Adult reconstructive orthopaedic procedures represent a significant, growing class of surgeries. Minimally invasive surgery (MIS), though challenging, has multiple benefits to the patient and healthcare providers. The Precision Freehand Sculptor (PFS), a handheld tool for enabling MIS, assists the surgeon in accurately cutting predetermined shapes in bone. It provides a layer of safety and accuracy and can be applied required over a range of procedures. ? ? Project Hypothesis: The PFS can provide the advantages of MIS to both patients and the healthcare industry without compromising accuracy. ? ? The Phase II Aims are: ? 1: Determine ideal tracking modality for PFS - Assess the viability and relative advantages of using electromagnetic tracking with the PFS. ? 2: Show that the PFS can be used to perform UKR more accurately using MIS than the conventional procedure, without adding significant time to the procedure. ? 3: Refine control algorithm and user interface based on Aim 2 trial feedback ? 4: Design and construct an OR-compatible PFS - Improve the prior design to optimize a new tool for used in cadaveric and eventual human trials. ? 5: Prove feasibility of PFS in the OR setting during cadaver trials - Show feasibility of an MIS PFS unicondylar knee replacement procedure (UKR). Evaluate accuracy, procedure time, and OR ergonomics compared to standard techniques. ? ? Once feasibility of the PFS is shown for UKR, it can be applied to a wider range of orthopaedic procedures, increasing the market for the device while providing further savings to the healthcare providers by providing a general solution to this broader range of applications. ? ?
