HSS Hand Surgeon Performs First Surgery with FDA-Cleared Wrist Replacement Implant He Designed
Sixty-nine-year-old Mark Eisen says he waited seven years for a surgery he hopes will change his life. Last week, he had the first total wrist replacement with KinematX™, a new implant co-designed by Scott W. Wolfe, MD, chief emeritus of the Hand and Upper Extremity Service at Hospital for Special Surgery (HSS). Dr. Wolfe performed the surgery on April 15.
Severe arthritis in his right wrist caused ongoing pain and prevented Mr. Eisen, who lives in Atlanta, from engaging in activities he enjoys. He is right-handed, which makes it even more difficult. Seven years ago, he started to investigate treatments and learned about total wrist replacement surgery. But unlike knee and hip replacements, which are common and have excellent outcomes, wrist replacement surgery has not enjoyed the same degree of success.
Mr. Eisen’s online research prompted him to take his first trip to New York for a consultation with Dr. Wolfe in 2014. Mr. Eisen had read about Dr. Wolfe’s extensive research into how the wrist moves and learned that he and his long-time colleague and co-inventor, Joseph J. (Trey) Crisco, III, Ph.D., Director of Bioengineering at the Warren Alpert Medical School, Brown University and Rhode Island Hospital, were working on designing a new, more durable wrist replacement. Mr. Eisen has been following their progress for the past seven years.
Last year, the KinematX™ Total Wrist Arthroplasty System, which is manufactured by Extremity Medical, LLC, received 510(k) clearance from the US Food and Drug Administration (FDA). The design is the culmination of three decades of award-winning research by Dr. Wolfe and Dr. Crisco. Over the years, they and their colleagues have received more than $10 million in research grants from the National Institutes of Health to study the wrist.
Mr. Eisen is looking forward to regaining the use of his wrist. “It had become more painful over the years, with the pain often radiating up to my forearm,” he explains. “My wrist movement was severely restricted, making it difficult to do anything that required me to bend my wrist. Everyday activities like cooking, working around the house or picking up a pot of coffee with my right hand were difficult and painful.”
Dr. Wolfe believes the KinematX™ has advantages over traditional implants. “Our extensive research into how the wrist moves helped us design a device that more closely matches the anatomy and motion of a normal wrist,” he explains. “This should allow for more natural movement and increased durability compared to currently available implants. Some studies report failure rates of 50% within 5 to 10 years, mainly due to loosening of the implant components.”
“In our view, the KinematX™ will be a game changer in the field of wrist replacement surgery,” said Doug Leach, managing director of Biomechanical Innovation at the HSS Innovation Institute. “Current wrist replacement devices are relatively dated. The new implant design leverages the clinical and bioengineering experience of Drs. Wolfe and Crisco, their seminal research, and modern-day engineering and design principals of total joint replacement in general.”
Wrist arthritis is one of the most common and debilitating conditions treated by hand surgeons, affecting about 5 million people in the United States, according to Dr. Wolfe. A fusion of the wrist bones can alleviate pain, but patients are often limited in performing some activities. Wrist joint replacement surgery was proposed five decades ago as an option to relieve pain and restore function.
When Drs. Wolfe and Crisco set out to design a better wrist replacement, the first step was to unravel the complexity of how individual bones move in a normal wrist and in one that has sustained an injury. Their research led to the design and validation of a noninvasive three-dimensional motion analysis system to measure wrist kinematics, which describes the wrist motions necessary for a wide range of activities. Armed with that information, they sat down at Dr. Wolfe’s kitchen table and started sketching out their idea for a novel wrist replacement.
The wrist is highly complex, made up of more than a dozen individual joints formed by eight small bones that collectively make up the wrist. It was previously believed that the wrist moved the hand in two different planes – up and down or side to side. The research by Drs. Wolfe and Crisco demonstrated that during many activities, such as throwing a ball, hammering a nail or pouring a glass of water, the wrist doesn’t move in just one of these directions. It accomplishes the action by combining movements in both planes.
“Traditional wrist replacements often constrain the wrist to move in one plane at a time, and this puts stress on surrounding joints," said Dr. Wolfe. “The increased loads on the implant-bone interface often lead to prosthesis loosening and mechanical failure. In addition, traditional implants often make it difficult or impossible to return to some activities, such as tennis or golf.”
The KinematX™ is the only wrist replacement that is computer-designed to mimic the kinematics, or motion, of a human wrist – movements that are instrumental in throwing, hammering and other high-performance activities, according to Dr. Wolfe. The unique design should enable the implant to be more durable than traditional wrist replacements.
Surgery with the KinematX™ entails replacing the proximal carpal row bones of the wrist, which are those most severely affected by osteoarthritis. The device utilizes modular components in various sizes to replicate the complex anatomy of the wrist and allow the motion necessary for occupational, recreational and household activities.
The Innovation Institute at HSS played a key role in the development of the new wrist replacement, working closely with Drs. Wolfe and Crisco to obtain a patent for their research and design ideas. The patent for the wrist replacement was licensed to Extremity Medical, LLC, a privately funded medical device company in New Jersey.
“Our goal is to work with talented HSS physicians, inventors and entrepreneurs to empower them to develop innovations in musculoskeletal health that could improve or even revolutionize patient care,” Mr. Leach said.
A patient registry will be established at HSS and other leading medical centers across the country to track data on outcomes. Mr. Eisen says he will gladly report his progress. After recovery, he looks forward to going back to playing golf, fishing, working around the house and waxing his car.
To see a video of Dr. Wolfe discussing the new wrist replacement, visit: https://www.youtube.com/watch?v=BWgd-NtW5PI
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 13th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2022-2023), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2022-2023). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a third consecutive year (2023). Founded in 1863, the Hospital has the lowest complication and readmission rates in the nation for orthopedics, and among the lowest infection rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 145 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.