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).
Aged >18 years
Primary knee OA
Requiring TKA
Suitable for either raTKA or mTKA
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
Parallel
Robot-Assisted Functionally Aligned Total Knee Replacement
DeviceThis 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/SurgeryThis 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.
Change in Forgotten Joint Score
Using validated Forgotten Joint Score questionnaire. Maximum score 100, minimum 0. Higher score equates to better outcome.
Change in Forgotten Joint Score
Using validated Forgotten Joint Score questionnaire. Maximum score 100, minimum 0. Higher score equates to better outcome.
Absolute Forgotten Joint Score
Using validated Forgotten Joint Score questionnaire. Maximum score 100, minimum 0. Higher score equates to better outcome.
Oxford Knee Score
Using validated Oxford Knee Score questionnaire. Maximum is 48, minimum is 0. Higher score equates to better outcome.
EQ-5D-5L
Using validated EQ-5D-5L quality of life questionnaire. For the description component a subject self-rates their health in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five-level scale. The evaluation component requires a patient to record their overall health status using a visual analogue scale. Following assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health). With the overall health status from the evaluation component reported as a number from 0 (worst overall health state) to 100 (best overall health state).
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Golden Jubilee National Hospital
Lead sponsor
Johnson & Johnson
Collaborator
DePuy Orthopaedics
Collaborator
