Ultrasound Detection of Radiographically Negative Fractures of Elbow in Children

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00656162

First Posted: April 10, 2008

Last Update Posted: November 5, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Hadassah Medical Organization

Purpose

Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the management of the fractures of an elbow. In young children the fractures may be suspected clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma in children can be additionally evaluated using high resolution US.

Condition
Fractures, Bone


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:


Study Start Date:	January 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	up to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

children with clinically suspected but x-ray negative elbow trauma

Criteria

Inclusion Criteria:

Signing Informed consent

Exclusion Criteria:

Unwillingness to sign informed consent.
Any fracture of the same hand or forearm before or after an avaluated event.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656162

Locations


Israel
Hadassah Medical Organization
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

More Information


ClinicalTrials.gov Identifier:	NCT00656162 History of Changes
Other Study ID Numbers:	SIM005-HMO-CTILL
First Submitted:	April 6, 2008
First Posted:	April 10, 2008
Last Update Posted:	November 5, 2010
Last Verified:	October 2010

Additional relevant MeSH terms:


Fractures, Bone Wounds and Injuries

To Top