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    Features

    Robot Recharge: Orthopedic Surgical Robotics Update

    Orthopedic implant developers are supplementing their robotic systems with connected care solutions intended to manage patients’ entire surgical experience.

    Robot Recharge: Orthopedic Surgical Robotics Update
    ROSA Robotics is a multi-application platform that uses Zimmer Biomet’s implants and data technologies to provide real-time insights to optimize patient outcomes. Image courtesy of Zimmer Biomet.
    Robot Recharge: Orthopedic Surgical Robotics Update
    Rosa is cleared to perform total and partial knee replacements, total hip replacements, and neurological and spine procedures. Image courtesy of Zimmer Biomet.
    Michael Barbella, Managing Editor03.24.22
    A prayer for peace.

    That was the intention of the Sherman Brothers’ most renowned song six decades ago as the world weathered a 35-day standoff between the Soviet Union and United States. Working under strict parameters from iconic animator/entrepreneur Walt Disney, the pair was tasked with penning a simple paean to global unity.

    “He said, ‘I want it to be a simple song that is a salute to the children of the world because they are the hope of the future. They have to learn as youngsters how to live together and share the world because that’s all we’ve got,’” Richard M. Sherman told the non-profit music rights group BMI in a May 2014 interview. “As we worked back in our office...we said, ‘Well, Walt said the small children of the world are the hope of the future. What’s key to that? Let’s learn to live together, not kill each other, after all we live in a small world, that’s where we live after all, small, all, ooh! That rhymes.’ Then we said, ‘It’s a small world after all, let’s not kill each other! No, we don’t have to say that, it’s a small world after all...let the mind say the rest of it.’”

    The mind, actually, is too consumed by those first six words to think of anything else. Nearly half the song’s lines simply repeat the title: “It’s a Small World (After All).

    On its journey to earworm status, though, the Sherman Brothers’ redundant chorus has become an ode, of sorts, to cosmic synchronicity.

    Though the mountains divide

    And the oceans are wide

    It’s a small world after all


    Small indeed. Small enough, in fact, for Jiangsu province, China resident Xu Weifang to have rescued a drowning father and son, 30 years apart; 10-year-old Staffordshire, England lass Laura Buxton to have found her namesake 140 miles away by helium balloon messaging; and Esther Grachan to have found her soulmate via an autographed $1 bill.

    The world also is small enough for Dennis C. to have found a better treatment option for his osteoarthritic hip.

    The Sorrento, Fla., resident was a few weeks from replacing his hip several years ago when he learned of a robotic procedure that halves recovery times. The information came from his wife’s ex-husband, living in Providence, R.I.

    The ex-husband had recently undergone robotic hip replacement surgery and was touting its benefits during a visit with Dennis’s wife and their daughter. Upon returning to Florida, Dennis’s wife researched qualified robotic joint replacement surgeons and found one in their area—Ronald V. Hudanich, D.O.

    During their initial consultation with Hudanich, Dennis and his wife discovered the doctor had recently attended a robotic surgical training session in Providence with Robert C. Marchand, M.D., the physician who replaced the ex-husband’s hip.

    It’s a small world after all.

    Like his training comrade, Hudanich used robotic surgical technology from Kalamazoo, Mich.-based Stryker Corp. to replace Dennis’s diseased hip. Such technology has become a staple among Stryker and other major orthopedic companies as they jockey for share of a market increasingly fixated on customized solutions and value-based care delivery.

    The promise this technology imparts on joint replacement procedures as well as minimally invasive approaches and personalized medicine primes the sector for explosive growth in the next several years. Insight Partners data forecasts the market to balloon 24.1 percent annually through 2025 to reach $2.11 billion in value.

    “I don’t think it’s a market share battle as much as market expansion,” Needham & Co. analyst Michael Matson told the press last fall. “All the companies are riding this wave.”

    But only Stryker has become an expert surfer.

    Riding the wave longer than its rivals, Stryker entered the robotics swells in 2013 with its $1.65 billion buyout of Mako Surgical Corp., developer of a mechanical surgical arm and patient-specific visualization technology. The platform is used for total and partial knee replacements and total hip replacements.

    Mako’s initial rollout was slow, as potential customers and surgeons were reluctant to embrace the technology. Stryker CEO Kevin Lobo remembers the Mako deal being so heavily criticized at the time that even the company’s most loyal clients questioned its rationale.

