Fractures, OccultNCT00367848
Efficacy of Ultrasound in Evaluating Occult Fractures
An observational study of Fractures, Occult, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating occult fractures. We want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Fractures, Occult
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2006to not given
- 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
Who may be able to join
- boys and girls aged <=15 years
- suspected fracture of the wrist or ankle (no later than one week after the injury)
- negative or inconclusive x-ray
Who cannot join
- unwillingness to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Ultrasound in Evaluating Fractures in the Ankle and Foot in Children When the X-Ray Does Not Demonstrate Fractures.
The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating occult fractures. We want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive.
- Conditions
- Fractures, Occult
- Keywords
- suspected fractures in the ankle and wrist
- Medical subject headings
- Fractures, Closed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, OccultStudies 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Naum Simanovski, Dr., Principal investigator, Hadassah Medical OrganizationNatalia Simanovski, Dr., Study chair, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367848
- Sponsor's protocol ID
- SIM001- HMO-CTIL
- Status last verified
- May 2008
- First submitted
- 22 Aug 2006
- Last updated
- 20 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound in Evaluating Fractures in the Ankle and Foot in Children When the X-Ray Does Not Demonstrate Fractures.
- ClinicalTrials.gov ID
- NCT00367848
- Acronym / sponsor ID
- SIM001- HMO-CTIL
- Conditions
- Fractures, Occult
- Keywords
- suspected fractures in the ankle and wrist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2006
- First posted
- 23 Aug 2006 (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 purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating occult fractures. We want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- boys and girls aged <=15 years
- suspected fracture of the wrist or ankle (no later than one week after the injury)
- negative or inconclusive x-ray
Key exclusion criteria (1 listed)
- unwillingness to sign informed consent
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 20 May 2008.
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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.
Naum Simanovski, Dr. principal investigator
Hadassah Medical Organization
Natalia Simanovski, Dr. study chair
Hadassah Medical Organization
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, Occult, 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 3 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: finished, as of the sponsor's last update on 20 May 2008. 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 20 May 2008.