A bit of pertinent background to begin: Fahey was an operating room nurse for 20 years who spent all day on her feet. Her hobbies included biking, hiking, and running.
Fahey’s life was running pretty smoothly until the day she felt the first pang of pain in her hip. She had just finished a race at the time.
“The first time I experienced hip pain was after a race,” she recalled in a Facebook video. “I didn’t think anything of it.”
Cue the first round of what ifs: What if she hadn’t been in that race? And what if she had been more concerned about the pain?
As Fahey further explains in her video, “I thought it [the pain] would go away so I kept pushing myself at work and with my weekly exercise routine, but I found myself slowing down. My range of motion kept decreasing and I couldn’t do the things I used to do.”
Insert a “should have” here: As a nurse, Fahey should have known better than to push through hip pain, however slight.
Perhaps Fahey should have known better. (Warning—more “what ifs” coming) But what if she had? What if she had recognized her hip pain was far more serious than she imagined? Would she have saved herself a non-work-related visit to the OR?
Does it really matter anymore? By the time Fahey consulted an orthopedic specialist, her hip was too far gone to save. Arthritis had worn down the cartilage to nothing, creating bone-on-bone contact that made almost any activity—even sleeping—an excruciating experience. Her only option at that point was a total hip replacement.
“Hip pain is exhausting. It is debilitating. It affected every aspect of my life,” Fahey said. “The pain eventually became so bad [that] I was looking forward to surgery. Looking back I can’t believe I waited so long.”
Looking back, Fahey shouldn’t have waited so long. (Spoiler: A “what if” is forthcoming) But what if she hadn’t waited? Would her outcome have been different?
What if she had consulted a different doctor? Would Fahey still have undergone a hip replacement?
More likely than not, considering the poor condition of her hip. The more interesting question, though, is whether Fahey’s physician choice affected the treatment solution.
Fahey received her new ball and socket prosthesis a few days before Christmas 2017 in a robotics-assisted procedure that is growing in popularity and proving more effective than traditional joint surgery. Within hours of the procedure, Fahey was testing her new body part, walking without pain for the first time in months.
“I’m so happy with my result, I feel better than I have in a long time. I can get back to the activities I love to do,” Fahey stated in her video. “I was in severe pain by the time I went into the hospital. I should never have put it off for so long. I would tell anyone not to wait as long as I did.”
Sound advice, certainly. Yet an argument can be made supporting procrastination, for Fahey’s dawdling ultimately necessitated a total hip arthroplasty performed via robotics-assisted technology.
Though it’s long been a science-fiction staple, real-world surgical robotics is a fairly new development in healthcare, originating in the mid-1980s with the invention of a stereotactic neurosurgery system. The technology found its way to orthopedics through the failures of early cementless hips, which typically fit poorly, had little or no stability, and lacked any bone ingrowth. To compensate for these deficiencies, Howard A. Paul, DVM, and William A. Bargar, M.D., developed ROBODOC, an image-based, active, autonomous milling system that allowed for more accurate preparation of the femoral bone and anatomic placement of total hip femoral components. Its first clinical use occurred in 1992.
Initial pilot studies for ROBODOC focused on dogs, but human trials quickly followed in 1992. European regulators greenlighted the system two years later, but it took more than a decade for the technology ROBODOC to pass muster with the U.S. Food and Drug Administration (approved for total hip arthroplasty in 2008).
While ROBODOC proved to be a solid launching pad for orthopedic robotic systems, the technology grew significantly in popularity with the 2004 founding of Fort Lauderdale, Fla.-based MAKO Surgical Corp. and its quick-to-market tactile surgical arm and patient-specific visualization platform. The company’s Tactile Guidance System initially was approved only for partial knee replacements, but soon gained acceptance for total hip arthroplasty.
“Orthopedic robotic-assisted surgery provides the patient with a precise and accurate surgical procedure,” noted Danielle Julian, M.S., senior research analyst at AdventHealth, a faith-based non-profit healthcare system that operates facilities in nine U.S. states. “Robotic surgery in orthopedics focuses on the precision of the surgical process. It prepares and completes surgeries with extraordinary precision.”
Clearly, precision is one of the main lures of orthopedic robotic technology, as the ability to more accurately prepare bone and place implants can help improve patient outcomes and potentially reduce overall procedural costs. Study data published last winter in the Journal of Comparative Effectiveness Research showed a $1,744 cost difference between robotic-assisted total knee arthroscopy (rTKA) and manual surgery ($5,234 rTKA vs. $6,978 mTKA). The study also found lower average post-procedural expenses for rTKA (11 percent, or $2,391) and higher overall index facility costs to payers undergoing traditional surgeries ($13,024 vs. $12,384 rTKA).
