This project focuses on the further development and clinical testing of an image-guided
surgical system. The system will help surgeons perform procedures that involve inserting a
screw, guide pin, drill bit, or other straight object into bone-for example, inserting
screws in a broken hip bone. These surgeries are currently done with the help of a mobile
x-ray device called a C-arm, which provides the surgeon with x-ray images during the
C-arms have some disadvantages, including image distortion, radiation exposure, and the need
for time-consuming adjustments of the C-arm during the surgery. The new method would deal
with these shortcomings with a computer-based system that adds to the existing C-arm system.
It would provide the surgeon with a real-time view of the insertion process, and could
improve the accuracy and speed of certain surgical procedures.
Disadvantages associated with C-arms include image distortion, radiation exposure, and time
consuming reconfiguration of the C-arm during the insertion process. The proposed system
would address these shortcomings with a computer-based system that augments the existing
This Small Business Innovation Research Phase II project supports the further development
and clinical testing of an image-guided surgical system that will assist the surgeon in
performing procedures that involve the insertion of a screw, guide pin, drill bit, or other
linear object into bone. These surgeries are currently performed with the assistance of a
mobile fluoroscopic x-ray imager known as a C-arm.
Disadvantages associated with C-arms include image distortion, radiation exposure, and
time-consuming reconfiguration of the C-arm (between A/P and lateral views) during the
insertion process. The proposed system would address these shortcomings with a
computer-based system that augments the existing C-arm system. The new system uses an
optical localizer (a stereo camera device that tracks light-emitting diodes) to monitor the
location and orientation of a drill guide in the surgical field. The drill guide trajectory
is then graphically superimposed on the x-ray images. This provides real-time, on-screen
positional feedback to the surgeon to improve the accuracy and speed with which certain
procedures involving insertion of drill bits or guide pins can be performed. The research
effort will focus on the development of a clinical prototype and its evaluation by several
quantitative and qualitative methods.
The commercial success of such a system depends on its acceptance by surgeons, which in turn
depends on the extent to which it is a tool that provides better information to the surgeons
without intruding on a procedure in which they are already highly skilled. Commercial
success also depends on the ability of the system to reliably save time in the operating
room. We will address these issues with cadaveric studies and subsequent clinical trials.
Proposed Commercial Applications: The initial commercial application of this system is the
insertion of dynamic compression hip screws in cases of hip fracture. Because this is a
common fracture, any reduction in surgical time has great potential for cost savings. Other
advantages include decrease in radiation exposure and the potential reduction of serious
complications. Minor modifications that allow the system to assist with numerous other
orthopaedic trauma procedures are already planned.
- Patient must be a candidate for dynamic compression screw fixation of an
intertrochanteric hip fracture.
- Patient must be 18 or older and have a life expectancy of at least 5 years beyond
- Patient must be able to provide written informed consent.
- Patient must agree to abide by the study protocol.
- Patient must not have a concurrent illness that would make extended time under
anesthesia a severe risk.
- Patient must not have a concurrent fracture in the same limb.
- Patient must not have a concurrent open fracture.
- Patient must not have a concurrent highly comminuted fracture or fractures that, in
the surgeon's opinion, would allow excessive motion of the femoral shaft relative to
the femoral head.