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

Not Yet RecruitingNA

Sponsor: Golden Jubilee National Hospital

Conditions: Knee Osteoarthritis, Osteoarthritis (Knee), Osteo Arthritis of the Knee, Osteo Arthritis, Osteoarthritis (OA)

Interventions: Robot-Assisted Functionally Aligned Total Knee Replacement, Manual Total Knee Arthroplasty

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Glasgow, Scotland, United Kingdom