Ultrasound as a Diagnostic Tool for Occult Hip Fractures
Primary Purpose
Occult Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ultrasound examination
MRI scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Occult Fractures focused on measuring fractures, occult, hip, ultrasound examination, MRI, sensitivity, specificity
Eligibility 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
Sites / Locations
- Hadassah Medical OrganizationRecruiting
Outcomes
Primary Outcome Measures
Comparison between ultrasound exam and MRI (sensitivity and specificity)
Secondary Outcome Measures
Full Information
NCT ID
NCT00274196
First Posted
January 9, 2006
Last Updated
November 12, 2007
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00274196
Brief Title
Ultrasound as a Diagnostic Tool for Occult Hip Fractures
Official Title
A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occult Fractures
Keywords
fractures, occult, hip, ultrasound examination, MRI, sensitivity, specificity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ultrasound examination
Intervention Description
a single time 10 minutes procedure within the first week after the injury
Intervention Type
Procedure
Intervention Name(s)
MRI scan
Intervention Description
a single time 30 minutes procedure, performed always after the ultrasound scan
Primary Outcome Measure Information:
Title
Comparison between ultrasound exam and MRI (sensitivity and specificity)
Time Frame
2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Milgrom, MD
Phone
00 972 50 7874401
Email
charles.milgrom@ekmd.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ori Safran, MD
Phone
00 972 50 7874705
Email
oris@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ori Safran, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Milgrom, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
First Name & Middle Initial & Last Name & Degree
Ori Safran, MD
First Name & Middle Initial & Last Name & Degree
Charles Milgrom, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15910835
Citation
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. doi: 10.1016/j.injury.2005.01.024. Epub 2005 Apr 7.
Results Reference
background
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Ultrasound as a Diagnostic Tool for Occult Hip Fractures
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