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New and novel enabling technologies are already providing a glimpse into what’s coming next in the high-tech world of orthopedic surgery.
Perhaps no other innovation has the potential to revolutionize the future of patient care more than smart implants, which are in the process of collecting reams of data that will someday improve device development in important ways.
Smart implants are still relatively fresh to the orthopedic space — Zimmer Biomet’s Persona IQ, the first-ever FDA-cleared smart knee implant, is less than three years old — so ongoing use will yield better results about how well they work and areas of needed improvement.
In its short life, Persona IQ has demonstrated the ways that monitoring patients during recoveries and collecting kinematic data metrics can improve care models during and after surgery. It also provided one of the first looks at how patient monitoring and treatment can have a positive impact on patient recovery.
Since Persona IQ hit the scene, the orthopedic industry has seen increased development of different smart technologies that are applying the concepts of smarter and more connective ecosystems into broader realms of treatment.
Jim Lancaster, President of Recon and Global Headquarters Executive Director at Zimmer Biomet, sees this as a boon to the industry.
“Adoption of smart technologies will continue to grow as more data is collected and surgeons and patients become more comfortable with the concept of data-driven care,” he said. “The key opportunity for industry lies in exploring how to better integrate implant systems and smart technology to ensure they both offer genuine clinical value.”
Widespread Applications
Promising improvements are occurring in the design of device sensors, actuators and communication systems that enhance the overall functionality of smart devices. For starters, smart implants help monitor the progress of patients’ post-op recoveries by providing real-time feedback to healthcare providers. The technology also collects secure data that will lead to the development of even more effective orthopedic devices.
“Smart implants offer unique opportunities for product development,” Lancaster said. “We can modify the hardware to ease the implementation process or minimize compromise in connecting the smart components to current implant constructs.”
Persona IQ includes sensors that measure force and motion in the knee. The data that’s collected is used to monitor a patient’s movement patterns and assess the implant’s overall performance.
“Surgeons and other care team members are now able to see how a specific patient compares with a similar cohort of patients as they recover,” Lancaster explained. “Additionally, ongoing development continues to explore the data to help determine causes of postoperative recovery complications associated with knee arthroplasty.”
This collection of real-time data points can enhance personalized post-op rehab programs. It can also optimize future implant designs. Lancaster believes that Zimmer Biomet will be able to create incrementally advanced software features as the volume of patient-specific kinematic data collected by Persona IQ increases.
Smart implants used in the treatment of fractures could be equipped with sensors to monitor the healing process. They could also detect bone density, strain and temperature to enhance treatment plans. To that end, scientists and engineers at The Technology Partnership (TTP) have developed a smart surgical nail that promotes fracture healing and tracks how well patients are progressing through recovery.
The smart nail features sensing functionality that doesn’t impact the mechanisms of the implant and is made from titanium that provides strength and support as the bone heals around it. Its sensing components are housed inside the titanium structure to avoid interactions with the body. Its design fits into the movement toward data-driven, personalized care.
“The device provides real-time feedback that allows orthopedic surgeons to adjust treatments based on the status of individual patients instead of standardized protocols,” said Simon Calcutt, an electronic engineer and consultant for TTP.
Smart spinal fusion cages that are in development use sensors to monitor spinal alignment, range of motion and force loads. The sensors inform intraoperative decision-making and guide long-term treatment plans for individual patients.
Last October, NanoHive Medical and DirectSync Surgical finalized a collaborative deal to develop a stimulating/sensing 3D-printed fusion cage that employs integrated patient-powered stimulators to enhance bone growth and provide surgeons with a post-op data analysis tool. The companies want to generate objective data insights to enable improved patient outcomes and reduce costs to the healthcare system.
Researchers at iSMaRT Lab have developed multifunctional mechanical metamaterials that function as sensors to record and relay valuable information about the pressure and stresses on its structure. Contact-electrification occurs when pressure occurs between the device’s conductive and dielectric microlayers to create an electric charge that relays information about the condition of the material matrix.
“Smart implants can provide real-time biofeedback and offer many therapeutic and diagnostic benefits,” said Amir Alavi, Ph.D., Assistant Professor of Civil and Environmental Engineering and head of iSMaRT Lab, which is affiliated with the University of Pittsburgh. “But it is incredibly challenging to integrate bulky circuits or power sources into the small area of implants. The solution is to use the implant matrix as an active sensing and energy-harvesting medium. That’s what we’re focused on.”
