Ultrasound as a Diagnostic Tool for Occult Hip Fractures

Occult Fractures Clinical Trial

Official title:

A Prospective Study of the Specificity and Sensitivity of Ultrasound in Diagnosing Occult Hip Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00274196
• Other study ID #: 28-17.02.06-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2006
• Last updated: November 12, 2007
• Start date: February 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2007
• Source: Hadassah Medical Organization
• Contact: Charles Milgrom, MD
• Phone: 00 972 50 7874401
• Email: charles.milgrom[@]ekmd.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Occult Fractures

Intervention

Procedure:
• ultrasound examination
a single time 10 minutes procedure within the first week after the injury
• MRI scan
a single time 30 minutes procedure, performed always after the ultrasound scan

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between ultrasound exam and MRI (sensitivity and specificity)		2008