Despite their many years of training and experience, orthopedic surgeons up to now could not count on precise data about the alignment and balance of knee replacements.
“We developed the knee balancer to deal with the unmet need of avoiding and reducing implant failure, which can be caused by misalignment or infection,” OrthoSensor’s CEO said. The cost of revisions — or redoing knee and hip implants — will reach an estimated $8.6 billion by 2015, Pierce added, and each revision normally costs more than the original operation. About seven percent of all knee replacements need revisions each year, he said, and 35 percent of all implant failures occur within two years of the original operation.
“We are very much focused on improving clinical outcomes and reducing costs,” said Pierce, whose company has grown to about 30 employees.
Roche, who holds multiple patent applications and has served as a consultant to DePuy Orthopedics and the Florida Marlins, so far has done more than 250 knee replacements with the OrthoSensor Knee Balancer and is educating other surgeons on its use.
Dr. Alejandro Gonzalez Della Valle, an orthopedic surgeon based in New York City, has been using the OrthoSensor Knee Balancer for the last several months. “OrthoSensor is doing something orthopedic surgeons have needed for a long time,” said Gonzalez Della Valle, who is associate attending orthopedic surgeon at the Hospital for Special Surgery in New York City.
“This device gives a very accurate measurement that corresponds to the pressure of the ligaments. You get the information in real time,” he added. “It makes knee surgery much more precise and it helped me be a better surgeon.”
Gregory J. Golladay, M.D., an orthopedic surgeon who specializes in minimally-invasive knee replacement and hip replacement at the Orthopaedic Associates of Michigan in Grand Rapids, has been using the OrthoSensor Knee Balancer since the first quarter of this year. “Many patients say that the new knee feels normal, and prior to OrthoSensor this was not unheard of, but was unusual,” he said.
Orthopedic surgeons will do about 660,000 knee replacements this year in the U.S., and one-sixth will be revisions, added Golladay, who was a consultant to OrthoSensor and helped develop the device. The results of the current trials using the OrthoSensor could show that it plays an important role in reducing the need for revisions.
Aside from the knee balancer, OrthoSensor is also working on other devices to provide physicians with real-time data on implants during and after operations. Scheduled for launch in 2013 are new OrthoSensor devices for knee alignment and hip positioning surgeries. Implants that can monitor load, range of motion, and loosening are projected to be available in late 2014.
Using microelectronics and the latest technology, other implants under development will be able to provide data on infection, pain and bone density. Batteries in these implantable devices are designed to last 20 years.
Roche, who for many years was interested in using sensors and technology for surgery and patient care, worked with Fort Lauderdale-based Mako Surgical Corp. in 2005-2006 to help develop its RIO Robot arm for orthopedic surgery. He later met with engineers from Medtronic, a medical technology company, to discuss how sensors he had acquired in Israel might be used in medicine.
Roche and one of the engineers, Marc Stein, now chief technology officer at OrthoSensor, began collaborating. Roche subsequently met Pierce, then the CEO of Visible Assets, a company that made radio frequency identification tags for patients, and the three decided to work together at OrthoSensor.
“I always was interested in advanced technology, saw a medical need and was able to put the best team together,” Roche said. “With Baby Boomers aging, we’re expecting more knee replacements, and we will be expanding to other joints.”