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Ultrasound as a Diagnostic Tool for Occult Hip Fractures

This study is currently recruiting participants.
Verified by Hadassah Medical Organization, November 2007

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 related topics:   Fractures    Hip Injuries and Disorders    Hip Replacement    Nuclear Scans    Ultrasound   

U.S. FDA Resources

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

Estimated Enrollment:   30
Study Start Date:   February 2006
Estimated Study Completion Date:   June 2008

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
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.

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274196

Contacts
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    

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

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Principal Investigator:     Ori Safran, MD     Hadassah Medical Organization    
Principal Investigator:     Charles Milgrom, MD     Hadassah Medical Organization    
  More Information

Publications:

Study ID Numbers:   28-17.02.06-HMO-CTIL
First Received:   January 9, 2006
Last Updated:   November 12, 2007
ClinicalTrials.gov Identifier:   NCT00274196
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
fractures, occult  
hip  
ultrasound examination  
MRI
sensitivity
specificity

Study placed in the following topic categories:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Fractures, Closed
Leg Injuries

Additional relevant MeSH terms:
Hip Injuries

ClinicalTrials.gov processed this record on September 05, 2008




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