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

The HSS Innovation Institute worked closely with Drs. Wolfe and Crisco to obtain a patent for their research and design ideas. The patent was then licensed to Extremity Medical, LLC, a privately funded medical device company in New Jersey.

“We believe the new wrist replacement, known as the KinematX™ Total Wrist Implant, has advantages over traditional implants,” said Dr. Wolfe, chief emeritus of the Hand and Upper Extremity Service at HSS. “Our extensive research into how the wrist moves helped us design a replacement that more closely matches the anatomy and motion of a normal wrist. This should allow for more natural motion and increased durability compared to currently available implants.”

“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 five million people in the United States. 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.

“Most people are familiar with total joint replacement in the knee or hip, which is much more common and highly successful,” said Dr. Wolfe. “Total wrist joint replacement has not enjoyed the same degree of success. Historically, some studies demonstrate failure rates of near 50% within 5 to 10 years, mainly due to loosening of implant components.”

Dr. Wolfe and his longtime colleague, Dr. Crisco set out to design a better wrist replacement 30 years ago. 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 based on their research.

Over the years, Drs. Wolfe, Crisco and colleagues have received more than $10 million in research grants from the National Institutes of Health to study the wrist. They have published hundreds of papers in peer-reviewed journals. In 2017, they received the Kappa Delta Award from the American Academy of Orthopaedic Surgeons and the Orthopaedic Research Society, considered one of the highest honors for an orthopedic researcher.

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. “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.

Wrist replacement surgery with the KinematX™ will be performed on an outpatient basis. Dr. Wolfe says he already has a waiting list of individuals who are good candidates. A patient registry will be established at HSS and other leading medical centers across the country to track data on outcomes.

Extremity Medical, LLC will be responsible for the manufacture and distribution of the KinematX™ Total Wrist Implant, which is expected to be available before the end of the year.

The scapholunate is a critical ligament that connects and stabilizes the scaphoid and lunate, two small bones near the center of the wrist. When an injury, often a fall on an outstretched hand, causes the ligament to rupture, patients can experience pain, lose grip strength and develop arthritis that gets worse as time goes on.

“When the ligament tears, the scaphoid and lunate bones will separate, start to rotate and degenerate. Some patients can feel the scaphoid popping in and out of its normal position,” Dr. Wolfe explains. Without treatment to repair the torn ligament, people ultimately develop a condition known as SLAC wrist. SLAC, which stands for “scapholunate advanced collapse,” is the most common form of post-traumatic arthritis in the wrist, affecting about four million people. As the bones rub abnormally against each other, their protective cartilage wears away.

“The injury most often affects healthy active people. When the ligament ruptures, any activity that combines wrist motion and wrist strength becomes difficult, if not impossible,” Dr. Wolfe says. “Affected patients report problems performing jobs that require manual work. They can no longer play sports such as golf or tennis, do yoga or Pilates, or work out with weights at the gym.”

Until now, surgery to reconstruct a torn scapholunate ligament has not been ideal, Dr. Wolfe says. The most common repair, which entails the use of metal wires and pins, fails in about 30 percent of patients.

In searching for a better treatment, Dr. Wolfe and his research team studied what happens in the wrist after the ligament tears in his laboratory. Once they identified the mechanism and involved ligaments, they presented and published their research in international forums and medical journals. Dr. Wolfe and his associates have received awards for their work. At the same time, Dr. Michael Sandow, a colleague of Dr. Wolfe’s in Australia, developed a 3-D computer model to study the way the wrist bones move and identify the injury mechanism from a different perspective. Dr. Sandow arrived at the same conclusion and developed a novel technique to address all components of the injury. He published a paper documenting the surgery and outcomes in 10 patients at two years following surgery in the European Journal of Hand Surgery.

Dr. Wolfe is one of just a few hand surgeons in the U.S. performing the new procedure, known as ANAFAB (anatomic front and back repair). “The goal is to reconnect the bones and restore their normal motion to provide pain relief, make the wrist stable again and stop the arthritic process,” he explains.

Dr. Wolfe describes the surgery as a complex and highly technical procedure. “The critical ligaments in the front and the back of the wrist are reconstructed by using a portion of one of the tendons in the patient’s wrist, combined with a synthetic tape that’s 10 times stronger than steel, weight for weight. The tape is very strong, but also very lightweight and very thin,” he says. “The patient’s own tendon and this synthetic material are woven through the bones in such a way that the scapholunate ligament, as well as two other nearby ligaments, are repaired all at once. This brings the bones back into the proper position and stabilizes them, so abnormal movement is stopped.”

The new procedure is performed without the use of wires and pins, a major advantage, he says, as metal hardware in the wrist can loosen, become infected, fail and necessitate another surgery.

Dr. Wolfe has performed the ANAFAB procedure on 14 patients to date and is monitoring their progress. So far, so good. Fifty-eight-year-old Peter Shrair, a business/commercial real estate attorney from Longmeadow, Massachusetts, is doing well after having the surgery. He has sent Dr. Wolfe videos of himself doing pull-ups in the gym.

Mr. Shrair originally hurt his left wrist in 2017 while doing an exercise called a "power-clean" with a barbell. A steroid injection shortly after the injury provided relief, but by April 2018, he started having wrist pain that worsened as time went on. That’s when he was diagnosed with the ligament tear. He bought wrist wraps so he could continue to work out, tried physical therapy and saw a prominent hand surgeon at a highly regarded hospital in Boston Massachusetts. “He told me there was nothing I could do,” Mr. Shrair recalls.

It got to the point where his wrist felt sore all the time. To make matters worse, he was left-handed, and it became increasingly difficult for him perform basic activities, such as using a knife to eat, carrying a heavy book or exercising with his left hand. Mr. Shrair knew about HSS and decided to go online and do his own research. He found Dr. Wolfe, made an appointment and did not hesitate when Dr. Wolfe told him about the new surgery. "Dr. Wolfe explained the procedure and recovery protocol to be sure I understood it and would follow it."

Mr. Shrair had the procedure in November 2018 and says he has no regrets. “I’m 100 percent, I’m really doing great,” he says. “Dr. Wolfe's explanation was accurate. I followed his protocol and had an outstanding result.” Mr. Shrair is now back to snow skiing, water skiing and working out at the gym.

Forty-year-old Asad Spahic, a mechanical engineer from Southington, Connecticut, also found Dr. Wolfe online. His ligament injury, sustained nine years earlier, had led to worsening wrist instability and weakness. He enjoyed participating in sports, but his wrist felt like it was giving way during certain activities, and he began to experience a dull ache. X-rays showed that arthritis was developing.

“A local doctor said the arthritis would get worse, the longer I waited to have surgery. I searched online for the best doctor I could find, reading medical journals,” Mr. Spahic said. He knew that once arthritis became severe, a wrist fusion was the standard procedure for pain relief, but a fusion would limit wrist motion and curtail his athletic activities.

He opted for the new surgery with Dr. Wolfe in May 2019. “My experience has been nothing short of phenomenal,” Mr. Spahic says. “I don’t even think about my wrist. I go skiing, I play soccer, although I use a wrist brace in case I fall because it’s been less than a year since my surgery. I have zero pain, zero problems, and the same strength as in my other wrist.“

Dr. Wolfe says he will continue to conduct follow-up to gauge the outcomes of ANAFAB surgery to see how patients fare over the long term. “The results are preliminary, but in my 30-year career I have not been this excited about this kind of ligament repair. We’re seeing patients who are now pain-free and back to activities they enjoy.”

The surgery was to repair a torn ligament.

Read the full article at JSOnline.com.