Orthopaedic TraumaPhase 2NCT00022802
Image Guided System for Orthopaedic Surgery
A Phase 2 study testing Image-guided surgical system in people with Orthopaedic Trauma and Hip Fracture, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopaedic Trauma, Hip Fracture
- What is being tested?
- Image-guided surgical system
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: Image Guided Surgical System for Orthopaedic Trauma
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.
Read the 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.
- Conditions
- Orthopaedic Trauma, Hip Fracture
- Being tested
- Image-guided surgical system
- Keywords
- Biomedical equipment development, Computer assisted patient care, Digital imaging, Hip surgery, Orthopedics, Trauma, Radiography, Biomedical imaging
- Medical subject headings
- Hip Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-guided surgical systemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2001 (estimated)
- Study startDec 2002
- Primary completionApr 2004
- Study completionApr 2004
Why it stopped: Grant expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas C. Kienzle, MD, Principal investigator, Surgical Insights
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022802
- Sponsor's protocol ID
- R01 AR44759
- Other IDs
- NIAMS-054
- Status last verified
- Apr 2009
- First submitted
- 14 Aug 2001
- Last updated
- 9 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided Surgical System for Orthopaedic Trauma
- ClinicalTrials.gov ID
- NCT00022802
- Acronym / sponsor ID
- R01 AR44759
- Conditions
- Orthopaedic Trauma, Hip Fracture
- Keywords
- Biomedical equipment development, Computer assisted patient care, Digital imaging, Hip surgery, Orthopedics, Trauma, Radiography, Biomedical imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant expired
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Dec 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 16 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-guided surgical system | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Grant expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C. Kienzle, MD principal investigator
Surgical Insights
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Image-guided surgical system in people with Orthopaedic Trauma and Hip Fracture, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Grant expired). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2009; AzTrials last refreshed its copy on 27 Oct 2026.