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

Study acronym: VELYS RCT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion moved earlier from Dec 30, 2030 to Oct 14, 2027
    • Eligibility criteria shortened, about 1 word
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07533188
Lead Sponsor Singapore General Hospital
Conditions
(from sponsor)		 Knee Osteoarthritis, Degenerative Joint Disease of the Knee
Related terms Osteoarthritis, Knee
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov