Nasal FractureNCT00650650
Comparison of Ultrasound Versus Radiography for Diagnosis of Nasal Fractures
An observational study of Nasal Fracture, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
Trial summary
The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral nasal view and occipitomental view). But technological advances in ultrasonography during the last few decades have made high-resolution ultrasound devices available to the majority of medical centers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasal Fracture
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Apr 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected nasal fracture.
Who may be able to join
- suspected nasal fracture
Who cannot join
- further fractures
- pregnancy
- unstable condition
- refusal to undergo ultrasound examination
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Hals-Nasen-Ohrenheilkunde, LMU München
München, Bavaria, 81377
About this study
The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral nasal view and occipitomental view). But technological advances in ultrasonography during the last few decades have made high-resolution ultrasound devices available to the majority of medical centers. It has been shown that the bony structures of the nose can be well examined by ultrasound in the last few years. The hypothesis: "Is ultrasound of equal diagnostic accuracy in diagnosing nasal fractures as radiography" is being tested in the investigators' study. Patients with suspected nasal fracture undergo ultrasound examination in addition to the routine x-ray imaging. After completion of treatment, the readings of both ultrasound and radiographs are compared in terms of sensitivity and specificity to diagnose nasal fractures.
- Conditions
- Nasal Fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum der Universitaet Muenchen, Grosshadern
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650650
- Sponsor's protocol ID
- NF-US-XR-05
- Status last verified
- Apr 2009
- First submitted
- 28 Mar 2008
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Versus Radiography for Diagnosis of Nasal Fractures
- ClinicalTrials.gov ID
- NCT00650650
- Acronym / sponsor ID
- NF-US-XR-05
- Conditions
- Nasal Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Klinikum der Universitaet Muenchen, GrosshadernUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 2 Apr 2008 (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.
The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral nasal view and occipitomental view). But technological advances in ultrasonography during the last few decades have made high-resolution ultrasound devices available to the majority of medical centers. It has been shown that the bony structures of the nose can be well examined by ultrasound in the last few years. The hypothesis: "Is ultrasound of equal diagnostic accuracy in diagnosing nasal fractures as radiography" is being tested in the investigators' study. Patients with suspected nasal fracture undergo ultrasound examination in addition to the routine x-ray imaging. After completion of treatment, the readings of both ultrasound and radiographs are compared in terms of sensitivity and specificity to diagnose nasal fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected nasal fracture.
Key inclusion criteria (1 listed)
- suspected nasal fracture
Key exclusion criteria (4 listed)
- further fractures
- pregnancy
- unstable condition
- refusal to undergo ultrasound examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2009.
Related trials for Nasal Fracture
Recruiting
Ultrasound-assisted Nasal Bone Fracture Reduction
Nasal Bone Fracture, Ultrasound
Active, not recruitingPhase 4
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
Surgical Site Infection
Active, not recruitingPhase 3
Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.
Ankle Fractures
Enrolling by invitationObservational study
Multi-Institutional IMPACT Validation
Facial Injuries, Mandible Fracture
Not yet recruiting
Early Management of Fracture Nose in Pediatric Patients
Fracture Nose
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Fracture, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 21 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 21 Apr 2009.