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Ultrasound as a Diagnostic Tool for Occult Hip Fractures

NCT ID: NCT00274196

Last Updated: 2007-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Occult Fractures

Keywords

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fractures, occult hip ultrasound examination MRI sensitivity specificity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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ultrasound examination

a single time 10 minutes procedure within the first week after the injury

Intervention Type PROCEDURE

MRI scan

a single time 30 minutes procedure, performed always after the ultrasound scan

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Ori Safran, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Charles Milgrom, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Charles Milgrom, MD

Role: CONTACT

Phone: 00 972 50 7874401

Email: [email protected]

Ori Safran, MD

Role: CONTACT

Phone: 00 972 50 7874705

Email: [email protected]

Facility Contacts

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Arik Tzukert, DMD

Role: primary

Hadas Lemberg, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 15910835 (View on PubMed)

Other Identifiers

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28-17.02.06-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id