Manual Arthroplasty Versus VELYS Robot-assisted Functional Alignment in Total Knee Arthroplasty
brief summary
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).
detailed description
This multicentre, pragmatic, parallel-group, blinded RCT will compare VELYS robot-assisted functional alignment with conventional total knee arthroplasty. The trial will employ a clearly defined, reproducible surgical protocol that will incorporate evaluation of the study cohort using: established clinical and patient-reported outcome measures (PROMs); gold-standard three-dimensional (3D) motion analysis to objectively evaluate functional outcomes; detailed examination of intraoperative knee kinematics, pre-/post-operative hip-knee-ankle radiographic data, and healthcare system effects including economic, efficiency, and human factor measures.
Objectives
The primary objective is to compare knee-specific health outcomes in patients undergoing TKA performed with VELYS robot-assisted (raTKA) using functional alignment versus TKA performed manually (mTKA) using conventional instrumentation. The primary outcome measure will be differences between the two intervention groups (using an intention-to-treat approach) with regard to change in Forgotten Joint Score (FJS) preoperatively versus 6 months post-surgery. The secondary objectives are to:
1. Compare PROMs (FJS, EQ-5D-5L, Oxford Knee Score \[OKS\], satisfaction \[numeric rating scale; NRS\], 4-part Likert scale\], pain \[101-point scale VAS\]) at 6 weeks, 6 months, and 12 months; 2. Correlate these outcomes with radiographic alignment and intra-operative data; 3. Evaluate biomechanical outcomes using motion analysis laboratory assessment; 4. Functional and activity-related outcomes; 5. Evaluate the economic and efficiency effects of imageless raTKA relative to mTKA; 6. Evaluate the human factor effects of introducing a new RAS into healthcare teams; 7. Assess surgical safety and the incidence of adverse events in both groups.
Null hypothesis The null hypothesis is that functionally aligned raTKA using the VELYS imageless system does not result in a greater early improvement in knee-specific outcomes, as measured by change in Forgotten Joint Score at 6 months, compared with conventional mTKA.
Study design The study is designed as a multicentre, pragmatic, parallel-group blinded RCT. There are nested modular study components, including: an internal pilot to determine safety and practicability; a motion analysis evaluation, and a task load, efficiency, and clinician perspective evaluation. The lead centre for the study will be the Golden Jubilee University National Hospital (GJUNH). Additional centres will be based in the United Kingdom and Irish regions. All participating surgeons are high-volume arthroplasty surgeons (performing \>100 knee arthroplasties annually) and have extensive experience with robot-assisted surgery.
official title
Manual Arthroplasty Versus VELYS Robot-assisted Functional Alignment in Total Knee Arthroplasty (The MARVEL Project): A Pragmatic, Multicentre, Blinded Randomised Controlled Trial With Multi-domain Investigations