FracturesNCT00972647
Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures
A study testing Laser beam guidance in people with Fractures, run by Loma Linda University at 1 site in United States.
Trial summary
Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially during intraoperative fluoroscopy. It is expected that using a laser guided fluoroscopy technique, which should improve accuracy of radiography, should also reduce the amount of time of exposure to radiation. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Fractures
- What is being tested?
- Laser beam guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2011
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with fractures requiring surgery with fluoroscopic assistance
Who cannot join
- Patients with fractures treated without surgery
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially during intraoperative fluoroscopy. It is expected that using a laser guided fluoroscopy technique, which should improve accuracy of radiography, should also reduce the amount of time of exposure to radiation. Finally, the literature appears controversial in this matter with no clear conclusions that could be drawn from such.
Hypothesis: The test hypothesis is that the use of the laser-aiming device for fluoroscopy in several orthopaedic procedures will reduce the exposure of the patient and the surgeon to the damaging effects of radiation. The null hypothesis then states that there will be no difference in exposure to radiation between the group using the laser device and the group not using the apparatus.
Read more
Methods: A prospective randomized controlled trial will be performed in which patients undergoing fluoroscopy will be randomly allocated to two groups. One group will undergo imaging with use of the device throughout the procedure and the other group will undergo radiation without the laser guided device. Number and time of exposure will be recorded for each procedure. It is of the utmost importance that the complexity of the procedures remains relatively similar. It is believed that a good measure of complexity is the surgical time. Therefore, any procedures that are statistically similar from a set mean (p > 0.05) would be included into the study. It is also important that one or two surgeons with similar expertise and years of experience perform the surgeries to avoid confounding factors. It is expected that throughout the duration of the study (8 weeks) 50-100 cases would be reported which would produce statistically significant results. The results will be analyzed by calculating confidence intervals and differences between means of continuous data and significance levels by the Student's t test. Statistical significance will be set to P < 0.05.
Risks and Benefits: This study involves minimal risk. The use of the laser guide will not increase or introduce any risks other than the associated inherent surgical risks. The risks usually associated with this type of studies concern breach of confidentiality. To reduce this risk, research numbers will be assigned to subjects' data collected during the procedure, whose personal information will be found in another password-protected database.
This study will help the investigators to investigate a technique that may help reduce the amount of time that a patient is exposed to radiation.
- Conditions
- Fractures
- Being tested
- Laser beam guidance
- Keywords
- fracture, fixation, fluoroscopy, laser, radiation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser beam guidanceProcedure or surgery
Using the laser centralizing beam to assist in position the body part prior to fluoroscopic imaging
| Study group | Role | What they receive |
|---|---|---|
| Unguided | No intervention | Fluoroscopy images taken without laser beam guidance |
| Laser guided | Experimental | Fluoroscopy images taken with laser beam guidance Receives: Procedure: Laser beam guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of radiation exposure
Measured: 1 to 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: Lack of personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montri D. Wongworawat, Loma Linda University
- Investigators
- Montri D Wongworawat, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972647
- Sponsor's protocol ID
- 59130
- Status last verified
- Sep 2013
- First submitted
- 20 Aug 2009
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures
- ClinicalTrials.gov ID
- NCT00972647
- Acronym / sponsor ID
- 59130
- Conditions
- Fractures
- Keywords
- fracture, fixation, fluoroscopy, laser, radiation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 7 Sep 2009 (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.
Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially during intraoperative fluoroscopy. It is expected that using a laser guided fluoroscopy technique, which should improve accuracy of radiography, should also reduce the amount of time of exposure to radiation. Finally, the literature appears controversial in this matter with no clear conclusions that could be drawn from such.
Hypothesis: The test hypothesis is that the use of the laser-aiming device for fluoroscopy in several orthopaedic procedures will reduce the exposure of the patient and the surgeon to the damaging effects of radiation. The null hypothesis then states that there will be no difference in exposure to radiation between the group using the laser device and the group not using the apparatus.
Methods: A prospective randomized controlled trial will be performed in which patients undergoing fluoroscopy will be randomly allocated to two groups. One group will undergo imaging with use of the device throughout the procedure and the other group will undergo radiation without the laser guided device. Number and time of exposure will be recorded for each procedure. It is of the utmost importance that the complexity of the procedures remains relatively similar. It is believed that a good measure of complexity is the surgical time. Therefore, any procedures that are statistically similar from a set mean (p > 0.05) would be included into the study. It is also important that one or two surgeons with similar expertise and years of experience perform the surgeries to avoid confounding factors. It is expected that throughout the duration of the study (8 weeks) 50-100 cases would be reported which would produce statistically significant results. The results will be analyzed by calculating confidence intervals and differences between means of continuous data and significance levels by the Student's t test. Statistical significance will be set to P < 0.05.
Risks and Benefits: This study involves minimal risk. The use of the laser guide will not increase or introduce any risks other than the associated inherent surgical risks. The risks usually associated with this type of studies concern breach of confidentiality. To reduce this risk, research numbers will be assigned to subjects' data collected during the procedure, whose personal information will be found in another password-protected database.
This study will help the investigators to investigate a technique that may help reduce the amount of time that a patient is exposed to radiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unguided | No intervention | –Fluoroscopy images taken without laser beam guidance |
| Laser guided | Experimental | Procedure: Laser beam guidanceFluoroscopy images taken with laser beam guidance |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with fractures requiring surgery with fluoroscopic assistance
Key exclusion criteria (1 listed)
- Patients with fractures treated without surgery
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 |
|---|---|---|
| Laser beam guidanceUsing the laser centralizing beam to assist in position the body part prior to fluoroscopic imaging | Procedure or surgery | Laser guided |
Primary outcome
Duration of radiation exposure
Time frame: 1 to 12 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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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.
Montri D Wongworawat, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser beam guidance in people with Fractures, run by Loma Linda University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Oct 2013. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Duration of radiation exposure (time frame: 1 to 12 weeks after surgery). It is what the study was designed to measure, not a finding.
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 1 Oct 2013.