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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGolden Jubilee National Hospital

About this trial

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 criteria

Qualifiers

Aged >18 years

Primary knee OA

Requiring TKA

Suitable for either raTKA or mTKA

Disqualifiers

Inflammatory arthritis

Significant symptomatic hip, ankle, or contralateral knee OA

Prior TKA or major injury or major surgery on the index knee

Neuromuscular gait disorders

Trial design

Treatments tested in this trial

  • Robot-Assisted Functionally Aligned Total Knee Replacement
  • Manual Total Knee Arthroplasty

Treatment groups

346 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Golden Jubilee National Hospital

Lead sponsor

Johnson & Johnson

Collaborator

DePuy Orthopaedics

Collaborator