Ultrasound as a Diagnostic Tool for Occult Hip Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274196
Recruitment Status : Unknown
Verified November 2007 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : January 10, 2006
Last Update Posted : November 14, 2007
Information provided by:
Hadassah Medical Organization

Brief Summary:
The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures.

Condition or disease Intervention/treatment Phase
Occult Fractures Procedure: ultrasound examination Procedure: MRI scan Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures
Study Start Date : February 2006
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Comparison between ultrasound exam and MRI (sensitivity and specificity) [ Time Frame: 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00274196

Contact: Charles Milgrom, MD 00 972 50 7874401
Contact: Ori Safran, MD 00 972 50 7874705

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572      
Principal Investigator: Ori Safran, MD         
Principal Investigator: Charles Milgrom, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Ori Safran, MD Hadassah Medical Organization
Principal Investigator: Charles Milgrom, MD Hadassah Medical Organization

Publications: Identifier: NCT00274196     History of Changes
Other Study ID Numbers: 28-17.02.06-HMO-CTIL
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: November 2007

Keywords provided by Hadassah Medical Organization:
fractures, occult
ultrasound examination

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Fractures, Closed
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries