Florida Surgeon Helps Develop Single-Use Knee Replacement System Designed To Reduce Contamination Opportunities

Most patients undergoing knee replacement surgery never see the multiple large metal trays, weighing upwards of 80 pounds, typically required for the procedure. In traditional orthopedic surgery, these instruments are repeatedly cleaned, sterilized, wrapped in blue sterile wrap, transported, stored, opened, and reassembled between surgeries. They are often used over hundreds or even thousands of procedures. While the process has long been standard throughout healthcare, it is also labor intensive and highly dependent on sterile processing departments responsible for preparing and maintaining large reusable instrument systems. Even small holes or defects in sterile wrap can occasionally create concerns within hospitals and surgery centers, sometimes contributing to delays or cancellations if discovered before surgery. Missing instruments, damaged trays, and sterilization-related workflow issues are also well-known operational challenges within busy surgical environments.

A newly FDA-cleared technology called SteriKnee is attempting to take a very different approach. Developed by NovoSource, an orthopedic company headquartered in Morgantown, West Virginia, the system is designed as a sterile, preassembled, single-use knee replacement instrument platform. SteriKnee is intended for one patient and one procedure. Rather than relying on traditional reusable trays, the instrumentation arrives procedure-ready before surgery.

Dr. Jesse Shaw, an Orthopedic Surgeon with All-Pro Orthopedics and Sports Medicine in Pembroke Pines, Florida, who participated in the development of the SteriKnee system, believes patients are becoming increasingly interested in technologies designed to reduce opportunities for contamination and improve confidence in the surgical environment.

“Infection remains one of the most serious complications in joint replacement surgery,” Shaw said. “While no technology can eliminate infection risk entirely, reducing the number of steps, touchpoints, and opportunities for contamination is a worthwhile objective for both surgeons and patients.

“Traditional instrument systems may undergo extensive reprocessing and preparation before ever reaching the operating room. SteriKnee was designed around a different philosophy. The instrumentation arrives sterile, preassembled, and prepared specifically for one patient and one procedure.

“Patients place tremendous trust in their surgical team. We have a responsibility to evaluate technologies that may help simplify processes and reduce potential sources of contamination wherever possible. The challenge is not limited to surgery centers. Hospitals perform hundreds of thousands of knee replacements every year and face many of the same sterilization, handling, and preparation challenges.”

Traditional orthopedic instrument systems contain nearly a hundred or more components that must be cleaned, inspected, assembled, wrapped, sterilized, transported, stored, and reopened before surgery. Although each step is carefully controlled, the process still introduces additional handling and complexity. Supporters of sterile single-use instrumentation believe reducing those steps may help create a more predictable surgical environment while reducing potential opportunities for contamination.

While SteriKnee was designed with the growing outpatient market in mind, the system can also be used in traditional hospital settings. With nearly one million knee replacement procedures performed annually in the United States, supporters believe technologies that simplify surgical preparation, reduce instrument reprocessing requirements, and lessen demands on sterile processing departments may become increasingly important across the healthcare system.

Doug Hawkins, Founder of NovoSource and a longtime orthopedic industry entrepreneur, believes patients are beginning to pay closer attention to how surgical procedures are prepared and performed.

“Patients today are more informed than ever before,” Hawkins said. “Many are surprised to learn what goes on behind the scenes with the preparation of traditional orthopedic instrumentation between procedures. When given the choice, I believe many patients would prefer instrumentation prepared specifically for them rather than instruments that have been repeatedly used, reprocessed, and handled over many years. That philosophy is what inspired SteriKnee.”

NovoSource plans to begin limited rollout procedures with select surgeons and outpatient surgery centers later this year. The company’s NovoKnee implant platform, used in conjunction with SteriKnee, has already been utilized in thousands of knee replacement procedures.

As outpatient joint replacement continues to expand nationwide, NovoSource believes technologies focused on sterility, efficiency, and simplified surgical preparation may play an increasingly important role in the future of orthopedic care.