CAS systems almost invariably involve three major technological components for the discrete steps of data acquisition, registration, and tracking: precise and accurate navigation is directly linked to conceptual design choices from each of the three components detailed above. To date, no single commercial provides a truly integrated imaging and navigation solution simple to use yet extremely precise and adapted to multiple applications and medical scenario. Existing systems require cumulative capital investments: navigation devices cost around $140,000 to $220,000, and trauma software and additional tools may cost up to $60,000 while state of the art imaging devices with 2D/3D and navigation capacity can cost up to $1M. For CAS systems to gain more popularity and advance its application in trauma and orthopaedic surgery, it is key that medical device manufacturers address critical technological, operational and economic considerations, embedding the feedback of clinical experts into the technology development pathway. This is the core philosophy of the SURGIS project which allowed to overcome key conceptual hurdles of CAS devices.
Wider socio-economic impact
By the year 2030, over 1⁄2 of the adults in the EU population will be over aged 65 years. The economic effect of spine, hip and knee disorders of this aging population will have profound implications on the future affordability and availability of quality care. Based on surveys carried out in Canada, the United States, and Western Europe, physical disabilities caused by musculoskeletal conditions assume a 4%-5% prevalence in the adult population. Symptomatic degenerative spinal disorders are treated with a myriad of treatment strategies ranging from medical management, physical therapy, chiropractic adjustments, injections, to complex spine surgery. In 2005, $85.9 billion was spent on the treatment of low back pain, representing a 65% increase from 1997. However, a shift in health economics is occurring, away from traditional fee-for-service medicine, toward a value-based health care system where resource allocation will favor interventions that demonstrate both clinical efficacy and “value for money”.
Despite increased equipment and instrumentation costs, current data suggest that acute care costs for MIS spine surgery are significantly lower than for open surgical interventions, and thus may offset potential higher upfront costs of many MIS implants and equipment. Although data are still sparse, the cumulative effects of lower complication and infection rates, shorter length of stay (LOS), less blood loss, and potentially lower post-discharge resource utilisation, combined with a potentially quicker return to work, will clearly alter the direct and indirect costs of spine care. The use of surgical navigation is directly correlated to a reduction in implant malposition, from a rate of 15.3% in conventional surgery to 3.2% using surgical navigation. The total cost associated with the revision of a lumbar fusion is estimated at $ 32,915 ± $ 8344. The SURGIS project will accelerate the uptake of MIS techniques by providing surgeon with a set of dedicated, user-friendly tools that help them consistently achieve the targeted clinical outcomes and hence one major impact of the project will be to promote significant savings for both public and private health systems.
MIS has changed the paradigm of radiation risk for the surgical team. Radiation exposure to the surgical team is related to the indirect visualization of anatomic structures. Exposure is particularly high in spinal surgery as fluoroscopic guidance is used routinely during interventions and several studies have highlighted the importance of managing this risk for patients and operating room staff. To reduce this exposure, it is crucial to develop technologies such as 3D navigation that minimize the need for multiple x-ray images during surgery. One of the core differentiating technology of the SURGIS device is the inclusion of a proprietary X-ray dose optimisation algorithm that automatically calculates image acquisition parameters while limiting X-ray exposure and ensuring highest image quality to ensure the safety of patients and OR staff alike.
The last major societal impact of SURGIS is to consider access to care of obese patients, a population which often do not benefit from the latest technological advances in surgical devices. Obesity is one of the most prevalent health problems facing the United States today. While some commercial systems (e.g. O-arm fluoroscopes) display inherent design limitations to treat this specific patient population, the SURGIS system was conceptualised from its inception with these considerations in mind affecting the general design in terms of size and power of device, the development of specific MIS surgical instruments and specifically adapted protocols and device trajectories.
