Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

October 2, 2009 updated by: Danderyd Hospital

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study

Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-18288
        • Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
  • Patient aged 20-70 years with no previous fracture of either wrist.

Exclusion Criteria:

  • Bilateral fractures,
  • Other current injury to the upper extremities,
  • Dementia, OR
  • Severe comminution or too small distal fragment to allow plating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Volar locked plate
Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate
Procedure: Internal fixation with a volar locked plate
Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate
Other Names:
  • Volar locked plate brand: Königsee by Swemac
OTHER: External fixation
Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation
Procedure: closed reduction and external fixation
Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation
Other Names:
  • External fixation: Hoffman compact

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PRWE (patient rated wrist evaluation) score
Time Frame: 3,6 and 12 months
3,6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective function (range of movement and grip strength)
Time Frame: 3,6 and 12 months
3,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Investigators

  • Principal Investigator: Gustaf Neander, MD, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (ESTIMATE)

October 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2009

Last Update Submitted That Met QC Criteria

October 2, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005/4:8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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