A team of researchers from Scripps Health has received a grant of $317,000 from the National Institutes of Health (NIH) to create what the development hopes is the world’s first smart shoulder replacement implant—one that can continuously and remotely monitor and transmit detailed data from patients’ new shoulders.
According to NIH, more than 800,000 U.S. patients had had total shoulder replacements (2017 data) and those numbers are expected to grow by over 200% by 2025, outpacing both hip and knee arthroplasty.1
The NIH’s $317,000 will be used to pay for the initial phase of research, which is expected to last two years at the Shiley Center for Orthopaedic Research and Education at Scripps Clinic on Torrey Pines Mesa. During this development phase, the team will work on design and produce and test the functionality of a smart implant prototype. They also aim to demonstrate proof of concept by testing the device in the shoulder of a human cadaver to validate the implant’s operability and consistency.
“Shoulder replacement surgery represents an important area of study,” said Darryl D’Lima, M.D., Ph.D., director of orthopedic research at Scripps Health and the initiative’s co-lead investigator, along with Heinz Hoenecke, M.D., an orthopedic surgeon and researcher at Scripps Clinic.
“Studies show that the number of these procedures has grown significantly in recent years in the United States and the trend is expected to continue. We need to gather and review data to better understand ways we can improve shoulder prosthetics and rehab approaches for patients, and this grant funding is an important first step toward that goal.”
Making a Smart Implant
The Shiley’s team intends to improve an existing shoulder implant by equipping it with customized wireless technology, such as advanced sensors and capabilities for data storage, external communication and rechargeable power.
In addition to being a functional shoulder joint replacement, it is also a research tool that can continually record and transmit data, such as mechanical forces, temperature, range of motion, and other metrics. The team cautions that actual surgical implantation of the smart shoulder device in a living patient is likely still a few years away.
Once the device is implanted, researchers and surgeons can collect and analyze data which could reveal new ways to enhance physical therapy protocols for shoulder replacement patients, as well as to improve the design of future implant devices.
Asked what challenges they anticipate with regard to design, production and functionality verification, Dr. D’Lima told OTW, “We need to modify a traditional implant to house the sensors and electronics. These have to be miniaturized to fit within the very small space. We also need to develop wireless rechargeable medical grade batteries and implement remote communications. All of these have to be tested to survive within a patient’s arm for 20 years or more.”
When OTW asked researchers how they will know if they’re on the right track after a year, Dr. D’Lima said, “We hope to meet all the design specifications, such as, sensor performance and accuracy, power requirements, data storage and retrieval, and telemetry communications. The proof of concept will be demonstrating full functionality after implantation in a human shoulder cadaver specimen.”
Also working with the Shiley Center team are Scott Delp, Ph.D., the James H. Clark professor at the schools of engineering and medicine at Stanford University, Scott Banks, Ph.D., professor and director of the orthopedic biomechanics laboratory at the University of Florida, and B.J. Fregly, Ph.D., professor at the department of mechanical engineering at Rice University and a scholar in cancer research with the Cancer Prevention and Research Institute of Texas. This team has experience collaborating with Scripps on collecting, processing and analyzing data on Scripps’ smart knee implant.
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