Fractures, BoneNCT00656162
Ultrasound Detection of Radiographically Negative Fractures of Elbow in Children
An observational study of Fractures, Bone, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the management of the fractures of an elbow. In young children the fractures may be suspected clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a regular x-ray. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Fractures, Bone
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jan 2010
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children with clinically suspected but x-ray negative elbow trauma
Who may be able to join
- Signing Informed consent
Who cannot join
- Unwillingness to sign informed consent.
- Any fracture of the same hand or forearm before or after an avaluated event.
Trial locations and contacts
1 site in 1 country.
About this study
Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the management of the fractures of an elbow. In young children the fractures may be suspected clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma in children can be additionally evaluated using high resolution US.
- Conditions
- Fractures, Bone
- Medical subject headings
- Fractures, Bone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656162
- Sponsor's protocol ID
- SIM005-HMO-CTILL
- Status last verified
- Oct 2010
- First submitted
- 6 Apr 2008
- Last updated
- 5 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Detection of Radiographically Negative Fractures of Elbow in Children
- ClinicalTrials.gov ID
- NCT00656162
- Acronym / sponsor ID
- SIM005-HMO-CTILL
- Conditions
- Fractures, Bone
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 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.
Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the management of the fractures of an elbow. In young children the fractures may be suspected clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma in children can be additionally evaluated using high resolution US.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with clinically suspected but x-ray negative elbow trauma
Key inclusion criteria (1 listed)
- Signing Informed consent
Key exclusion criteria (2 listed)
- Unwillingness to sign informed consent.
- Any fracture of the same hand or forearm before or after an avaluated event.
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 5 Nov 2010.
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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.
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 Fractures, Bone, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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 5 Nov 2010. 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 Israel. 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 5 Nov 2010.