Advancing the Art and Science of Knee Replacements

When a global medical technology leader went looking for orthopedic surgeons to help test new instruments and surgical techniques for one of its knee replacement systems, Harry Schmaltz, MD, with Lehigh Valley Orthopedic Institute, was on its short list.

In the multibillion-dollar joint replacement industry, a company needs to make sure what its engineers design works as intended in the operating room. It needs to make sure its procedures are clear and easy to understand in real-world conditions. It’s critical for approval from regulators and success in patients. “You need both sides of the equation to get any device to work well,” Schmaltz says.

LVHN is not identifying the medical technology company in this article because of the pending Food and Drug Administration (FDA) application process.

Schmaltz, who performs surgery at the newly opened Lehigh Valley Hospital–Dickson City, has been involved with similar testing in the past, but says it’s not common because of the huge cost of developing a new product and getting regulatory approval.

He says he was thrilled to participate because it’s important to keep advancing the craft of orthopedic surgery. “It’s incumbent on the surgeons of the world and on the industry,” he says. “We need to drive the value equation and we need to make this more successful and, if at all possible, we need to do it less expensively along with making it better.”

Schmaltz’s participation is a plus for Lehigh Valley Orthopedic Institute, launched earlier this year. “We’re not just good guys doing good surgery and taking care of patients. We’re on the forefront of advancing the art and science of knee replacement surgery,” Schmaltz says.

Schmaltz, with Coordinated Health Scranton Orthopedics, traveled to the company’s U.S. research headquarters in April, joining five other orthopedic surgeons from across the country also tapped to test the new instruments and surgical technique. Those surgeons hailed from institutions such as Johns Hopkins and Stanford.

Schmaltz and the others were there to assist with an FDA requirement regarding the instruments and surgical technique for the new knee-system. “The way you prepare the bone for this new system is a little bit different, so the instruments you use to prepare the bone are new,” Schmaltz says. “To get FDA approval, you have to validate that the instruments work and the surgical technique works and is understandable.”

To do that, Schmaltz and others performed knee replacements on cadavers, using cemented and cementless methods. Schmaltz, who believes the long-term future favors cementless implants, says the company’s system will use the same instruments, regardless of whether the surgeon uses cement. That differs from how things are currently done, he says.

Schmaltz and the other surgeons had to assemble the new instruments on their own and could not ask questions while performing the implants using the company’s new technique. Surgeons provided feedback after the procedures were completed. “It validates the instructions are written clearly and the instruments are easy to use and prepare the bone as designed,” he says.