Implant costs have been proposed as the primary driver for increasing hospital charges following elective primary TKA, accounting for nearly 40% to 50% of the total costs per inpatient episode of care billed to Medicare.⁹,¹⁰ Furthermore, implant prices have increased significantly, while substantive evidence demonstrating improved clinical or functional outcomes with newer, novel implants over previous generations remains equivocal.¹¹ As a result, select healthcare organizations have mandated value-based care initiatives, which have led to aggressive implant price restructuring. In 2011, New York University Langone Orthopedic Hospital (NYULOH) developed an implant cost-containment program.¹² A non-negotiable implant price ceiling was implemented, compelling vendors to compete for the hospital’s market share. Eventually, all vendors decided to meet the implant price. Through this program, NYULOH reduced the average TKA implant cost, effectively decreasing the overall costs of TKA by 25.94%. After its first year, NYULOH saved $2 million through implant price negotiations for TJA alone. Similarly, an initiative at the Lahey Clinic demonstrated improved financial performance following the implementation of price negotiations with vendors. In their model, a single price per case purchasing program was developed. Vendors were required to provide all knee implants at one standard prenegotiated price for every TKA case irrespective of the implant being used during the cases.¹³ The price was based on historical data on the use of implants at that institution. They successfully reduced the cost of knee implants by 23% at their institution.¹³

Fueled by the financial success of TKA, implant vendors have continued innovation while also producing an abundance of new medical device designs each year. However, as these new medical devices come to market at higher cost, questions have been raised concerning cost-efficacy and safety. The majority of these devices are often approved through the Food and Drug Administration’s (FDA) 510(k) clearance process, a mandate passed by congress in 1976 as part of the FDA’s Medical Device Amendments (MDA).¹⁴ The 510(k) clearance process is a pragmatic approval
process for medical devices developed due to concerns for restricting continued medical innovation. This process allows for novel medical device approval based on claims of device similarity to preexisting medical devices on the market. Of even greater concern is the fact that the majority of the preexisting devices available on the market for comparison were also approved through a streamlined process for unregulated devices in 1976 as part of the MDA. As a result, there is a lack of supporting data for the durability, safety, and outcomes of these devices.¹⁴,¹⁵ Studies supporting these existing devices may lack clinical trials altogether and in some cases, the preexisting device may also be approved through the 510(k) clearance process.⁸,¹⁵ Due to the simplicity for acquiring approval of novel medical devices, approximately 35 TKA systems are approved by the FDA annually, further contributing to the financial burden of TKA.⁸ However, as new medical devices continue to be brought to the market, there is a lack of scientific evidence that demonstrates conclusive clinical superiority over currently available devices.

With rising healthcare costs, it is critical to evaluate the value of medical device innovations in comparison to traditional devices that have existing evidence of safety and efficacy. Medical device innovations should be directed at solving unaddressed clinical challenges or should demonstrate improvements over previous iterations, such as improved range of motion, patient satisfaction, and survival for TKA implants.¹⁶ Furthermore, introduction of these new medical devices can result in significant price variations between both new and old medical devices. Institutional cost-containment programs should therefore concentrate on maintaining negotiated prices when presented with new medical technologies, particularly when these new devices have yet to demonstrate evidence for clinical superiority over previous models, provide only theoretical clinical justification over the current standard of care, and have a currently unproven track record.

Modern day technological advancements have improved many aspects of medicine. In orthopedic surgery, the possibility of improving clinical and functional patient outcomes by reducing human error and improving surgical precision has been promising. Current innovative techniques center around the use of computer and robotic-assisted orthopedic surgery to improve precision, reproducibility, radiographic alignment, and implant positioning for TKA.¹⁷,¹⁸,¹⁹ However, recent studies on the use of computer and robotic-assisted surgery fail to identify reproducible improvements in clinical or functional patient outcomes.¹⁸,¹⁹,²⁰,²¹,²²,²³,²⁴,²⁵,²⁶,²⁷ In addition, long-term clinical outcomes in orthopedic surgery and the economic implications secondary to these technological innovations are yet to be clearly defined. The vast majority of existing literature has failed to demonstrate any substantial clinical advantage such as superior patient-reported outcomes, range of motion, survival, or revision rates attributed to the improvement in alignment achieved by the engagement of computer and robotic-assisted TKA.¹⁸,¹⁹,²⁰,²¹,²²,²³,²⁴,²⁵,²⁶,²⁷ Furthermore, concerns about the financial burdens secondary to increased surgical times, initial capital investment, and the additional training required with the use of the computer and robotic-assisted surgery have contributed to reservations about the use of these modern technological advancements as routine standard of care. One potential benefit of this technology is the possible use in learning curve improvement and surgeon education which may be used to provide immediate cutting precision and implant placement feedback.²¹

Computer-assisted navigation systems exchange subjective decisions into precise, calculated, patient-specific surgical actions. Computer-assisted systems require less initial capital investment in comparison to robotic-assisted systems.²⁵ However, one study by Beringer et al described an additional expense with computer-assisted navigation ranging from $600 to $2000 per arthroplasty case.²⁸ Good clinical and functional outcomes following computer-assisted TKA have been reported.¹⁸,¹⁹ Despite improving radiographic outcomes, it remains unclear whether computer-assisted navigation improves clinical outcomes or patient satisfaction in comparison to conventional methods.²⁵

Robotic-assisted systems reportedly restore component alignment with greater accuracy than computer-assisted navigation; however, there is a paucity of evidence supporting improvement in clinical and functional outcomes.²⁵,²⁹ Additionally, robotic technology requires a large initial capital investment for the robot, training, and software. There are currently four commonly used robotic platforms in the United States including Mako (Stryker, Mahwah, NJ), Navio (Smith and Nephew, London, UK), THINK (THINK Surgical Inc, Fremont, Ca), and OMNI (OMNIlife Science Inc., Raynham, MA). The initial cost for the robot is unique to each and therefore varies significantly. Capital investment for a robot ranges from $400,000 to $2.5 million.³⁰,³¹,³² For example, the Mako robotic system (Stryker, Mahwah, NJ) available for use in orthopedic surgery may cost upwards of $930,000 with an expected lifespan of merely 5 years.³¹ There is also an additional inherent cost per year for the associated service contract bringing the total cost to an estimated $1.362 million. Furthermore, software licensing and
annual maintenance for these robotic-assisted devices in general can range from $40,000 up to $250,000.³⁰,³¹,³² An additional variable expense inherent to robotic-assisted systems is attributed to disposable surgical kits. A study by Moschetti et al reported a $2743 increase in cost per surgical case for unicompartmental knee arthroplasty with the use of Mako.³¹ Similarly, Belleman et al reported an additional $1360 per case for ancillaries required by the robot.³² Many of the commonly used robotic-assisted systems require preoperative imaging to match anatomy during surgery, therefore further increasing expenditures, radiation exposure, and preoperative planning times and costs.²⁵ It is not yet clear whether the theoretical improvements in precision accomplished with the use of these robotic systems necessarily translate to objectively improved outcomes in TKA. Therefore, reservations persist in relation to the cost-effectiveness of these technological advancements.