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

Sponsor
Golden Jubilee National Hospital
Study ID
NCT07551856
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Robot-Assisted Functionally Aligned Total Knee Replacement — DEVICE
    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.
  • Manual Total Knee Arthroplasty — PROCEDURE
    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.

Study Details

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).

Key Dates

First listed
Apr 27, 2026
Start date
May 8, 2026
Status verified
Apr 2026
Primary completion
Oct 30, 2029
Completion
May 8, 2030

Study Design

Enrollment
346 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VELYS Robotic-Assisted Total Knee Replacement
    Trial treatment, with an ATTUNE total knee replacement put in by a surgeon using robot-assistance for the bone cuts from the VELYS robot, allowing for functional alignment to be used.
  • Active Comparator: Manual Non-Robotic Total Knee Replacement
    Current standard treatment, with an ATTUNE total knee replacement put in by a surgeon with no robot assistance, using manually-achievable alignment strategies.

Primary Outcome Measure

Change in Forgotten Joint Score [ Time Frame: Pre-surgery to be compared with 6 months post-surgery. ]

Central Contacts

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