Outcome Study of Complex Distal Radius Fractures

Completed

• Conditions: Distal Radius Fractures

• Registration Number: NCT00160810
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this study is to collect information about how people do after different treatments of a broken wrist to see if one treatment has better results.

Detailed Description

Complex distal radius fractures are a common problem treated by orthopaedic surgeons. The purpose of this study is to compare the outcome between complex distal radius fractures treated with open reduction and internal fixation using a volar fixed angled plate versus and external fixator versus DRV. The hypothesis is that the volar fixed angled plate will have a superior outcome both radiographically and clinically.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Primary Completion: 2010-10
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• distal radius fracture

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wrist Range of Motion	one year post-op	An improvement of all aspects of wrist motion (extension, flexion, supination and pronation) over one year post-op.

Secondary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores	one year post-op	An improvement of the DASH and PRWE scores over one year post-op.

Trial Locations

Locations (1)

UF and Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States