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

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.

NCT Number	NCT07533188
Lead Sponsor	Singapore General Hospital
Conditions	Knee Osteoarthritis, Degenerative Joint Disease of the Knee
Enrollment	240 participants
Start Date	2025-10-14
Primary Completion	2027-10-14 (estimated)
Study Completion	2027-10-14 (estimated)
Updated on ClinicalTrials.gov	2026-04-21