Image Guided System for Orthopaedic Surgery

Stopped early · Phase 2

Conditions studied: Orthopaedic Trauma, Hip Fracture

In brief

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 procedure. 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 C-arm system.

Key facts

Study ID

NCT00022802

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

40

Starts

2002-12-01

Expected to finish

2004-04-01

Last updated by the study team

2009-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 their enrollment.
• Patient must be able to provide written informed consent.
• Patient must agree to abide by the study protocol.

You may not qualify if…

• 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.

Where it is running

• Lutheran General Hospital — Park Ridge, Illinois, United States

Full record on ClinicalTrials.gov

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