But do they represent the future or an expensive boondoggle?
While using robots for surgery has been on the periphery for more than two decades, they have become more central to the orthopedic field over the past several years, especially with the purchase of Mako by Stryker
Robotics falls into a larger category of computer-assisted orthopedic procedures, which includes navigation, imaging, as well as cutting and milling of bone. The use of robotics first caught on in orthopedics in conjunction with the introduction of minimally invasive joint replacements. It gave a means of imaging the joint and navigating inside the body through smaller incisions to achieve more precise placement of implants. This is meaningful because it offered surgeons a way to study the joint and formulate a plan for how to prepare it for replacement before the patient entered the operating room. Conventional wisdom held that this kind of upfront planning would lead to smoother and shorter procedures, which would also be less expensive, because each minute in the operating room costs approximately $62.1
More recently, robotic systems have been developed to assist surgeons in the actual cutting and grinding of bone surfaces. Similar to the navigation systems, the concept is that robotic milling would allow for more accurate planning and a better fit of the bone to the implant. Better fit should ultimately translate into a better clinical outcome that minimizes the risk of misalignment or suboptimal placement that can cause pain, leave the patient with differences in limb length, or introduce wear patterns that, over time, cause the implant to loosen and fail prematurely. There is also the belief that the precision that robotic systems offer can help compensate for suboptimal surgeon skill, leading to more predictable and reproducible outcomes. Considering orthopedic surgery remains one specialty where individual surgeon skill wields an outsized effect on outcomes, practitioners are interested in ways to raise the skill level across the board.
There is much controversy around robotics and computer-assistance among surgeons. At first blush, it appears the field is divided fairly evenly between those physicians who believe robotics is critical to the future of orthopedic surgery and those who remain skeptical of the clinical value and significant cost of these systems.
Challenges to Widespread Adoption
With little consensus among practitioners, we see considerable hurdles to the widespread adoption of robotics in orthopedics. As with much in orthopedics, the research on clinical outcomes or any related cost savings is thin at this point. Data convincingly suggest that navigation systems do indeed lead to more accurate placement of joint implants. However, researchers have not yet been able to demonstrate how robotics leads to any difference in clinical outcome. That is, we’re seeing no difference in functionality or patient satisfaction whether robotic navigation is used or not. The jury is still out on whether robot assistance with bone milling can lead to significantly improved outcomes. It could easily take another five to 15 years to collect enough clinical data to move practitioners to consensus on the value of robotic systems such as Mako.
The absence of compelling clinical data leaves considerable obstacles to establishing reimbursement for special navigation or robotic assistance. The financial aspect of robotic systems can be a tough pill to swallow. For example, the Mako robot (which assists the surgeon in cutting and milling) is priced close to $1 million, with another $100,000 in annual service costs. But the reimbursement for hip and knee replacement does not include anything extra for the use of a robot. We do not expect this to change until there is enough consistent clinical data to sway consensus.
Moreover, the application of robotic technology in other sectors, such as industrial manufacturing, has typically led to efficiencies in terms of lowering labor inputs and lowering the time required to complete the product. Thus far, robotic systems in orthopedics has delivered neither benefit.