RecruitingNot ApplicableNCT07533188

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

A Prospective Randomized Controlled Trial Comparing Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty Using the VELYS System


Sponsor

Singapore General Hospital

Enrollment

240 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

DEVICEMedial Stabilized Insert

A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.

DEVICECruciate Retaining Insert

A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.


Locations(1)

Singapore General Hospital

Singapore, Singapore

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NCT07533188


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