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

This study has been completed.
Sponsor:
Information provided by:
Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT00989222
First received: October 2, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 2, 2009
October 2, 2009
January 2006
June 2009   (final data collection date for primary outcome measure)
PRWE (patient rated wrist evaluation) score [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Objective function (range of movement and grip strength) [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Radius Fractures
  • Procedure: closed reduction and external fixation
    Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation
    Other Name: External fixation: Hoffman compact
  • 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 Name: Volar locked plate brand: Königsee by Swemac
  • Volar locked plate
    Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate
    Intervention: Procedure: Internal fixation with a volar locked plate
  • External fixation
    Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation
    Intervention: Procedure: closed reduction and external fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00989222
2005/4:8
No
Dr Maria Wilcke, Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden.
Danderyd Hospital
Not Provided
Principal Investigator: Gustaf Neander, MD, PhD Karolinska Institutet
Danderyd Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP