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

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).

Conditions

• Knee Osteoarthritis
• Osteoarthritis (Knee)
• Osteo Arthritis of the Knee
• Osteo Arthritis
• Osteoarthritis (OA)
• Osteoarthritis
• Osteoarthritis in the Knee

Interventions

DEVICE

Robot-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.

PROCEDURE

Manual 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.

Sponsors & Collaborators

• Johnson & Johnson

  collaborator INDUSTRY

• DePuy Orthopaedics

  collaborator INDUSTRY

• Golden Jubilee National Hospital

  lead OTHER_GOV

Principal Investigators

• Jon V Clarke, PhD, FRCS (Tr & Orth) · Golden Jubilee University National Hospital

• Nick D Clement, MD, PhD, FRCS (Tr & Orth) · Edinburgh Orthopaedics, Royal Infirmary of Edinburgh

• Andrew J Hall, PhD, MBChB, MRCS (Ed.) · University of St Andrews

• Joanne McGarry · Golden Jubilee University National Hospital

• Christopher Gee, MSc, FRCS (Tr & Orth), MFSTEd · Golden Jubilee University National Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-08

Primary Completion

2029-10-30

Completion

2030-05-08

FDA Device

Yes

Countries

• United Kingdom

Study Locations