    “The idea of robotics in orthopedics, most customers told me, ‘We don’t need it.’ The consultants that we work with, the orthopedic surgeons that use our  products said, ‘We’re not asking for it,’” Lobo reminisced to Chief Executive two years ago. “But that’s one of the areas where there were a few surgeons who really believed in it. As a new person coming into orthopedics, I said, ‘These implants are all good now. But it’s not about the implant now, it’s about how well the knee is balanced and how much soft tissue we’re disrupting.’ If we can do a less invasive procedure, the surgeon can have better information with a 3D plan, so they can make it more personalized. It’s gonna be a better outcome. But that was more of a bet that we made.”

    It was a wise gamble on Lobo’s part: The Mako system gives surgeons the flexibility to customize large joint implants, and ensure both accurate alignment and placement, all of which begets safer surgeries and improved patient outcomes.

    Mako’s multiple benefits are evidenced in numerous clinical studies. Data equate Mako Partial Knee and Total Knee procedures with lower postoperative pain scores, shorter hospitalizations, less physical therapy, and greater patient satisfaction than conventional (manual) surgeries. Trial results also prove the superiority of robots to humans: Compared to manually-placed implants, robotic-assisted total knee arthroplasties typically were 47 percent more accurate to plan for tibial component alignment, 59 percent more accurate to plan for tibial slope, and 36 more accurate to plan for femoral component rotation.

    “In clinical studies comparing navigated total knee repair to robotic-assisted total knee, we’ve seen that the robotic-assisted total knee had significantly improved postoperative pain, reduced need for opiate analgesics, and reduced length of stay,” said Erik Todd, vice president and general manager, Robotics and Enabling Technologies, at Stryker. “Studies also demonstrated that robotic-assisted total knee patients had greater improvement in their functional activity, based on walking and standing scores at both four to six weeks and six-month follow-ups, when compared to conventional total knee applications.”

    Similar proof exists for Mako Total Hip, cleared by the U.S. Food and Drug Administration (FDA) in March 2015. Studies have found Mako to be better than manual THA at placing hip components more accurately to the plan and preserving bone through smaller acetabular cup use.

    Robotic-assisted technology like Mako allows surgeons to perform joint replacements with more precision, flexibility, and control compared with manual techniques. Many of these solutions use CT scans to create computerized 3D anatomical models that ultimately determine the precise measurements of angles, rotations, soft tissue, and bone for exact component placement. During surgery, the robotic arm controls bone cut direction to a fraction of a millimeter, in line with the pre-operative plan.

    Like some solutions currently on the market, Stryker’s Mako system uses computed tomography scans to create pre-operative surgical planning models. But Mako also distinguishes itself from rivals through its AccuStop haptic technology, which limits bone resecting to the pre-defined, pre-calculated area. Mako’s robotic arm gives resistance, an audible warning, and ultimately stops if the cutting tool moves beyond the pre-operative plan’s boundaries.

    Along with its AccuStop haptic technology, Mako also reportedly is the only robotic bone resection system that can cut with a saw, burr with a burr, and ream with a reamer.

    Medtronic’s Mazor X robot has pre-operative planning capabilities too, enabling 2D fluoroscopic projections from standard C-arms to be processed and converted into volumetric 3D images. But Mazor X also features a navigation system for tracking surgical instruments during procedures. StealthStation S8 includes 3D cameras and electromagnetic sensors for tracking tool location, related tracking algorithms and software to process data, and the ability to merge data from different imaging sources for easy guidance, according to the company.

    In addition, Mazor uses the Midas Rex MR8 electric high-speed drill system for improved trajectory precision that starts with pilot hole creation. Medtronic designed the drill’s attachments and dissecting tools to drill with accuracy at speeds up to 75,000 rpm. Midas Rex MR8 integrates with the StealthStation S8 system and can be used in spine, cranial, ENT, and other surgical procedures.

    Medtronic gained the Mazor X surgical platform through its $1.7 billion acquisition of Caesarea, Israel-based Mazor Robotics in 2018. The system is cleared for spinal surgery in Canada, Europe, and the United States.

