Manual Arthroplasty Versus VELYS Robot-assisted Functional Alignment in Total Knee Arthroplasty
ClinicalTrials.gov Studies
Summary
This ClinicalTrials.gov registry entry documents NCT07551856, a randomized clinical trial comparing VELYS Robotic-Assisted Solution (VRAS) device-assisted total knee replacement against conventional manual total knee arthroplasty in patients with knee osteoarthritis. The trial aims to evaluate patient-reported outcomes (function, satisfaction, pain), clinical outcomes (revision risk, complications, length of stay), biomechanical motion analysis, and cost-efficiency. No compliance obligations or regulatory deadlines are imposed by this registry entry.
“The goal of this clinical trial is to learn if the VELYS Robotic-Assisted Solution (VRAS) device helps to improve outcomes from total knee replacement, when compared to regular non-robotic-assisted total knee replacement in the treatment of osteoarthritis.”
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What changed
This registry entry documents a new randomized clinical trial (NCT07551856) registered on ClinicalTrials.gov comparing robotic-assisted (VELYS) to manual total knee arthroplasty. The trial will enroll participants with knee osteoarthritis, randomizing them to either the VRAS device-assisted procedure or standard manual replacement, and will measure outcomes including function, satisfaction, pain, revision risk, complications, hospital length of stay, biomechanics, and cost-efficiency.
Healthcare providers, clinical investigators, and medical device manufacturers should note this trial as it may generate clinical evidence relevant to the VRAS device's safety and efficacy profile once results are published. The trial represents standard randomized controlled trial methodology for evaluating surgical device outcomes and does not impose any immediate compliance requirements on regulated entities.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Manual Arthroplasty Versus VELYS Robot-assisted Functional Alignment in Total Knee Arthroplasty
N/A NCT07551856 Kind: NA Apr 27, 2026
Abstract
The goal of this clinical trial is to learn if the VELYS Robotic-Assisted Solution (VRAS) device helps to improve outcomes from total knee replacement, when compared to regular non-robotic-assisted total knee replacement in the treatment of osteoarthritis. It will also aim to review the longer-term safety and efficiency effects of using this device.
The main questions it aims to answer are:
- Does VRAS device-assisted total knee replacement improve patient outcomes (such as their function, satisfaction, and pain) when compared to non-robotic-assisted total knee replacement?
- Does VRAS device-assisted total knee replacement improve clinical outcomes (such as revision risk, complications, and hospital length of stay) when compared to non-robotic-assisted total knee replacement?
- Does VRAS device-assisted total knee replacement improve functional outcomes (including biomechanical motion analysis) when compared to non-robotic-assisted total knee replacement?
- What are the economic and efficiency effects of VRAS device-assisted total knee replacement compared to non-robotic-assisted total knee replacement?
- What are the human factor and learning curve effects of introducing VRAS device-assisted total knee replacement into healthcare teams?
- Are there any differences in safety and adverse event incidence between VRAS device-assisted total knee replacement and non-robotic-assisted total knee replacement?
Participants will:
- Be randomised to receive a total knee re...
Conditions: Knee Osteoarthritis, Osteoarthritis (Knee), Osteo Arthritis of the Knee, Osteo Arthritis, Osteoarthritis (OA), Osteoarthritis, Osteoarthritis in the Knee
Interventions: Robot-Assisted Functionally Aligned Total Knee Replacement, Manual Total Knee Arthroplasty
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