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

RecruitingNAAges 18 Years - anyAllGolden Jubilee National Hospital
NCT07551856 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 mot

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📋 Eligibility rules (as published)
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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What it tests

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

1 site
Golden Jubilee University National Hospital
Glasgow, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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