Outcome Study of Complex Distal Radius Fractures

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00160810

First received: September 8, 2005

Last updated: May 17, 2013

Last verified: June 2012

History of Changes

Purpose

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.

Condition	Phase
Distal Radius Fractures	Phase 4


Study Type:	Observational
Study Design:	Observational Model: Case-Only
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

Resource links provided by NLM:

MedlinePlus related topics: Arm Injuries and Disorders Fractures

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Wrist Range of Motion [ Time Frame: one year post-op ] [ Designated as safety issue: No ]
An improvement of all aspects of wrist motion (extension, flexion, supination and pronation) over one year post-op.

Secondary Outcome Measures:

Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores [ Time Frame: one year post-op ] [ Designated as safety issue: No ]
An improvement of the DASH and PRWE scores over one year post-op.


Enrollment:	74
Study Start Date:	April 2001
Study Completion Date:	June 2012
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	19 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Orthopaedic clinic

Criteria

Inclusion Criteria:

distal radius fracture

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160810

Locations


United States, Florida
UF and Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Investigators


Principal Investigator:	Thomas W. Wright, M.D.	University of Florida

More Information


Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00160810 History of Changes
Other Study ID Numbers:	86-2001
Study First Received:	September 8, 2005
Last Updated:	May 17, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:


distal radius fractures

Additional relevant MeSH terms:


Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries

ClinicalTrials.gov processed this record on September 29, 2016

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