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
Sponsors and collaborators
Golden Jubilee National Hospital
Lead sponsor
Johnson & Johnson
Collaborator
DePuy Orthopaedics
Collaborator