Outcome Study of Complex Distal Radius Fractures

Distal Radius Fractures Clinical Trial

Official title:

Outcome Study of Complex Distal Radius Fractures: Open Reduction Internal Fixation (ORIF) With A Volar Fixed Angled Plate Versus A Distal Radius Volar (DRV) Plate Versus External Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160810
• Other study ID #: 86-2001
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: May 17, 2013
• Start date: April 2001
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• distal radius fracture

Exclusion Criteria:

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Locations

Country	Name	City	State
United States	UF and Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wrist Range of Motion	An improvement of all aspects of wrist motion (extension, flexion, supination and pronation) over one year post-op.	one year post-op	No
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores	An improvement of the DASH and PRWE scores over one year post-op.	one year post-op	No