    Smith+Nephew plc bought its way into the orthopedic robotics market as well, securing the NAVIO Surgical System via its $275 million bid for Blue Belt Holdings Inc. in late 2015. NAVIO’s handheld approach to robotic-assisted knee surgery is unique to the sector (though Lobo would disagree), as it is significantly smaller and less expensive than competing platforms featuring robotic arms.

    NAVIO’s individuality extends to its pre-operative planning program and implant alignment capabilities. The system eliminates the need for CT scans and intermedullary rods through advanced computer software that maps the surface of diseased bone and cartilage.

    In the six years since acquiring the NAVIO technology, Smith+Nephew has bolstered its robotics platform with CORI, a next-generation solution with twice the cutting volume and quadruple the camera speed of its predecessor. CORI also incorporates the company’s Real Intelligence software for pre-operative planning, surgery, and post-operative assessment. RI.INSIGHTS enables orthopedic surgeons to benchmark robotic procedural experiences with users globally to optimize surgical planning and improve patient-reported outcome measures. RI.INSIGHTS collects anonymized intra-operative details and presents surgeon case data through a secure portal, which can be reviewed with independent post-operative patient outcomes, thus allowing surgeons to gain and readily apply insights from their robotics-assisted procedures.

    The CORI platform received FDA 510(k) clearance in February 2020 for both unicompartmental and total knee arthroplasty, and nabbed an expanded indication earlier this year for total hip arthroplasty. Additional applications are planned as well.

    “The Real Intelligence ecosystem is a game-changer for Smith+Nephew,” Jimmy Chow, M.D., hip and knee specialist at the Phoenix-based Orthopedic Institute of the West, said last fall. “As a surgeon, I get a personalized experience that gives me the confidence and assurance I’m performing the most precise and efficient procedure...What more can you ask for? The orthopedic space is becoming a technology space, and this suite of pre-, intra-, and post-operative solutions all designed to work together is truly remarkable.”

    The industry’s technological transformation is spawning a digital revolution, of sorts, among the robots, arming them with big data capabilities, artificial intelligence (AI)-powered anatomical classification and predictive analysis prowess, and remote care management capacity.

    Johnson & Johnson’s VELYS robot, for example, is complimented by the VELYS Digital Surgery Platform, an assortment of digital tools and data insights designed to improve patient care. Among the platform’s various features is VELYS Insights and ONETRIAL Analysis. The former is an integrated support solution that connects care teams to real-time, patient-specific data to help inform decisions both before and after orthopedic procedures. VELYS Insights includes two key capabilities: Care Coordination to help improve case management, surgery readiness, and workflow efficiencies; and Patient Path Management, designed to help care teams educate, support, communicate with, and remotely monitor patients using the Patient Path mobile app during their knee, hip, or shoulder replacement surgery.

    The ONETRIAL Analysis feature enables intraoperative data-driven decision making for patients positioned laterally, in addition to existing capabilities for the anterior approach hip replacement technique.  
             
    Similarly, Zimmer Biomet Holdings Inc. connects joint replacement patients and caregivers through its ZBEdge Connected Intelligence Suite and mymobility app. Intended to enhance joint replacement surgeries for both patients and providers, ZBEdge encompasses advanced surgical robotics (ROSA, cleared to perform total and partial knee replacements, total hip replacements, and neurological and spine procedures), patient-focused digital applications, and data analysis software.

    Included within the ZBEdge Suite is the OrthoIntel Orthopedics Intelligence Platform, which analyzes patient data and compares it with input from a global network of mymobility participants with similar anatomies and/or demographics. This information helps surgeons better understand typical progress among patients so they can apply those insights to their current joint replacement candidates.

    One of ZBEdge’s newest features is Persona IQ, which combines Zimmer Biomet’s Persona knee implant with Canary Medical’s proprietary tibial extension sensor technology for measuring and determining motion range, step count, walking speed, and other gait metrics. Once implanted, the device records and wirelessly transmits metrics, allowing surgeons to assess post-surgery recovery progress.

    The company’s mymobility app leverages Apple Watch and iPhone sensors to measure patient activity and post-operative progress. The pre- and post-operative data collected is combined with intra-operative statistics from those undergoing joint replacements with ROSA. This data is consolidated and analyzed by the OrthoIntel Orthopedic Intelligence Platform to gain new clinical insights.

