stabilized Insert

  • Kinematic Alignment + Cruciate Retaining InsertTreatment being tested

    Patients undergoing kinematic alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty

    Treatment: Cruciate Retaining Insert

  • Functional Alignment + Medial Stabilized InsertTreatment being tested

    Patients undergoing functional alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.

    Treatment: Medial Stabilized Insert

  • Functional Alignment + Cruciate Retaining InsertTreatment being tested

    Patients undergoing functional alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty

    Treatment: Cruciate Retaining Insert

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
21 April 2026