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

✅ This trial is currently recruiting volunteers

If you think you might be eligible, speak to your GP or specialist about this trial before applying.

Status

Recruiting

Phase

Participants

ALL

Age Range

18 Years+

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).

Who Can Join?

Inclusion Criteria: * Aged >18 years * Primary knee OA * Requiring TKA * Suitable for either raTKA or mTKA * Capable to provide written informed consent * Capable and willing to complete outcome measures throughout study period Exclusion Criteria: * 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 * BMI >45 kg/m2 * Coronal plane deformity >15° varus/valgus on pre-op HKA radiograph * Fixed flexion deformity greater than 15° * Bone loss likely to require non-standard implants (e.g. stems, augments) * Severe deformity or ligament insufficiency likely to require constraint * Inability to comply with the required follow-up assessments or complete PROMs * Contraindications to any aspect of the surgical technique

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