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Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
ultrasonography
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Distal Radius Fracture focused on measuring Radius Fracture, Sensitivity, Reduction, Adequacy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • > 21 years old and a diagnosing of a distal radius fracture based on simple radiography.

Exclusion Criteria:

  • Open fractures
  • more than 20 degree angulation
  • joint internal involvement, communicated and along with Neurovascular compromised fractures
  • patient's surgery due to other causes
  • need to stay in the ICU and not being able to be treated at the same time for distal radius fracture
  • patient's refusal to participate in the study

Sites / Locations

  • Al-Zahra University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Distal Radius Fracture

Arm Description

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?

Outcomes

Primary Outcome Measures

adequacy of distal radius fracture reduction
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?

Secondary Outcome Measures

Full Information

First Posted
March 30, 2013
Last Updated
April 2, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01823692
Brief Title
Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction
Official Title
Study of Accuracy of Ultrasonography in Determining the Adequacy of Distal Radius Fracture Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Radius Fracture, Sensitivity, Reduction, Adequacy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distal Radius Fracture
Arm Type
Other
Arm Description
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?
Intervention Type
Other
Intervention Name(s)
ultrasonography
Intervention Description
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?
Primary Outcome Measure Information:
Title
adequacy of distal radius fracture reduction
Description
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?
Time Frame
at 5 min after admission time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: > 21 years old and a diagnosing of a distal radius fracture based on simple radiography. Exclusion Criteria: Open fractures more than 20 degree angulation joint internal involvement, communicated and along with Neurovascular compromised fractures patient's surgery due to other causes need to stay in the ICU and not being able to be treated at the same time for distal radius fracture patient's refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamidreza Shemshaki, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Zahra University Hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.mui.ac.ir
Description
Isfahan University of Medical Sciences

Learn more about this trial

Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction

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