The overall success of any kind of orthopedic surgery largely depends on the correct positioning and alignment of elements in the bone anatomy. In knee Anterior Cruciate Ligament (ACL), which is a well-established arthroscopic surgery with 700.000 cases being performed every year, the average success rate is only 85%, with 10% of patients having to undergo revision surgery. The challenging execution of arthroscopy creates a market opportunity for systems and technologies able to assist the surgeon. In Total Knee Arthroplasty (TKA), which is a widespread procedure with about two and a half million cases per year, poor implant alignment contributes to significant patient dissatisfaction (19%) and is directly responsible for 20% of the 300 000 revision procedures performed every year. Computer navigation was introduced 15 years ago, but despite the proven clinical benefits, current market penetration is less than 5%. The reasons are twofold: (i) ergonomics - systems are cumbersome to use, disrupt workflow and add surgery time; (ii) economics - upfront investment in capital equipment makes navigation financially viable only in large volume hospitals.
The objective of this project is, therefore, to develop and bring to market a video-based technology for surgical navigation, that will combine intelligent video processing for 3D mapping of the anatomy with Augmented Reality (AR) for overlaying meaningful guidance information in images. It is the first system of the kind that provides higher metric accuracy while solving the problems of ergonomics (intuitive to use thanks to AR, no lines of sight or bulky markers, minimum additional time) and economics (no capital equipment with software being deployed in a tablet PC). It is also the first effective solution for navigation in arthroscopy which uses the video acquired by the already existing arthroscopic camera.
P3D has successfully demonstrated the technology in ex-vivo experiments both in arthroscopy and open surgery, validating the applicability and potential of the technology for the orthopedic market.
With the conclusion of this project, the company now has a set of software systems that have been validated from a clinical feasibility standpoint and that can either be incorporated into a partner’s surgical navigation platform or can potentiate the future launch of a P3D product.
