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Image Guided System for Orthopaedic Surgery

This study has been terminated.
(Grant expired)
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00022802
First received: August 14, 2001
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Orthopaedic Trauma
Hip Fracture
Device: Image-guided surgical system
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Image Guided Surgical System for Orthopaedic Trauma

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 40
Study Start Date: December 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022802

Locations
United States, Illinois
Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas C. Kienzle, MD Surgical Insights
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00022802     History of Changes
Other Study ID Numbers: R01 AR44759, NIAMS-054
Study First Received: August 14, 2001
Last Updated: April 7, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Biomedical equipment development
Computer assisted patient care
Digital imaging
Hip surgery
Orthopedics
Trauma
Radiography
Biomedical imaging

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Hip Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014