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Ultrasound as a Diagnostic Tool for Occult Hip Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00274196
First received: January 9, 2006
Last updated: November 12, 2007
Last verified: November 2007

January 9, 2006
November 12, 2007
February 2006
Not Provided
Comparison between ultrasound exam and MRI (sensitivity and specificity) [ Time Frame: 2008 ]
Comparison between ultrasound exam and MRI (sensitivity and specificity)
Complete list of historical versions of study NCT00274196 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Ultrasound as a Diagnostic Tool for Occult Hip Fractures
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Occult Fractures
  • Procedure: ultrasound examination
    a single time 10 minutes procedure within the first week after the injury
  • Procedure: MRI scan
    a single time 30 minutes procedure, performed always after the ultrasound scan
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2008
Not Provided

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
Both
40 Years and older
No
Contact: Charles Milgrom, MD 00 972 50 7874401 charles.milgrom@ekmd.huji.ac.il
Contact: Ori Safran, MD 00 972 50 7874705 oris@hadassah.org.il
Israel
 
NCT00274196
28-17.02.06-HMO-CTIL
No
Not Provided
Hadassah Medical Organization
Not Provided
Principal Investigator: Ori Safran, MD Hadassah Medical Organization
Principal Investigator: Charles Milgrom, MD Hadassah Medical Organization
Hadassah Medical Organization
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP