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Ultrasound as a Diagnostic Tool for Occult Hip Fractures - Article


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Fractures

Broken Bones; Fracture 




Clinical Trial: Ultrasound as a Diagnostic Tool for Occult Hip Fractures

This study is not yet open for patient recruitment.
Verified by Hadassah Medical Organization January 2006

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00274196

Purpose

The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures.
Condition Intervention
Occult Fractures
 Procedure: ultrasound examination
 Procedure: MRI scan

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title: A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures

Further study details as provided by Hadassah Medical Organization:
Primary Outcomes: Comparison between ultrasound exam and MRI (sensitivity and specificity)
Expected Total Enrollment:  22

Study start: February 2006;  Expected completion: May 2008
Last follow-up: January 2008;  Data entry closure: January 2008

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.

Eligibility

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both
Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00274196

Charles Milgrom, MD      00 972 50 7874401    milgrom@md2.huji.ac.il
Ori Safran, MD      00 972 50 7874705    safran@inter.net.il

Israel
      Hadassah Medical Organization, Jerusalem,  Israel
Arik Tzukert, DMD  00 972 2 6776095    arik@hadassah.org.il 
Hadas Lemberg, PhD  00 972 2 6777572 
Ori Safran, MD,  Principal Investigator
Charles Milgrom, MD,  Principal Investigator

Study chairs or principal investigators

Ori Safran, MD,  Principal Investigator,  Hadassah Medical Organization   
Charles Milgrom, MD,  Principal Investigator,  Hadassah Medical Organization   

More Information

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. Epub 2005 Apr 7.

Study ID Numbers:  28-17.02.06-HMO-CTIL
Last Updated:  January 9, 2006
Record first received:  January 9, 2006
ClinicalTrials.gov Identifier:  NCT00274196
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10

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Page Updated: December 9, 2005
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