In November 2018, Medacta announced it had received clearance from the U.S. Food and Drug Administration (FDA) for the GMK® Sphere
– Kinematic Alignment instrumentation and surgical technique for total knee replacement (TKR). The manual instrumentation and technique are components of the new Kinematic Alignment Platform (MyKA)
offering, which is based on the kinematic alignment surgical approach, an alternative to traditional mechanical alignment for TKR that has demonstrated significant benefits for appropriate knee arthroplasty patients. This innovative individualized technique aims to restore normal knee function by resurfacing the femur and tibial articular surfaces to those of the normal or pre-arthritic individual state. A study published in the Bone and Joint Journal in 2014 by Dosset et al, demonstrated that this approach is aimed at achieving optimal patient satisfaction and function, while minimizing damage to the surrounding tissues and ligaments.
Since 2018, a rapid growth and adoption of the kinematic alignment technique has been reported worldwide. The Israeli orthopedic market has been well known for its fast adoption and development of new clinically valuable breakthroughs. Following a presentation in Israel by Dr. Stephen Howell, a renowned orthopedic surgeon and global pioneer of the technique, a fast-growing community of Israeli surgeons has started practicing and mastering the kinematic alignment technique.
The 2,000th case in Israel has been successfully performed by Dr. Yaron Bar Ziv, the director of the joint replacement unit at Shamir Medical Center and a leader of the technique in Israel.
"I am happy and proud that the kinematic alignment practice I am deeply dedicated and involved in has gained popularity. It has completely transformed my patient satisfaction and rehab. I see on a daily basis patients that are happier and who return to their normal life and activities much faster. This is a great improvement from my previous experience. I can't express deeply enough how we all should thank Dr. Howell for his braveness of standing up and in front during the last decade and for his lifetime commitment for developing this clinical game changer for the behalf of our patients worldwide" said Dr. Bar Ziv.
"Although the milestone of reaching our local 2,000 surgeries is important and re-assuring, we are even more excited to see the fast and wide adoption of this method of surgery in Israel. Studies and patient outcomes are starting to create awareness that kinematic alignment may offer benefits for appropriate knee arthroplasty patients. I am very happy to be one of the local Israeli surgeons that are practicing and focusing on individualized and personalized level of arthroplasty surgery and proud to be able to execute this philosophy to all my patients.” concluded Dr Bar Ziv.
Kinematic alignment is a surgical approach that is rapidly growing, as expressed by Mr. Eyal Pais, Co-CEO of Bepex Ltd – the exclusive distributer of Medacta International in Israel: “We believe that Israel is a microcosm and a good filter for innovations and I can proudly say that kinematic alignment is an excellent example of how a simple and intuitive technique can bring a new light and positively change patient outcomes. Today we estimate that in Israel itself more than 25% of knee replacements are done through the kinematic alignment approach and strongly believe that the percentage of utilization will further rapidly grow as more and more scientific evidence is coming out and more and more surgeons are seeing and hearing their peers’ clinical results. The fast-growing community of my national and international colleagues that are adopting the approach is encouraging and will enable us to better focus as a group.”
In line with Medacta’s belief that “Innovation requires education”, the support of the M.O.R.E. (Medacta Orthopaedic Research and Education) Institute has proved fundamental, as Francesco Siccardi, CEO of Medacta points out: "I am truly happy and enthusiastic for what Medacta has been able to set up, creating a network of expert surgeons to support this technique with the precious support of the M.O.R.E Institute, our global education platform. With the Israeli milestone achievement and the rapid adoption worldwide, I am reassured that the offer of MyKA coupled with the GMK Sphere will contribute much to this field and reinforce our commitment to personalized medicine and minimally invasive techniques”.