The Journal study additionally showed fewer 90-day readmissions for rTKA patients, with robotic-assisted procedures resulting in a 5.2 percent readmission rate compared with a 7.75 percent pace for mTKAs. Length of stay costs, however, were slightly higher for robotic-assisted surgeries ($10,570; 4.14 days vs. $9,696; 4.07 days mTKA).
“Based on our results, robotic-arm assisted surgery appears to be cost effective and provide added value for payers. As a result of these findings, robotic-arm assisted surgery can be an effective tool in managing existing value-based care programs while also offering value, given its potential to promote efficiencies through the EOC journey,” the study authors concluded. “As robotics is growing as a valuable adjunct to the surgeon in optimizing patient-specific arthroplasty, we suspect that its role will continue to expand as the benefit to value-based care continues to develop.
Considering the clinical and economic advancements we are seeing with robotic surgery today, in a time where there is increasing focus on reducing healthcare costs while improving patient experience, satisfaction, and outcomes, it is clear that robotic surgery is here to stay.”
Indeed it is, having gone mainstream since its ROBODOC days with the global dominance of da Vinci surgical systems (Intuitive), and the 2013 acquisition of MAKO Surgical by Stryker Corp. The $1.65 billion deal gave Stryker a sizeable lead in the race to command the multi-billion-dollar global robotics market.
Two years after acquiring Mako, Stryker received the FDA’s blessing for its hip replacement platform; total knee arthroscopy approval followed in 2017.
The Mako system uses computed tomography (CT) data to create virtual 3D models of a patient’s damaged joint and craft a pre-operative plan for implant placement. The plan takes into account such factors as patient size (physically), gender, leg angle, articulating services location, and overall bone movement.
That plan data is then programmed into Mako, which through haptic technology, operates only within surgeon-dictated boundaries. The system’s robotic arm is locked into place to ensure all surgical cuts are made within the pre-planned bounds; the surgeon maneuvers the arm and actually pushes the (bone) saw, but the Mako system limits the saw’s movement, cutting only within its programmed perimeters.
“The Stryker Mako robot, having well in excess of 350,000 procedures, uses something called haptics,” explained Robert Cohen, vice president of R&D and chief technology officer for Stryker’s Joint Replacement Division. “In haptics, we can have a cutting instrument on the end of the Mako robot arm that can assure a high level of accuracy and precision. We are the only company (with proprietary protection) that can have that cutting instrument guided by haptics. If we put an operating saw on the end of the robot arm, the robot arm aligns the plane of the saw blade toward where the bone resection needs to be in the patient for the proper placement and fit of orthopedic joint replacement implant. The surgeon executes the cuts. You get a different level of accuracy because you’re holding the instrument on the end of the robot arm. With haptics, we limit the migration of the saw blade—it only cuts where the bone is; the saw blade cannot make any excursion beyond the bone boundaries and damage soft tissues like muscles, ligaments or tendons, which makes for a more satisfied patient.”
And payers: Robotic-assisted surgery has been shown to reduce hospitalizations, OR time (by an average of 34 minutes), infection rates, pain/scarring, revision procedures, and readmissions—all of which translate to significant cost savings.
Those savings could grow, too, with greater incorporation of data analytics in existing and future robotic platforms. Stryker is actively enhancing the Mako system for such prowess, aiming to provide physicians with both pre- and post-operative information and analytics including co-morbidities, intraoperative changes, physical therapy, patient recovery, and implant performance.
“With connectivity, we can look at the data from the patient and the robot and now enter into a whole category of digital health. We can look at a pre-plan prior to surgery, we can look at the final position of the implant placement and import that out of the robot after the procedure. We are not using 2D X-rays, which are not very accurate. We use a virtual 3D bone model created from CT scans so it's an exact replica of the patient's bone,” Cohen said. “We can extrapolate that [data] to measure post-operative patient performance. We can put sensors on people to look at how well they walk, whether they are walking normally on both legs, we can look at their physical therapy—there’s a whole digital health aspect we can leverage here. Contrary, without the robot in the operating room and without knowing exactly the three-dimensional placement of the implant and the accuracy we are dealing with, all the other post-operative and pre-operative data wouldn’t be as meaningful.”
In addition to the digital health realm, Stryker also is planning to expand Mako’s reach into shoulder and spine applications, hence last September’s purchase of spinal robotics and navigation technology developer Cardan Robotics. Such an enhancement will put Stryker in direct competition with robotic-assisted platforms from Globus Medical, Medtronic plc, and Zimmer-Biomet Holdings Inc.
Globus markets its ExcelsiusGPS Robotic navigation system as a “revolutionary first” for spinal surgery. Designed to support minimally invasive and open orthopedic and neurosurgical procedures, the system allows for more efficient pedicle screw placement during spine and general surgeries. The tool is compatible with both pre- and intra-operative CT, as well as fluoroscopic imaging modalities; its benefits include minimal radiation exposure, streamlined workflow, and reproducibly-assisted implant placement.
