- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00274196
Ultrasound as a Diagnostic Tool for Occult Hip Fractures
A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
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Contact:
- Hadas Lemberg, PhD
- Phone Number: 00 972 2 6777572
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Principal Investigator:
- Ori Safran, MD
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Principal Investigator:
- Charles Milgrom, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 40 years or older, with suspected hip fracture but normal plain X-rays
Exclusion Criteria:
- Patients younger than 40 years and with contra-indications for MRI scan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison between ultrasound exam and MRI (sensitivity and specificity)
Time Frame: 2008
|
2008
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ori Safran, MD, Hadassah Medical Organization
- Principal Investigator: Charles Milgrom, MD, Hadassah Medical Organization
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28-17.02.06-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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