Navigation system improves knee replacement surgery

Christian Joly is confident about OMNIlife Science’s future.

“If you look at OMNI two years from now,” he says, “we’ll be the best robotic orthopedic company in the world.”

Over the phone, Joly’s enthusiasm is evident. Vice president of robotics and navigation, he lists steps the medical robotics company is taking to overcome its competition. OMNI is “investing heavily in robotics,” he says, while “increasing [its] research staff so [it] can keep innovation going.”

The strategy isn’t new to the East Taunton, Massachusetts, company. But, listening to Joly, it becomes clear that the company’s ultimate goals are still in their nascent stages, despite the success it has experienced so far. Much of the plan relies on building on its OMNI­NAV Surgical Navigation System.

The system, for total knee replacement (TKR) surgeries, uses a computer scanner and robotic guidance to offer surgeons more precision and accuracy during an operation. Currently, 23 hospitals have the system, but George Cipolletti, OMNI president, says that number could more than double by the end of 2015.
 

Two technologies

More than 4.7 million people live with prosthetic knees, according to the American Academy of Orthopaedic Surgeons (AAOS). Approximately 600,000 TKRs occur each year in the United States, but the AAOS expects the frequency to increase with the nation’s growing aging population.

Along with safety, precision and accuracy are the most important considerations during the operation. Until recently, a surgeon had to eyeball the procedure, using his best judgment to insert and align an implant.

The OMNI system changes that, thanks to its Bone Morphing technology and iBlock Cutting Guide.

The multi-patented Bone Morphing technology scans the patient’s knee, generating a 3D model of the femur and the tibia in the operating room. To generate a model, surgeons take a pointer linked to the computer and brush it over the bone. Joly says the process resembles an artist painting her canvas. The Bone Morphing technology uses algorithms to form its model.

Other navigation systems use pre-operative CT scans to create 3D models, but Joly says that strategy is imprecise. During an operation, the surgeon might see something the CT scan didn’t show, forcing him to improvise a new procedural plan.

“A CT scan doesn’t give you the entire representation of the knee,” Joly says. “The good thing with our technology is, what you see is what you get. There is no imprecision. You capture what the reality is.”

With information from the Bone Morphing technology, the computer suggests types of implants, position of the implant, and where to make incisions on the femur and the tibia.

From there, the surgeon attaches the iBlock Cutting Guide to a holder on the patient’s knee. The computer system then positions the cutting guide, and the surgeon uses it to insert the blade exactly, ensuring correct alignment of the knee implant. Joly says the guide performs the femoral cut with a precision of less than a millimeter.

The iBlock features a 5-axis system so it can accommodate several angles and degrees of cutting. Surgeons can see real-time assessments of limb alignment and soft tissue at any time during the procedure and make adjustments if necessary.

“[The system] can basically position the cutting guide at all kinds of different angles and fields for different types of pathology and different styles of implants,” he says. “At the same time, surgeons have the ability to control the surgical process, because they still have to control the blade, which is in control of the surgical process.

“If they don’t like a step in the surgical process, they have the ability to change it. There is a lot of control left in the surgeon’s hand.”
 

Manufacturing

OMNI handles the design and assembly of its robotic device internally. Joly explains the company has a “fantastic team of robotics [experts]” that knows the business and technical side of the market. After designing, experts select off-the-shelf electronic components.

Mechanical components, however, are manufactured by external vendors.

Although OMNI works with several companies, Joly can only discuss its partnership with New Zealand-based Enztec. Both businesses share the same parent company, Orthopaedic Synergy Inc.

Joly estimates that nearly two-thirds of the OMNINAV Surgical Navigation System’s components are manufactured at Enztec. He says the rest are distributed between manufacturers in the United States and France.

In-house, the company goes through quality and verification processes to make sure the system fits OMNI’s criteria and meets medical standards.
 

Looking ahead

Cipolletti says the navigation system benefits patients and clinicians. Because of the system’s accuracy, recovery times are significantly reduced. Some surgeons have performed same-day procedures. Its precise alignment enables patients to have more active lifestyles and ensures the implant will function for a longer period of time.

Joly focuses on how the system helps surgeons, saying it is less expensive than other navigational systems. He also says OMNI considers doctors more than just customers.

“We want the surgeons to be a partner with us. We don’t want them to be a true customer,” he says. “We want to help them. And therefore our business model is to provide them with all the tools to be better.”

Cipolletti, in an interview with Boston Magazine, elaborated on how the company plans to provide doctors with better tools. He said a total hip replacement navigation system could hit the market within the next year. The company is also considering expanding into partial knee replacements.

“We keep innovating, and we keep innovating,” Joly concludes. “We are going really beyond everybody else today.”

OMNIlife Science Inc.
www.omnils.com

About the author: Danny English is the associate editor of TMD and can be reached at denglish@gie.net or 216.393.0240.