EARLY VALUE ASSESSMENT PROGRAMME

The ApolloKnee robotic-assisted surgical platform is indicated for total knee arthroplasty (TKA) and replaces the OMNIBotics System. This technology includes BalanceBot technology, which captures soft tissue data through a full range of motion to help with alignment and balancing of the knee. No preoperative imaging is needed and the platform is directly affixed to the person having surgery via a fixation system, using indirect cutting that aligns with a guide.

The CORI Surgical System is indicated for primary TKA, partial knee arthroplasty (PKA) and total hip arthroplasty (THA), as well as total knee revision. It replaces the NAVIO Surgical System. This technology is handheld and allows image-free 3D modelling of the joint in surgery. It requires the surgeon to directly cut the bone with boundary control provided by the system.

The Mako SmartRobotics system is indicated for TKA, PKA and THA. This technology requires a preoperative CT scan that is sent to a specialist to create a patient bone model. This is uploaded to the system to guide the surgeon. The technology uses an arm-based cutting tool attached to a moveable base station and requires the surgeon to directly cut the bone with haptic boundary control provided by the system.

The ROSA Knee System is indicated for TKA. This technology has optional preoperative imaging that can assist with placement of the robotic arm. The technology provides intra-surgery feedback, uses an arm-based cutting tool attached to a moveable base station and uses indirect cutting that aligns with a guide.

The SkyWalker system is indicated for TKA and THA. This technology requires a preoperative CT scan for planning. It uses an arm-based cutting tool attached to a moveable base station and requires direct cutting.

MicroPort MedBot did not respond to requests for information but informed NICE that the SkyWalker system is being prepared for introduction to the NHS.

The VELYS Robotic-Assisted Solution is indicated for TKA. This technology provides intra-surgery feedback and imaging, uses an arm-based system that is attached to a base station and requires direct cutting with boundary control provided by the system.

The technologies are indicated for knee or hip joint replacements, which are the most common orthopaedic procedures done in the NHS. Knee and hip joint replacement surgery involves replacing damaged parts, or the whole, of the knee or hip joint with metal or plastic implants. The most common reason for a joint replacement is osteoarthritis. Other less-common causes include, but are not limited to, rheumatoid arthritis, gout and injuries, all of which result in joint pain, stiffness or both. In the past year there were about 125,000 knee procedures and over 100,000 hip replacements done in the UK (National Joint Registry 20^th Annual Report, 2023). The Royal College of Surgeons' (RCS) Future of Surgery report predicted that the rapid expansion of robot-assisted surgery across the UK will increase access for many people.

The NICE guideline on joint replacement (primary): hip, knee and shoulder describes the current care pathway. Conventional surgery relies on 2-dimensional X-ray images that allow surgeons to map the target site for the implant and what it will look like after implantation. Extra- or intra-medullary jigs (guides) are used to make cuts at a predetermined angle. The cuts are made by the surgeon, removing the damaged part of the bone using a manually controlled saw. Once removed, implants are aligned and manually placed over the cuts, using guides and tools to achieve the best fit. The process is reliant on a surgeon's skill and judgement, and this may result in variations in precision and alignment.

The comparator is conventional surgery using manual techniques. Some surgeons may use computer-assisted navigation to help with orthopaedic procedures, but this is not standard care in the NHS so it was not included as a comparator.