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Outcome Study of Complex Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT00160810
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Distal Radius Fractures

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 Design
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Study Type : Observational
Actual Enrollment : 74 participants
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
Study Start Date : April 2001
Actual Primary Completion Date : October 2010
Actual Study Completion Date : June 2012

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Orthopaedic clinic
Criteria

Inclusion Criteria:

  • distal radius fracture

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00160810     History of Changes
Other Study ID Numbers: 86-2001
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: June 2012

Keywords provided by University of Florida:
distal
radius
fractures

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries