RecruitingNot ApplicableNCT07551856

Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis

Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis (The MARVEL Project): A Pragmatic, Multicentre, Blinded Randomised Controlled Trial With Multi-domain Investigations


Sponsor

Golden Jubilee National Hospital

Enrollment

346 participants

Start Date

Jul 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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: 1. 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? 2. 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? 3. Does VRAS device-assisted total knee replacement improve functional outcomes (including biomechanical motion analysis) when compared to non-robotic-assisted total knee replacement? 4. What are the economic and efficiency effects of VRAS device-assisted total knee replacement compared to non-robotic-assisted total knee replacement? 5. What are the human factor and learning curve effects of introducing VRAS device-assisted total knee replacement into healthcare teams? 6. 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 replacement using either regular non-robotic-assisted methods, or with the use of the VRAS device. * Be assessed pre-operatively at the clinic, and then at 6 weeks, 6 months, and 12 months following date of operation. At these appointments patients will answer questionnaires, receive an x-ray (pre-operatively, and at 6 months post-operatively), and a subgroup will be reviewed in the motion analysis laboratory (pre-operatively, and at 6 months post-operatively). * Have their longer-term outcomes including any revision operations monitored out to 10 years through national registry data linkage (no actual follow-up for patients after 12 months).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Manual Total Knee Arthroplasty and a medical device called Robot-Assisted Functionally Aligned Total Knee Replacement for people with knee osteoarthritis, osteo arthritis of the knee, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERobot-Assisted Functionally Aligned Total Knee Replacement

This device is a semi-active image-free arthroplasty robot that is under the full control of the surgeon at all times, but helps to make certain parts of the operation more accurate (bone cuts). The device will allow for use of so-called functional alignment. The implant put into the knee (ATTUNE total knee replacement) is the same for either of the techniques used (traditional method or VELYS robot). It has an excellent track record and is widely used in the UK and throughout the world.

PROCEDUREManual Total Knee Arthroplasty

This will be a manual total knee replacement carried out in standard fashion using ATTUNE implants with a good UK and worldwide track record. Alignment philosophies used will be manually achievable.


Locations(1)

Golden Jubilee University National Hospital

Glasgow, Scotland, United Kingdom

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NCT07551856


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