Augmented Reality Applications Gain Traction in Orthopedics

Augmented reality (AR) has proven to be applicable to a variety of industries and use cases over the years. What started as a military technology two decades ago has been leveraged in everything from video games to orthopedic surgeries.

The technology differs from virtual reality in that it uses the real-life physical space you are in and adds a 3-dimensional layer of tech-enabled visualization on top of it. Virtual reality, on the other hand, is a completely virtual space with a fake environment.

AR provides endless opportunities for orthopedic surgeons in the education space, pre-operative planning, live surgery and many other scenarios.

“It gives us, essentially, x-ray vision. It’s like being one of those superheroes in cartoons of old,” said Stefano Bini, M.D., University of California San Francisco. “One of the interesting things about this technology is that because it is visual, it’s actually very readily accessed.”

With the evolution of orthopedic technology from x-rays to navigation and robotics to 3D modeling, a surgeon’s ability to visualize the problem and find the right solution has benefited from incremental improvements over previous technologies.

“[With AR] you can now know exactly what the hip replacement needs to look like before you even start the procedure,” said Jonathan M. Vigdorchik, M.D., Hospital for Special Surgery. “It’s not only helpful for the complex cases, it’s also helpful for the routine cases in terms of ease of use and efficiency.”

While AR gives surgeons a powerful tool for real time assessment and navigation, it also is a time-saver and reduces variability, taking out a lot of the guesswork and exploration during a live surgery.

“The promise of this technology is that when you know and you can see what you’re going to do before you do it; there aren’t those steps that are so exploratory during surgery,” Dr. Bini said. “It just saves so much time.”

Drs. Bini and Vigdorchik spoke about AR and the intersection of technology and cost of care at the Interdisciplinary Conference on Orthopedic Value-Based Care. The conversation led us to look into the recent technology announcements in the space. While AR is still a niche technology in orthopedics, it is gaining ground. We’ve tracked six product announcements in the last year, outlined below. These technologies span joint replacement and spine applications.

Pixee medical Knee+

Pixee Medical Knee+ navigation system

Pixee Medical

Pixee Medical received CE Mark approval and FDA 510(k) clearance for Knee+, the first orthopedic navigation system to employ AR for total knee replacement. It has been commercialized in Europe and Australia and the U.S.

Knee+ patented technology combines proprietary computer vision and deep learning algorithms, and can be used with off-the-shelf AR glasses to track instruments and implants during a procedure. The navigation software installed in smart glasses is combined with reduced-size MIS instrumentation equipped with markers that can be sterilized in an autoclave. Sizing and ligament balance functions can be quickly integrated into the product.

Augmedics

Augmedics introduced xvision in June 2020. At its core, xvision is a wireless headset that allows surgeons to see 3D visualization of the spine directly on the patient, alongside 2D axial and sagittal views, giving surgeons the ability to accurately guide instruments and implants during procedures.

When the system is in use, the patient has a registration marker rigidly attached to his spine. The xvision software determines where the anatomy is in relation to the registration marker, and the information is transferred wirelessly to the headset. A transparent display attached to the headset will project the 3D anatomical and instrument detail for the surgeon without obstructing the operative field. The customized headset contains a high-speed processor, headlight, built-in surgical tracking system and optical transparent display lenses that project images directly onto a surgeon’s retina. Compatible with all intraoperative 3D scanners, the wireless system is O.R.-ready with a two-minute setup.

Augmedics received FDA clearance for the xvision spine system in 2019, and is now selling the systems in the U.S.

Medacta

In July 2020, Medacta received FDA clearance to market its NextAR™ AR-based surgical platform for total knee arthroplasty (TKA). NextAR TKA, which works with the Medacta GMK Sphere Medially Stabilized Knee, is the first application of a new platform technology that will be extended to hip, shoulder and spine, and is designed with Artificial Intelligence and Machine Learning to add efficiency and precision to pre-operative CT-based planning and analysis.

Single-use NextAR TKA requires a low upfront capital investment from clinics and hospitals and is appropriate for use in ambulatory surgical centers. AR glasses allow the surgeon to visualize surgical actions and information in real-time, directly on the operative field, to retain patient focus and track 3D soft tissue behavior during a surgery.

In September 2020, Medacta announced successful completion in Australia using the first surgery with its NextAR™ TKA system, following recent approval from the region’s Therapeutic Goods Administration.

Surgical Planning Associates (SPA)

SPA introduced the HipInsight™ AR intra-operative guidance system for joint replacement in February 2021. This follows FDA 510(k) clearance of the system, which occurred in January 2021.

HipInsight projects holograms on AR glasses so that surgeons can see what they need to see, when they need to see it, inside the patient’s body.

It is the first FDA-cleared surgical guidance platform to be contained entirely within the Microsoft HoloLens 2™ head-mounted device. The system combines cloud-based preoperative planning and virtual interoperative guidance, and offers a seamless and intuitive solution compared to traditional robotic and navigation systems.

Royal Philips

Philips introduced ClarifEye Augmented Reality Surgical Navigation for minimally invasive spine procedures in February 2021. By combining 2D and 3D visualizations at low x-ray dose with 3D AR, the system provides live intraoperative visual feedback to place pedicle screws during spinal fusion.

Four high-resolution optical cameras augment the surgical field with 3D cone-beam CT imaging. The system combines the view of the surgical field with the internal 3D view of the patient, constructing a 3D AR view. The system visualizes the tip of the ClarifEye Needle as it is navigated along the planned path in the spine. The solution is built on the Philips next-generation Azurion image-guided therapy platform.

Insight Medical Systems

In March 2021, DJO Surgical made a strategic investment in Insight Medical Systems, developer of ARVIS® (Augmented Reality Visualization and Information System). ARVIS combines tracking cameras with both a 3D display and handsfree interface in an integrated eyepiece for total joint arthroplasty. It delivers navigation and patient-specific information at the surgical site in a highly efficient and seamless workflow. The ARVIS system will be compatible with existing surgical helmets, while a single tray of trackable instruments eliminates the need for disposables.

Insight will leverage DJO’s sales channel to launch ARVIS in 2H21. The EMPOWR™ Partial, Primary and Complex Primary Knee and Hip systems will be compatible.

AR technology remains in its infancy in orthopedics. Moving forward, we expect large device companies and technology-focused startups to continue to iterate on the technology to make it more efficient, accurate and easier to use.

HT

Heather Tunstall is a BONEZONE Contributor.

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