Could augmented reality navigation become the backbone of precision spine surgery?
Estimated reading time: 6-8 minutes
With Philips launching its first augmented reality (AR) solution for minimally-invasive spine surgery this week, we asked Ronald Tabaksblat, Senior Vice President Image Guided Therapy Systems and Electrophysiology Solutions at Philips, about the current state-of-play in spine surgery and how AR could transform its future.
What’s the current state-of-play in treating spine conditions and what are the challenges?
Ronald Tabaksblat: More than half a billion people worldwide experience back pain . Often, it’s due to muscle strain, but the cause can also be more serious, with a range of conditions including degenerative spinal disc disease, cancer, trauma or sideways curvature of the spine, a condition known as scoliosis. While physiotherapy can sometimes help, severe back pain can often be highly debilitating, leaving patients unable to walk or even get out of bed. In many cases, surgery is the only realistic option for long-term relief.
Spine procedures are typically both complex and delicate, with surgeons needing to take particular care to avoid neurological and vascular structures close to the spine, such as the patient’s spinal cord and the aorta. While open surgery – making a large incision so you can physically see the patient’s spine – is the traditional way of performing spine procedures, less trauma-inducing minimally-invasive procedures are becoming increasingly widespread.
What are the benefits of taking a minimally invasive approach?
RT: With an image-guided minimally invasive approach, the physician only needs to make a small incision, through which the devices required to fix the problem can be inserted and guided to the treatment area. Benefits of this approach can include that the patient can experience less postoperative pain, a shorter stay in hospital, reduced blood loss, less soft tissue damage and a reduced chance of infection .
What led Philips to develop its new ClarifEye augmented reality surgical navigation solution?
RT: Improving patient outcomes and enhancing the experience for patients and staff are three key elements of the ‘quadruple aim’ of healthcare, which we are determined to achieve at Philips in the field of spine treatment. And if we can make procedures more efficient, it could also help to achieve the fourth quadruple aim: driving down the cost of care.
One of the most common spine procedures carried out using minimally invasive techniques is the immobilization of adjacent vertebrae to stabilize a patient’s spine with the insertion of stainless steel or titanium alloy pedicle screws and connecting rods. However, placing these screws accurately during minimally-invasive procedures has always been challenging, with additional procedures to make further adjustments after the initial treatment not uncommon.
For some time now we have been developing an AR-based solution that allows surgeons to view a 3D image of the patient’s spinal anatomy during the procedure so they can place pedicle screws with increased confidence and accuracy, while avoiding neurological and vascular damage. Combining imaging and navigation into one solution, we have also focused on providing a smooth workflow for the surgeon. Precise imaging guidance is vital to ensure accurate device placement during such delicate and complex procedures.
How does the ClarifEye augmented reality surgical navigation solution work?
RT: Four high-resolution optical cameras are used to augment the surgical field with 3D cone-beam CT imaging, without the need for additional X-ray. The system combines the view of the surgical field with the internal 3D view of the patient to construct a 3D augmented-reality view of the patient's external and internal anatomy. Patient tracking is ensured by video tracking of non-invasive markers placed on the skin. No external reference frame is needed. Then the system visualizes the tip of the ClarifEye Needle as it is navigated along the planned path on the spinal anatomy.
ClarifEye is fully integrated into our highly successful Azurion image-guided therapy platform for hybrid operating rooms promoting an efficient workflow. We’re proud of the resulting solution: through co-creation with our clinical partners, we’ve developed an innovative integrated solution that supports minimal invasive spine procedures, and as a result, has the potential to improve outcomes, and reduce costs.
How have clinicians reacted to it so far?
RT: A study  performed at Karolinska University Hospital in Sweden – one of the clinical partners we worked with to develop ClarifEye – showed 94% accuracy rate for pedicle screw placement in open procedures with no intra-operative neurological complications. Compared to a non-navigated ‘freehand’ approach, ClarifEye reduced the percentage of misplaced screws from 10.4% to 6.1%. In addition, ClarifEye significantly reduced radiation exposure to staff and patients using the system’s low dose, intra-operative 3D cone beam CT imaging .
Because they can verify whether a procedure has been successful during treatment, clinicians have also reported that post-operative CT scans to check implant placements are no longer necessary. Usability testing with surgeons in the U.S. have also indicated that the system is user-friendly and easy to learn – important factors when you know that steep learning curves are often a barrier to the adoption of new technologies in practice.
How does ClarifEye fit into Philips’ broader image-guided therapy strategy?
RT: Minimally-invasive image guided therapy is a high-growth market for Philips. For spine surgery, it is expected that around 50% of the procedures will be performed using minimally-invasive techniques in the near future.
It’s just one of many areas in which we are successfully implementing our strategy of developing integrated procedural solutions based on our Azurion platform.
 Medtech 2012 US image guided surgery; MRG, 2014, Global markets for MIVCF; MRG 2015, Surgical navigation systems; MRG 2013, US markets for minimal invasive spine technology.  Phan K, Rao PJ, Mobbs RJ. Percutaneous versus open pedicle screw fixation for treatment of thoracolumbar fractures: Systematic review and meta-analysis of comparative studies. Clinical neurology and neurosurgery. 2015. 135:85-92.  Elmi-Terander at el, Augmented reality navigation with intraoperative 3D imaging vs fluoroscopy-assisted free-hand surgery for spine fixation surgery, a matched-control study, Nature Sci. rep. 2020 Jan 20;10(1):707.  Erik Edström. at el, Augmented Reality Surgical Navigation in Spine Surgery to Minimize Staff Radiation Exposure., Prospective observational study, SPINE: Jan 1, 2020 - Volume 45 - Issue 1 - p E45-E53.
ClarifEye Augmented Reality Surgical Navigation is not available in the USA. FDA 510(k) approval is pending. Results from case studies are not predictive of results in other cases. Results in other cases may vary. This material is not for distribution in the U.S.A.
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