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OpenTrials
Completed

NCT Number: NCT00160810

Outcome Study of Complex Distal Radius Fractures

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.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF and Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • distal radius fracture

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Wrist Range of Motion

    Time frame: one year post-op

    An improvement of all aspects of wrist motion (extension, flexion, supination and pronation) over one year post-op.

Secondary outcomes

  1. Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores

    Time frame: one year post-op

    An improvement of the DASH and PRWE scores over one year post-op.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2010
Study completion
2012
First posted
Sep 12, 2005
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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