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
  Purpose

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.


Condition Intervention
Radius Fractures
Procedure: closed reduction and external fixation
Procedure: Internal fixation with a volar locked plate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Danderyd Hospital:

Primary Outcome Measures:
  • PRWE (patient rated wrist evaluation) score [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective function (range of movement and grip strength) [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: January 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Volar locked plate brand: Königsee by Swemac
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 Name: External fixation: Hoffman compact

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00989222

Locations
Sweden
Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
Stockholm, Sweden, S-18288
Sponsors and Collaborators
Danderyd Hospital
Investigators
Principal Investigator: Gustaf Neander, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Dr Maria Wilcke, Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden.
ClinicalTrials.gov Identifier: NCT00989222     History of Changes
Other Study ID Numbers: 2005/4:8
Study First Received: October 2, 2009
Last Updated: October 2, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Danderyd Hospital:
Distal radius fractures
Fractures of the distal radius
Volar plate
External fixation

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

ClinicalTrials.gov processed this record on October 01, 2014