Design of an orthopaedic instrument for image guided anterior cruciate ligament reconstruction

This is an interdisciplinary research project in which the methods of Industrial and Product Design Engineering are focused upon a problem in Orthopaedics. One of the most controversial areas in Orthopaedics is the reconstruction of the anterior cruciate ligament (ACL). The current twin-instrument method for locating the ACL is difficult for surgeons with fewer than 500 surgical experiences. This was clearly demonstrated by Kohn, Busche and Cans (1995), and confirmed by Sommer, Friederich and Muller (2000), Sudhahar, Glasgow and Donell (2004), and Kuga, Yasuda, Hata et al. (2004). The above research indicates that the problem is not only one of anatomical location, but of how the operation takes place. The aim of the research was, therefore, to develop a new and improved surgical instrument and technique for locating the ACL anatomical landmarks. The research described in this thesis employs a number of design methods that can be used separately or in combination (hybrid process). They form the theory base that guides the design process. This allows the designer to engage in a flexible process that is effective in finding design solutions to the problem. Within this process, iterative case studies were employed in order to design a new surgical device for ACL reconstruction. The thesis describes a series of designed devices (case studies) that were iteratively developed and surgically tested, leading to a penultimate device. This latter device was tested via a number of surgical operations. The device provides a new method for externally locating the internal ACL attachment points. The research has resulted in a commercial association with Smith and Nephew Surgical Australia and BrainLAB AG Germany for the commercialisation of this technique. At the time of writing, the next stage of research and development is under way. This is using a frameless computer-aided image guidance system in the place of X-ray.