Completed

Study of Accuracy of Ultrasonography in Determining the Adequacy of Distal Radius Fracture Reduction

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What is being tested

ultrasonography

Other
Who is being recruted

Arm Injuries+6

+ Forearm Injuries

+ Immune System Diseases

Over 21 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: September 2011
See protocol details

Summary

Principal SponsorIsfahan University of Medical Sciences
Last updated: April 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

Distal radius fracture is one of the most common causes for visiting the emergency department. Nowadays, simple radiography is used as a control standard for evaluating reduction of distal radius fractures. The disadvantages include time wasting, frequent x-ray exposures and use of more sedation in determining adequate reduction, made scientists to evaluate alternative method such as ultrasonography which fast, easy and less dangerous were considered as advantages. The investigators goal was to identify whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.

NCT01823692
Principal SponsorIsfahan University of Medical Sciences
Last updated: April 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

184 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arm InjuriesForearm InjuriesImmune System DiseasesWounds and InjuriesWrist InjuriesFractures, BoneWrist FracturesHypersensitivityRadius Fractures

Criteria

1 inclusion criteria required to participate
21 years old and a diagnosing of a distal radius fracture based on simple radiography
6 exclusion criteria prevent from participating
Open fractures
joint internal involvement, communicated and along with Neurovascular compromised fractures
more than 20 degree angulation
need to stay in the ICU and not being able to be treated at the same time for distal radius fracture
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

after manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not?

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Al-Zahra University Hospital

Isfahan, IranOpen Al-Zahra University Hospital in Google Maps
CompletedOne Study Center