Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823692
• Other study ID #: ASD-1213-75
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2013
• Last updated: April 2, 2013
• Start date: September 2011
• Est. completion date: September 2011

Study information

• Verified date: March 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• ultrasonography
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?

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-Zahra University Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	at 5 min after admission time	Yes

External Links

•   Isfahan University of Medical Sciences