Image Guided System for Orthopaedic Surgery

NCT00022802 | Terminated Phase 2

• 2 other identifiers: R01 AR44759NIAMS-054
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthopaedic Trauma; Hip Fracture

Keywords

Biomedical equipment development; Computer assisted patient care; Digital imaging; Hip surgery; Orthopedics; Trauma; Radiography; Biomedical imaging

Interventions

Image-guided surgical system DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Hip Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Hip Injuries; Leg Injuries

Study Officials

• Thomas C. Kienzle, MD

  Surgical Insights

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 14, 2001
• First Posted: August 16, 2001
• Study Start: December 1, 2002
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: April 9, 2009

Record last verified: 2009-04

Locations

US (1)