Occult FracturesNCT00274196
Ultrasound as a Diagnostic Tool for Occult Hip Fractures
A study testing ultrasound examination and MRI scan in people with Occult Fractures, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Occult Fractures
- What is being tested?
- ultrasound examination and MRI scan
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2006to Jun 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 years or older, with suspected hip fracture but normal plain X-rays
Who cannot join
- Patients younger than 40 years and with contra-indications for MRI scan
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572
About this study
Official title: A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures
The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures.
Read the detailed description
Introduction: Most hip fractures are diagnosed by history, physical examination and confirmed by plain radiographs. When initial X-rays are negative or equivocal, and there is a clinical suspicion of occult hip fracture, additional diagnostic tests are necessary such as MRI which is expensive and in many hospitals less available, or bone scan which needs to be delayed 48-72 hours from injury to be indicative. Ultrasound examination has been shown to be an accurate measurement to diagnose occult fractures in the ankle and is a relatively easy, available, non-expansive examination. We propose the use of bedside ultrasound examination of the hip as a screening tool for occult hip fractures.
Objective: To measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing or ruling out occult hip fractures.
Materials and methods: We will include all patients 40 years and older with a painful hip after an injury, and with "normal" hip X-rays. Each patient will undergo two hip ultrasounds by two different examiners. Afterwards, the patients will undergo MRI of the hip. The MRI will serve as the gold standard for treatment decisions. The results of the ultrasound will be compared to the MRI to evaluate its sensitivity and specificity.
- Conditions
- Occult Fractures
- Being tested
- ultrasound examination, MRI scan
- Keywords
- fractures, occult, hip, ultrasound examination, MRI, sensitivity, specificity
- Medical subject headings
- Fractures, Closed, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examinationProcedure or surgery
a single time 10 minutes procedure within the first week after the injury
MRI scanProcedure or surgery
a single time 30 minutes procedure, performed always after the ultrasound scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between ultrasound exam and MRI (sensitivity and specificity)
Measured: 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startFeb 2006
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occult FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ori Safran, MD, Principal investigator, Hadassah Medical OrganizationCharles Milgrom, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274196
- Sponsor's protocol ID
- 28-17.02.06-HMO-CTIL
- Status last verified
- Nov 2007
- First submitted
- 9 Jan 2006
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Lubovsky O, Liebergall M, Mattan Y, Weil Y, Mosheiff R. Early diagnosis of occult hip fractures MRI versus CT scan. Injury. 2005 Jun;36(6):788-92. doi: 10.1016/j.injury.2005.01.024. Epub 2005 Apr 7.
PubMed 15910835
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures
- ClinicalTrials.gov ID
- NCT00274196
- Acronym / sponsor ID
- 28-17.02.06-HMO-CTIL
- Conditions
- Occult Fractures
- Keywords
- fractures, occult, hip, ultrasound examination, MRI, sensitivity, specificity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Jun 2008 (estimated)
- First posted
- 10 Jan 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 this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures.
Detailed description
Introduction: Most hip fractures are diagnosed by history, physical examination and confirmed by plain radiographs. When initial X-rays are negative or equivocal, and there is a clinical suspicion of occult hip fracture, additional diagnostic tests are necessary such as MRI which is expensive and in many hospitals less available, or bone scan which needs to be delayed 48-72 hours from injury to be indicative. Ultrasound examination has been shown to be an accurate measurement to diagnose occult fractures in the ankle and is a relatively easy, available, non-expansive examination. We propose the use of bedside ultrasound examination of the hip as a screening tool for occult hip fractures.
Objective: To measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing or ruling out occult hip fractures.
Materials and methods: We will include all patients 40 years and older with a painful hip after an injury, and with "normal" hip X-rays. Each patient will undergo two hip ultrasounds by two different examiners. Afterwards, the patients will undergo MRI of the hip. The MRI will serve as the gold standard for treatment decisions. The results of the ultrasound will be compared to the MRI to evaluate its sensitivity and specificity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 40 years or older, with suspected hip fracture but normal plain X-rays
Key exclusion criteria (1 listed)
- Patients younger than 40 years and with contra-indications for MRI scan
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 |
|---|---|---|
| ultrasound examinationa single time 10 minutes procedure within the first week after the injury | Procedure or surgery | – |
| MRI scana single time 30 minutes procedure, performed always after the ultrasound scan | Procedure or surgery | – |
Primary outcome
Comparison between ultrasound exam and MRI (sensitivity and specificity)
Time frame: 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2007.
- Background: PubMed 15910835Lubovsky O, Liebergall M, Mattan Y, Weil Y, Mosheiff R. Early diagnosis of occult hip fractures MRI versus CT scan. Injury. 2005 Jun;36(6):788-92. doi: 10.1016/j.injury.2005.01.024. Epub 2005 Apr 7.
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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.
Ori Safran, MD principal investigator
Hadassah Medical Organization
Charles Milgrom, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound examination and MRI scan in people with Occult Fractures, 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 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: status not confirmed, as of the sponsor's last update on 14 Nov 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Milgrom, MD (00 972 50 7874401, charles.milgrom@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between ultrasound exam and MRI (sensitivity and specificity) (time frame: 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00274196, which also lists 1 linked publication.
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 14 Nov 2007.