Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction

NCT01823692 | Completed Phase 2 DMC

• 1 other identifier: ASD-1213-75
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Keywords

Radius Fracture; Sensitivity; Reduction; Adequacy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Distal Radius Fracture

OTHER

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?

Other: ultrasonography

Interventions

ultrasonography OTHER

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?

Distal Radius Fracture

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Al-Zahra University Hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Wrist Fractures; Radius Fractures; Hypersensitivity

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Forearm Injuries; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Hamidreza Shemshaki, MD

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research Assistant

Study Record Dates

• First Submitted: March 30, 2013
• First Posted: April 4, 2013
• Study Start: September 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2013-03

Locations

IR (1)