Despite its comparably recent market entrance, the ExcelsiusGPS has amassed solid clinical evidence. Studies have found the system significantly reduces the duration of screw insertion in a cadaveric setting, averaging 3.6 minutes per screw compared to the conventional MIS average of 7.7 minutes per screw. Moreover, data published in the Journal of Robotic Surgery last spring showed a 99 percent screw placement success rate with no malpositions or postoperative OR returns.
“Clinical data shows improved accuracy of joint and screw placements, and reduced hospital stays, and reductions in readmissions with orthopedic computer-assisted devices, leading more hospital organizations and surgeons eager to adopt,” AdventHealth’s Julian stated. “Since the introduction of the da Vinci robotic platform in 2000...the use of this device has continued to grow year after year. I think that other specialties like orthopedics saw a gap and a need. A large amount of the front-runners in orthopedic devices have created robotic devices. Five of the 10 largest orthopedic device companies have introduced or obtained a robotic-assisted device.”
Those five include the world’s largest medical device developer (Medtronic), which launched its robot-assisted spinal platform in the United States last January, shortly after closing its $1.7 billion purchase of Mazor Robotics. The company had held a position in Mazor since May 2016.
Like most rival systems, Medtronic’s Mazor X platform aims to improve the precision of implant or instrument placement during surgery. And like Globus Medical’s ExcelsiusGPS, the Mazor X robot can be employed in either open or minimally invasive or percutaneous procedures.
Medtronic developed the Mazor X Stealth Edition robotic system in tandem with its acquisition target before their September 2018 merger. The system combines Medtronic’s Stealth software with Mazor’s existing robotic technology to deliver workflow predictability and flexibility through real-time image guidance, visualization and navigation informed by interactive 3D planning and information systems. It uses 3D cameras, guidance markers, and a robotic arm to monitor the location of tools and instruments in relation to the spine and to position them precisely as planned. In essence, Mazor X Stealth makes routine spine surgeries more efficient and complex cases more exacting, resulting in less “collateral damage” during spine and brain surgeries.
Since its debut last winter, the Mazor X Stealth system has been used to guide more than 1,000 (spinal) pedicle screw placements. It also helped boost Medtronic’s third-quarter 2020 Brain Therapies revenue by 8.6 percent.
Zimmer Biomet had the same hopes for its ROSA robotic system, but the technology hasn’t quite yielded the same results. Acquired nearly four years ago from French robotics developer Medtech SA, the ROSA platform encompasses knee, spine, and brain applications—a trifecta that, in theory, should give the company an edge over its competitors.
Should, but hasn’t...so far.
Zimmer received FDA clearance for ROSA-assisted knee, brain, and spine surgeries within the first three months of 2019, but has not yet commercialized all three applications. The company shelved its spinal robot debut last year to focus on knee system marketing, though that wound up being a limited launch. “We want to be very disciplined in our approach to launching a new robotic system to make sure that we do it right,” Zimmer Biomet CEO Bryan Hanson said last winter during a Q4 2018 earnings call with analysts. “We have the right education. We have the right service levels. And we will do that limited launch for, let’s call it six months. Post that limited launch is when we move into full launch. And that’s when the organization gets unleashed and we utilize that technology in full launch status.”
By the time that “full launch status” arrived, however, Zimmer was having some trouble with its robotic brain platform, an innovation that helps surgeons perform less invasive procedures than traditional craniotomies. A software glitch first identified in mid-September grew into a full-blown Class 1 recall by early November (2019); the defect reportedly jeopardized robotic arm positioning in the ROSA Brain 3.0 system.
Although ROSA helped grow Zimmer Biomet’s fourth-quarter 2019 and full-year knee sales, industry analysts claim that ROSA still lacks the market momentum to dethrone Stryker’s Mako robot. Differentiation between the two technologies could be key, as ROSA uses either X-ray data or an image-free analysis for pre-operative planning purposes and a smartphone app called mymobility (via iPhone and Apple Watch) to better connect patients and surgeons. The app is designed to improve the overall patient experience by helping them better prepare for their orthopedic procedures.
Still, Zimmer Biomet seems to be on track for eventual market share gains: “We expect ROSA to represent a formidable competitor to Mako and we expect ROSA to stop, and eventually begin to reverse [Zimmer Biomet’s] recent knee market share loss,” Needham & Co. LLC senior analyst Mike Matson said in evaluating the potential impact of ROSA’s full launch. “Over the long run, we believe ROSA should begin to drive market share gains for [Zimmer Biomet] as it also sees a portion of its placements with competitive surgeons primarily from [Johnson & Johnson] and [Smith & Nephew], since Styker offers Mako.”