    “Data linking intra-operative treatment with patient post-operative recovery represents an exciting opportunity to examine how robotic surgical systems might improve patient outcomes,” Liane Teplitsky, Zimmer Biomet's president of Global Robotics and Technology & Data Solutions, told Orthopedic Design & Technology. “Data from ROSA and mymobility was recently published in Orthopaedic Proceedings. The authors observed that patients who had less than 1 mm of medial laxity in flexion had significantly fewer step counts at week six post-operatively, but there was no difference in KOOS JR scores as a function of tightness (p>0.05). As this data set continues to mature, we’re excited about the possibility of it to shed new light on the ways that surgeons and care teams can augment their clinical decision-making with objective data.”

    “Robotic surgical systems are an integral piece of creating a comprehensive view of orthopedic care informed by data,” she continued. “Robotic systems are designed to accurately position implants in a precise location based on unique patient anatomy. This is a treasure trove of information, and the ability to connect this intra-operative data with post-operative recovery metrics is increasingly important.”

    Medtronic is accessing that treasure trove of data with the AI-driven surgical planning and predictive modeling tools it obtained from Medicrea (purchased in November 2020 for $243 million). The French firm’s 6,000-count 3D image repository supplies clinicians with optimal curvature data post-surgery; this information could help clarify the ways rod and screw placement can impact adjacent regions. 

    Stryker, meanwhile, is tapping that big data repository with smart implant technology from Orthosensor, last winter’s acquisition target, and its RecoveryCOACH application.

    “We are seeing some interesting trends in terms of managing an entire patient’s episode of care—inclusive of pre-operative, intra-operative, and post-operative planning,” Todd said. “Understanding all the factors of a patient’s life that could impact recovery is key. Stryker uses an application called RecoveryCOACH—our patient engagement and patient-reported outcomes collections portal and app—to provide surgeons and their teams with patient information such as health and home environments, and other factors that may impact their recovery both before and after surgery. We’re now seeing an extension of patient management that’s happening before the operation and extending through physical therapy into post-operation.”

    Robot Power 
    Orthopedic robots coordinate motion and feedback across all surgical controls, mechanical arms, cameras, and instruments to deliver smaller incisions, precise implant positioning, and minimal bone cuts (when possible).

    Such outcomes would be difficult, if not impossible, however, without the motors and motion control technology inside these robotic platforms. While a wide range of motors can be found inside a surgical robot, most systems contain high-power, high-precision direct drive motors.

    The increasing precision and maneuverability of robotic solutions is raising the bar for finished parts inside the machine. “Newer technology is allowing parts to be closer to a finished good, requiring reduced finishing processes,” noted Dave Marinkovski, senior robotic automation lead for Acme Manufacturing, an automation technology provider based in Auburn Hills, Mich.

    One of the most significant drivers of robotic motor innovation, not surprisingly, is miniaturization. Smaller tools and robots (think Smith+Nephew’s NAVIO and CORI handheld systems) require smaller motors with higher output power.

    “One of the primary technology drivers in advancing orthopedic surgical treatment is the miniaturization of motor technology used in surgical tools and end effectors,” explained John Chandler, control systems director for Faulhaber Micromo LLC, a provider of high-precision, high-performance custom micro motion system solutions. “Given smaller motors, design engineers are able to produce surgical tools that are more ergonomic. A more ergonomic tool design reduces fatigue for the surgeon. Alternatively, if a tool or end effector is robotically controlled, then a smaller tool size and weight subsequently reduces the size, mass, and cost of all robotic structural elements needed to support it. Simply put, whether handheld or robotically controlled, it really pays to have a small, powerful motor inside a surgical tool or end effector.”

    The power is key, though.

    “There’s always been a push to make things physically smaller with longer battery life, and more capable of withstanding multi-step cleaning processes, including autoclavability” said Peter van Beek,  Business Development Manager at maxon, a Swiss manufacturer and supplier of high-precision drive systems. Its motors are used in active implants, insulin pumps, surgical robots, power tools, respirators, ventilators, and prostheses. “Historically, in the 30 years I’ve been at maxon, what a one inch diameter motor would output in torque is now provided by a motor half that diameter.  For the same physical size volume, the power output (speed X torque) has nearly doubled in that time.”

    Power on, robots. 

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