Dr. Alavi’s team incorporated the material matrix technology into experimental spinal cages designed for use during fusion surgery. “Fusion cages are usually made of titanium or PEEK polymer materials with certain mechanical properties,” Dr. Alavi said. “The stiffness of our metamaterial interbody cages can be readily tuned and the implant can be 3D-printed based on the patient’s specific anatomy before surgery, making it a much more natural fit.”
Because it is tunable and scalable, the device’s material could be adapted to other surgical applications, including implant components for hip and knee replacement. Dr. Alavi recently received a $557,000 Trailblazer R21 Award from the National Institute of Health, which will allow him to test his lab’s spinal fusion cages on animals. The team is also leveraging generative AI tools to accelerate its exploration of the medical design space.
“This technology leverages advances in nanogenerators and metamaterial to build multifunctionality into the fabric of implants,” Dr. Alavi said. “It’s clinically significant because surgeons can use the data generated by the implants to assess bone healing progress. This technological advancement is going to play a major part in the future of implantable devices.”
Transformative Care
Smart implants are contributing to improved surgical outcomes and advanced personalized care by monitoring patients outside of healthcare facilities and collecting quality data.
“The devices can be equipped with sensors, microprocessors and other electronic components that allow them to perform a variety of functions,” Lancaster explained. “After surgery, these devices are used to continually monitor patients’ conditions and the data are made available to the care team. This could reduce the need for comprehensive follow-up care and has the potential to reduce the economic burden on the healthcare system.”
Lancaster said that smart implants enhance the personalized care model surgeons strive to achieve because they collect ongoing data long after surgery.
“The technology can be used to monitor a patient’s range of motion, steps, gait speed and other metrics that help to ensure they are recovering as quickly and effectively as possible from joint replacement surgery,” Lancaster said. “Providers can use this information to make necessary adjustments to post-op treatment plans. It can also guide physical therapy and other rehabilitation efforts.”
Increased patient connectivity is already proving to be an important and effective way for patients to engage in efforts to improve surgical outcomes in demonstrative ways.
“Smart implants help on this front by allowing patients to be more involved in their care,” Lancaster said. “With personalized data readily available, patients can self-manage the recovery process by monitoring their progress. The data feedback loop could help them set, track and achieve incremental rehab goals.”
The data collected through smart technologies will help direct tomorrow’s surgical plans based on what’s learned from today’s surgeries. Lancaster is confident that the adoption of smart implants will lead to the development of unique algorithms that will have a positive impact on the care patients receive.
Patient privacy is a big point of debate surrounding the use of smart technology. Developers of smart technology must ensure safeguards are in place that allow surgeons to monitor patients without data being used nefariously. In many cases, this has required the addition of integrated data protection systems that protect the clinical information collected from patients.
“Ensuring patient privacy is crucial,” Lancaster explained. “There have never been more opportunities to use information collected during treatment to create innovative solutions to improve patient outcomes. At the same time, the importance of protecting the information has never been higher.”
Acceptance and Adoption
How will smart technology impact future advancements in orthopedic care? A lot will depend on surgeon feedback and industry goals.
Orthopedic companies are already empowering surgeons with data aggregation and visualization, artificial intelligence (AI) and precision robotics to remove the guesswork from procedures and strive toward improved, consistent and reproducible results. Lancaster predicts that emerging smart technologies will transform joint replacement care as an increasing number of cases shift from inpatient settings to hospital outpatient departments and ASCs.
A big part of this evolution will hinge on AI, which is already revolutionizing surgical decision-making by providing surgeons with powerful tools that help them understand a patient’s unique joint motion and predict outcomes based on intraoperative implant positioning.
Lancaster pointed out that AI algorithms can process vast amounts of surgical data, including patient records, imaging scans, implant design, patient-reported outcomes measures, patients’ pre- and post-op activity and real-time intraoperative data to assist in surgical planning, diagnosis and care management.
“Predictive models can personalize implant selection and alignment based on a patient’s characteristics and joint function goals,” he said.
Capitalizing on the potential of smart implants will demand that surgeons and patients get on board with the technology and all that it entails. “The industry needs to exercise caution with smart technology — not everything should be treated as if it were a problem to be solved with the same solution,” Lancaster said. “Our focus is on enhancing the seamless integration of implant systems and smart solutions.”
The adoption of smart technology in orthopedics will be gradual but inevitable.
“Think about the evolution of consumer technology,” Lancaster said. Millions of people adopted the Apple Watch because they had an iPhone, which they bought because they had an iPad. Technological advancements in our field will require multiple iterations like that before we can look back and comprehend how everything fits together cohesively.”
