Orthogrid Systems Inc., of Salt Lake City, has received a green light from the U.S. FDA for the latest application on its intraoperable PhantomMSK platform, this one for use in orthopedic trauma cases. The new PhantomMSK Trauma application, which Orthogrid plans to formally roll out next spring, joins currently available applications for total hip and hip preservation.

The Trauma application is an orthopedic surgical software that can be used universally in most orthopedic trauma procedures, Edouard Saget, co-founder and co-CEO of Orthogrid, told BioWorld MedTech via email. It helps surgeons achieve and confirm the alignment of bone fractures and improves intraoperative efficiency via artificial intelligence-trained and augmented reality-based decision support and assistance for the placement of surgical instruments.

This first version of PhantomMSK Trauma (MSK stands for muscular skeletal) aims to help surgeons navigate all the major steps in an orthopedic trauma procedure, Saget said. “In most, if not all trauma procedures, about two-thirds of the time is spent aligning bone fragments … so as to restore anatomical alignment before moving on to the fixation part,” he explained. “Our universal Trauma solution is unique as it focuses solely on the alignment and temporary fixation. It is a first in the market.”

Correcting image distortion

Orthopedic trauma procedures rely heavily on fluoroscopic images – intraoperative images produced by a c-arm – to guide anatomic alignment, but these are susceptible to image distortion from external electromagnetic interference and other factors. “Our internal studies show a wide range of distortion at any given time in operating rooms,” Saget said. “It is not perceivable with the naked eye, and surgeons have to take careful steps to double check against other references they can trust. It is time-consuming if they do it right.”

According to Saget, data on total hip replacements show that failure to correct for distortion can result in leg length being off by almost an inch. The problem is the second most common cause of orthopedic-related medical malpractice claims, after nerve damage.

Orthogrid’s PhantomMSK “platform-as-a-service” technology – which works with all medical devices across different procedures – corrects the distortion and processes the new image against an organized workflow specific to a certain type of procedure. In the case of trauma, digital tools are available throughout the surgical workflow to aid in image analysis and completing the procedure.

Saget said the AI algorithms it uses are trained and tested for specific tasks, such as recognizing certain anatomical features or instruments, and updated regularly to enhance efficiency.

Tool reflects 30 years of data

In developing the Trauma application, Orthogrid reviewed 30 years of literature and data about surgical precision needs and their impact on patient outcomes. The company then tested its solution, based on these requirements, for accuracy and efficacy. “We are now looking forward to working with physicians who are interested in pursuing further clinical studies around short-, mid- and long-term outcomes, now that we have [FDA] clearance,” Saget said.

Orthogrid’s first PhantomMSK application, for total hip, got the FDA’s nod as a class I device in March 2018. The tool was primarily used in anterior total hip replacements. A more advanced version of the total hip replacement application received 510(k) clearance in February of this year. The class I hip preservation application was released in June.

With FDA clearance of total hip, hip preservation and now orthopedic trauma applications in hand, Orthogrid is looking to other indications for its PhantomMSK platform. Currently in the pipeline are spine and pain management, both in preliminary stages, Saget noted. “Anywhere a fluoroscopic image is used, we always find a step that could be supporting a surgeon’s decision.”

Expanding pipeline

Founded in 2012, privately held Orthogrid also produces Hipgrid, an advanced fluoroscopic grid technology designed to improve decisionmaking during total hip replacement surgery, and the next-generation Hipgrid Nine. Like PhantomMSK, they interface with existing hospital equipment and implant systems. In addition to the U.S., where PhantomMSK is seeing good uptake, the platform is approved for marketing in Australia and “gaining momentum there,” Saget said. The company expects the trauma application could see strong sales in centers that train medical residents and fellows.

While no other companies offer the same intraoperative alignment advantage, according to Orthogrid, it does have competitors. Among them are Orthoalign Inc., of Aliso Viejo, Calif., which offers inertial navigation systems for joint replacement surgery, and Paris-based Eos Imaging SA, which has a 3D imaging system for orthopedic procedures.

As for Orthogrid’s business strategy, the emphasis is on growth and R&D. “We are … maintaining our focus on building our technology platform and the architecture around it, which will soon support other efforts around patient engagement as hospitals and surgeons look to compete for patient attention and seek increased volume,” he said.