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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
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on November 24, 2014