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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSingapore General Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Medial Stabilized Insert
  • Cruciate Retaining Insert

Treatment groups

240 Participants
are divided into 4 treatment groups

Sponsors and collaborators