Those two competitors, howbeit, are developing their own robotic technology, so the gains might be somewhat reserved. Johnson & Johnson has kept its robot-assisted ambitions under careful wraps, though the company appears to be strategizing a multi-faceted approach to the technology, based on recent deals. In addition to its 2018 acquisition of French robot-assisted surgical firm Orthotaxy, J&J purchased a robotic platform for bronchoscopic diagnostic and therapeutic procedures (Auris Health), invested in a novel beam therapy (HistoSonics), and forged a co-marketing, distribution, and R&D agreement with Beijing-based Tinavi Medical Technologies Co. Ltd.
Tinavi Medical has developed an arm-based robotic tool (TiRobot) for use in spine and trauma; the technology incorporates 3D imaging and optical navigation to plan an implant’s precise location. The company conducted a phase III clinical trial for TiRobot spinal fusions in 2016, and received approval in China that year for a third-generation form of the machine.
J&J is working with Tinavi Medical to co-market and distribute TiRobot in China, and the two companies also will partner on research and development (details of the agreement are scarce, though).
“We believe a broad range of specialties can benefit from robotic surgery, where there is room for automation to reduce variability, personalization to where you can map out a surgical plan for each patient, and efficiency and better clinical outcomes,” Jeff LaConte, senior director of Global Market Strategy, Robotics at DePuy Synthes, told Orthopedic Design & Technology. “DePuy Synthes believes that in addition to a robot it’s important to address the continuum of care with technologies that can enhance the pre-, intra- and post-operative orthopaedic experience for surgeons, patients, and healthcare systems. Powered by data insights and intelligent technologies, we introduced VELYS Digital Surgery as a means to deliver a more personalized care experience, greater insights for decision-making, and increased precision and consistency with the aim of improving patient outcomes and satisfaction, as well as optimizing efficiencies. A robotic surgical offering for knee replacement will become a centerpiece of the offering.”
With its relatively late market arrival (perhaps this year), that centerpiece will have to compete for market share with both established systems like Mako, and more recent additions like ROSA, Smith+Nephew’s NAVIO system, Corin’s OMNIBotics technology, and THINK Surgical Inc.’s TSolution One platform.
The latter tool features CT-based, 3D pre-surgical planning software for knee replacements. The pre-surgical planning allows physicians to design and prepare, in a virtual environment, a patient’s unique joint replacement plan using a choice of implant options. The FDA cleared the TSolution One system for total knee replacement last October; the robot was approved previously overseas, and has been used in more than 550 procedures in the Asia-Pacific and European markets.
Corin’s OMNIBotics platform, by contrast, dwarfs THINK Surgical’s robot-assisted tool (and Mako’s, in fact), having recently completed 25,000 total knee arthroplasties, including 5,000 procedures using the BalanceBot ligament balancing robotic device.
The company’s BalanceBot enables surgeons to predictively balance knee joints by understanding feedback from soft tissue and ligaments throughout the entire range of joint motion. BalanceBot is used to accurately predict the impact of implant positioning on knee gaps in flexion, extension, and mid-flexion. More precise ligament balance allows surgeons to target knee gaps that correlate with better outcomes and less pain. The platform also can be used intra-operatively to assess a patient’s overall knee stability throughout the full range of motion with the joint in-situ.
“The patient benefits for Corin’s robotic platform include less blood loss, which may lead to a quicker recovery, and no IM [intramedullary] violation, so there is less risk of embolism,” explained Dan Cipolletti, Corin Ltd.’s global marketing communications manager. “Precision bone cuts allow for better joint alignment, which helps improve overall stability and longevity. Robotic ligament balancing helps maintain proper soft tissue balance for TKR, and soft tissue balance has been shown to improve overall patient satisfaction and reduce pain.”
Smith+Nephew, meanwhile, is working on updates to its handheld NAVIO system. The platform’s newest version—NAVIO 7.0—aims to improve the surgeon experience through a new user interface, expanded surgical preferences, and streamlined workflow. The update also will incorporate the ANTHEM Total Knee System for Emerging Markets onto NAVIO.
NAVIO has been a pillar of Smith+Nephew’s robotics portfolio since it purchased the technology’s birth parent firm, Blue Belt Technologies, in 2016. Smith+Nephew added a total knee arthroplasty application to NAVIO the following year, and is now working to install Brainlab’s hip software onto the 7.0 version (the London-based firm purchased Brainlab’s orthopedic joint reconstruction business last March).
“I’m excited about co-inventing the future of digital surgery with our new partner, and expanding the reach of our technology to ambulatory surgery centers and their patients,” Stefan Vilsmeier, Brainlab president and CEO, stated after the deal. “Computer-assisted surgery is the foundation of any powerful robotic solution and sophisticated software will drive superior robotic applications.”
Long live the robots.